Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

Much has been written about how supportive the pharmaceutical industry has been about US healthcare reform. Prior to the debate, the Obama administration gleefully announced that pharma will give $80 billion in drug discounts in exchange for certain assurances that weren’t publicly disclosed. As most of us know, the US House of Representatives passed historic healthcare reform legislation last week and in addition to a public option it stipulates that pharma will be required to give $140 billion in drug discounts. According to Ed Silverman over at the newly reinstated Pharmalot blog, AstraZeneca CEO David Brennan, who is also this year’s chair of the industry trade group PhRMA, vowed that pharma would fight the house healthcare reform legislation. 

While Brennan’s statement isn’t surprising nor particularly noteworthy, his comments explaining pharma’s position on healthcare reform are revealing and important to understand. He told the Huffington Post “We said there were principles we didn’t want to see violated. And if those principles - price controls, Medicare rebates, moving dual eligibles back from Medicare and back into the Medicaid discount program - if those things happen, I can’t see how we could be supportive of the program.” In other words, we will support anything you propose— and may even be willing to kick in another $60 billion or so to support healthcare reform— but any discussion about government regulation of drug prices is a deal breaker! 

To my knowledge, this is the first public mention of price controls by any pharmaceutical executive during the almost year long debate on healthcare reform. The reason that I find Brennan’s statement interesting is that I have long contended that pharma will give the Obama administration and Congress anything it wants in exchange for assurances that the government will not attempt to control drug prices. For those of you who don’t know, the US is one of the only countries in the world where the government is prohibited from setting drug prices. This means that US drug makers in concert with insurance companies and third party payors can set drug prices based on what the American pharmaceutical market can bear. Not surprisingly, the profit margins on drugs sold in the US are the highest in the world. Obviously, pharma doesn’t want the US government hindering or limiting their profits by setting or capping drug prices. 

I am glad that pharma has finally decided to publicly “come clean” on the price control issue. The public option and issues surrounding data exclusivity for follow-on biologics pale in comparison to the financial havoc that price controls would wreak on the pharmaceutical industry. And, I suspect that pharma and its lobbyists will do whatever it takes to insure that price controls never become a reality in the US. However, at the end of the day, government regulation of drug and device prices will ultimately be required for any meaningful changes to take place to the US healthcare system.

Hat tip to Ed!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

Addendum: After writing this post this weekend, an article appeared in Monday's New York Times that revealed that the drug industry has quietly been raising its wholesale prices on prescription drugs over the past year.  This, of course, was done in anticipation of possible federal legislation that might impose some government controls on drug pricing.  According to the Times article: "In the last year, the industry has raised the wholesale prices of brand-name prescription drugs by about 9 percent, according to industry analysts. That will add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year. By at least one analysis, it is the highest annual rate of inflation for drug prices since 1992. The drug trend is distinctly at odds with the direction of the Consumer Price Index, which has fallen by 1.3 percent in the last year.  Not surprisingly, the US pharmaceutical industry justifies the practice because as an industry spokesperson put it  "they are having to raise prices to maintain the profits necessary to invest in research and development of new drugs as the patents on many of their most popular drugs are set to expire over the next few years."  Hmmmm, interesting comment considering the US pharmaceutical industry has layed off over 180,000 employees over the past three years, a majority of whom are R&D scientists...go figure!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Yesterday, Sanofi-aventis (S-A) agreed to acquire a controlling stake in Indian vaccine maker, Shantha Biotechnics, for an undisclosed amount. And, recently, Abbott announced a definitive agreement to acquire the nutrition businesses of Wockhardt Limited, Carol Info Services Limited, and certain Wockhardt subsidiaries and group companies for consideration totaling approximately US$130 million in cash.

While these two recent acquisitions don’t appear to be particularly noteworthy, they speak volumes about growing Indian influence in biologics and, perhaps more importantly, in biosimilars. India, long known for its expertise in generic drug development and its ability to work with US-based companies, has expanded beyond generic pharmaceuticals into generic biologics aka biosimilars. Biosimilars have been on the Indian market for over a decade and by all accounts several Indian companies, most notably BioCon, might be able to steal biosimilar market share in Asia from the likes of Sandoz, Merck and Teva—companies expected to be major players in the emerging biosimilar market.

Both Shantha and Wockhardt possess substantial experience in biosimilar development and commercialization. To that end, Sanofi-aventis has publicly announced its desire to get into biotechnology and Abbot must expand its biotechnology pipeline beyond Humira to remain competitive. These acquisitions likely represent Sanofi’s and Abbott’s attempt to gain a foothold in the emerging Asian markets. Also, it gives both companies access to lower cost biologics R&D and manufacturing capabilities.

It will be interesting to see how things unfold over the next year or so!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The rancorous debate over a regulatory approval pathway for follow-on biologics (aka biosimilars) continues to rage on in the US Congress. Despite recommendations from the Federal Trade Commission that a data exclusivity period for follow-on biologics isn't necessary and a seven year compromise offered by President Obama,the pharmaceutical and biotechnology lobbies continue to press Congress for a 12 to 14 year period of data exclusivity in any legislation for follow-on biologics. 

In a well-balanced article in today’s New York Times, Andrew Pollack diligently put forth the arguments against follow-on biologics that innovator companies have been espousing for the past decade. These include: complexity of the manufacturing processes for biotechnology drugs, potential tolerability and safety issues and perhaps, most importantly, an anticipated loss of profits that innovator companies claim “would stifle American innovation” in the life sciences. Until recently, these arguments were successfully used to hinder any substantive debates on follow-on biologics legislation. However, it  has become increasingly apparent that the American healthcare system can no longer sustain the high costs and lack of access to potentially life-saving branded biotechnology drugs. For those of you who may not know, a regulatory approval pathway for biosimilars already exists in Europe and it has been used to approve eight products since its inception in 2004.  Biosimilars are also available in Australia and have been sold for many years in less-regulated markets including India, China and elsewhere. Japan recently approved legislation for approval of biosimilars and Canada is close to finalizing its regulatory guidelines for these products.

American innovator companies recognizing the inevitability of follow-on biologics, no longer oppose legislation for approval of these molecules. Instead, these companies and their supporters have tenaciously latched on to the data exclusivity argument, presumably in a last ditch effort to preserve their profits from multibillion dollar biotechnology drug franchises that may be lost when follow-on biologics legislation is enacted.  And, for the most part, their uncompromising insistence on an excessively long data exclusivity period appears to be taking hold with members of Congress. At last count, there were more Congressional sponsors of legislation favoring a 12 to 14 year data exclusivity period than there was for those who support a 5 year data exclusively period. The five year data exclusivity period was proposed by follow-on biologics proponents because it is identical to the period required for generic versions of small molecule drugs enacted in the Hatch Waxman Act.

I have been following the follow-on biologic debate for the past eight years and, to date, I know of no scientific claims or relevant safety concerns which argue that 12 to 14 years of data exclusivity is warranted for follow-on products.  For example, no untoward safety or tolerability problems have been reported for any of the eight biosimilar products that were approved and sold in Europe for the past three years. Further, European healthcare agencies and physicians haven’t readily embraced biosimilars despite an almost 25%-30% reduction in price. The one exception is Germany (the largest generic market in Europe), where biosimilar versions of erythropoietin (Eprex) have captured 30% of the anemia market. This, in turn, has  forced some innovator companies to lower prices on their branded products.

Based on the European experience, it is likely that follow-on biologics won’t catch on quickly in the US and it may take years for them to erode the market share garnered by innovator brands.  Also, contrary to earlier assertions, it is becoming increasingly apparent that only large, well capitalized companies with sophisticated regulatory, marketing and distribution capabilities will be able to compete in the US follow-on biologics market. To that end, companies like Sandoz (Novartis) and Merck—one of the companies that originally opposed follow-on biologics legislation—will likely dominant the US follow-on biologics market.

Ironically, the biggest losers in the follow-on biologics debate will likely be the innovator companies—but not for the reasons they once cited to prevent regulatory approval of these molecules. By spending hundreds of millions of dollars lobbying against follow-on biologics legislation—rather than investing to develop their own lower cost, generic versions of blockbuster biotechnology products—innovator companies have unwittingly provided foreign follow-on biologics manufacturers with a competitive advantage when follow-on biologics are finally approved for sale in the US. Companies like Sandoz, Teva and several Indian biosimilar companies— with products already on the market in Europe, India and China—have been developing biosimilar molecules for the past fiver years or more. Their scientific and regulatory experiences with these products suggests that they will be poised to dominate the US market after legislation permitting approval and sale of follow-on biologics is finally completed. Surprisingly, Merck is the only major pharmaceutical company to publicly announce its intention to compete in the follow-on biologics market. The Merck announcement was made last fall—almost three years after Sandoz won European approval for Omnitrope, its first biosimilar product!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As the Congressional debate over follow-on biologics slogs on, the Obama Administration has finally weighed in and backs 7 years of data exclusivity for follow-on biologics. As you may recall, innovator companies want a 12-14 year data exclusivity period whereas follow-on biologics manufacturers are seeking a 5-year period (which is identical to the data exclusivity period for small molecules generic drugs outlined in the Hatch Waxman Act). What this means—based on the Obama Administration's proposal—is that a follow-on biologic manufacturer must wait seven years from the date of approval for the innovator (branded) drug before the US Food and Drug Administration could consider approval of a follow-on version of the molecule.

It is not surprising that the Obama Administration supports a 7 data exclusivity period--it is, after all, a compromise between the 5 year period sought by the follow-on manufacturers and the 12-14 years that the innovator companies are seeking. And, Mr Obama has repeatedly shown a willingness to compromise when it comes to getting important legislation passed. Hopefully, Congress will take the Obama Administration's compromise to heart and pass follow-on biologics legislation as quickly as possible.

 Until next time...

 Good Luck and Good Job Hunting!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

It seems that every day a new American industry asks the US government for a bailout because of impending financial exigency. That said, I was somewhat surprised to learn today that the biotechnology industry is planning to ask Congress for a bailout. The plan calls for Congress to temporarily changes tax laws to allow unprofitable biotech companies to get cash now, in exchange for tax credits that they would pledge not to take if they eventually become profitable. The companies that receive the cash would pledge that the money would be used ONLY for research and development activities. The reasoning behind the proposed government bailout is that the infused capital would allow struggling biotech companies to keep their current employees, stay in business and help to stimulate the US economy. It is not clear whether or not all biotechnology companies—publicly traded or privately held—would be eligible for the bailout package.

Currently, there are 327 publicly traded and roughly 1,000 privately held biotechnology companies in the US. A majority of these companies are not profitable and operate almost exclusively on institutional and private venture capital funds. According to the Biotechnology Industry Organization (BIO), 125 of 327 public companies currently have less than 6 months of cash on hand—nearly double the total last year. It is not surprising that the biotechnology industry like most other US industries is struggling and feeling the impact of recent financial meltdown—there simply isn’t enough liquidity in the system to keep all companies afloat. While I am not opposed in principle to government bailouts, there are several reasons why the proposed rescue plan for the biotechnology industry doesn’t sense to me.

First, unlike the automobile industry which employs millions of workers, the biotechnology industry only employs about 200,000 workers, many of whom have advanced degrees and possess specialized technical skills. And, studies show that during recessionary periods workers with specialized skills are more likely to find employment after losing a job than their unskilled counterparts. This suggest that it may be better for the American economy in the long run if the government bails out the auto industry before it even considers a bailout for biotech. Nevertheless, BIO is actively lobbying for a government bailout because it believes that a bailout will not only stimulate the American economy but also help to “preserve American innovation and competitiveness.” Of interest, the pharmaceutical industry which shed over 123,000 jobs in the last year or so is not asking for government assistance. As one Washington lobbyist aptly quipped after hearing about the proposed biotech bailout: saving “research-based companies that employ 30 people won’t necessarily stimulate the economy.”

Second, the biotechnology business is inherently a very risky one. The failure rate among biotech companies is roughly 90%. And, as many of you know, biotechnology companies are always started with venture capital from investors who are willing to invest in risky projects because of possible financially-lucrative returns. Because of this, biotechnology executives are generally beholden to their investors rather than their shareholders, stakeholders or employees. Unfortunately, important business decisions are frequently made at venture-backed biotech companies for financial reasons rather than scientific or medical ones. Further, many financially-challenged, biotechnology companies that would benefit from the bail out started up almost a decade ago when venture capital was abundant and IPOs were daily events. In retrospect, many of these companies shouldn’t have been started in the first place because their technology platforms were either inadequately vetted or their business models were fundamentally flawed. I believe that these financially troubled companies ought to be allowed to fail just like the technology companies that had to close down in the early 2000s after the Internet bubble finally burst.

Third, why should unprofitable companies without products or revenues be bailed out and rewarded for failure? As I posited in a previous post, a company really isn’t a business until it has a product, generates revenues and turns a profit (or at least break even). If a company cannot create a viable business after 5-10 years of capital investments then it wasn’t a good value proposition at the outset. Perhaps a better use of the proposed bailout money would be for the US government to create public funding vehicles for companies that have developed promising new drugs that already have proof of concept in humans and are ready for clinical testing.

Finally, over the past decade, the biotechnology industry has spent hundreds of millions of dollars lobbying against the reimportation of drugs from foreign companies and the development of so-called follow-on biologics (potentially cheaper versions of blockbuster biotechnology drugs that have lost patent protection). This decade-long lobbying effort was undertaken to preserve America’s biotechnology monopoly and to insure that biotech drug prices remain high. Maybe BIO and its member companies should have considered using some of those monies to help struggling biotechnology companies rather than using it to influence politicians for tax breaks and pork barrel legislative initiatives.

Lastly and perhaps most importantly, why should taxpayer dollars be used to bailout an industry that has actively opposed and steadfastly refused to provide ALL Americans with access to reasonably priced, potentially life-saving biotech drugs? Because the biotechnology industry isn’t fundamentally different than any other American industry, I believe that the Darwinian principle of “survival of the fittest ought” to be applied to it. Unless, of course, you work on Wall Street or in Detroit—but don’t get me started!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

At its annual business briefing, Merck’s CEO, Richard Clark, announced that the company is creating a new division called BioVentures that will develop and sell follow on biologics. Clark said that the reason for this surprising decision was based on “the arrival of the Obama administration and renewed enthusiasm on Capitol Hill for legislation that could create an easier path for generic biotech medicines.”

Merck’s new BioVentures division will be built around the humanized yeast manufacturing platform developed by Glycofi, a privately-held, company that Merck acquired two years ago. While most of big pharma and big biotech publicly lobbied against new legislation that would make follow-on biologics legal in the US, Merck was surprisingly low key on the subject (now, we know why).

I first learned about Glycofi’s technology platform shortly after the company was formed in the early 2000 and immediately recognized its implication for follow-on biologics manufacturers. I immediately contacted Glycofi’s CEO at the time to see whether or not they would hire me as a “follow-on biologics consultant.” Sadly, because cash was tight (as it always is at start ups) I didn’t get the gig but I did get to know Tillman Gerngross, one of the Glycofi’s founders and its Chief Scientific Officer. Tillman and I spent some down time together at many of the follow-on biologics conferences that I organized where he was an invited speaker.

I was glad (mostly for Tillman) when I learned that Merck was going to by Glycofi for $400 million in cash. That said, the acquisition didn’t make sense to me at the time because Merck didn’t have a biologics division (although it did have a successful vaccine division).  After today’s announcement, Merck’s decision to purchase Glycofi makes perfect scientific and financial sense to me. I wish I could have gotten a piece of Glycofi before Merck bought the company. Nevertheless, I take solace in the fact that I, like Merck’s executives, can recognize a winning technology when I see one!

Maybe Merck will turn itself around after all!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

The Pharmalot blog reported today that this coming Friday, the US Federal Trade Commission (FTC) will conduct a workshop on the issue of follow-on biologics. The roundtable will apparently be organized into five panels to discuss: 1) the price and market share effect of entry by both biosimilar and biogeneric drugs, 2) the likely competitive effects of reference product regulatory exclusivity, 3) biotechnology patent issues, 4) the likely competitive effects of follow-on biologic regulatory incentives, and 5) the patent resolution process.

The first thing that comes to mind is “beating a dead horse” (euphemistically of course). Call me crazy but these very issues have been bandied about and discussed ad nauseum and  for the past decade or so. I am not sure what new revelations will come to light at this Friday’s FTC roundtable meeting. 

Here’s a thought. Maybe industry representatives, FDA regulators and the insurance companies ought to ask the European Union how they were able to craft their version of a regulatory pathway for approval of these products way back in 2004. Nah…let’s let the lobbyist duke it out and see which side wins!

Until next time…

Good Luck and Good Job Hunting

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Just when I thought the absurdities surrounding the American follow-on biologics debate couldn’t get any sillier, the US Federal Trade Commission (FTC) announced today that it would sponsor public workshops and round table discussion to learn more about the impact of follow-on biologics on American competitiveness, regulatory policies and healthcare costs.

I am not certain what role the FTC has in the follow-on biologics debate (as far as I am concerned, it shouldn’t have much of one) but what new information does the FTC think that it is going to get that other more relevant government agencies like FDA or the US Congress don’t already have about follow-on biologics? After all, the debate to formulate an approval pathway for follow-on biologics in the US has gone on for almost 10 years now. How ineffectual and ineffective can the US government and its agencies be (rhetorical question)?

As far as I can ascertain, the main reason why follow-on biologics are not already being sold in the US are the never-ending efforts of power, well-funded lobby organizations like BIO and PhRMA. The data are incontrovertible: 1) the cost of branded drugs is out of reach for many Americans, 2) access to potentially life-saving drugs and treatments is hindered by restrictive drug formularies and onerous insurance co-pays and 3) many local and state governments and large, multi-national corporations can no longer provide adequate healthcare coverage for their employees because of out-of-control medical costs and expenditures.

In my opinion, the irony of the US follow-on biologics brouhaha is that it is putting American companies at a competitive disadvantage in the biosimilar/follow-on biologics space. Selling profitable, cheaper generic versions of blockbuster drugs is no longer a dream but a reality in countries like China and India whose middle class has finally come of age. True, the American pharmaceutical/biotech market is still the largest in the world—but will it still be the largest 10 years from now? Only time (and Asia) will tell.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

A post today on the Pharmalot blog suggests that Israeli generic manufacturer Teva is in talks to acquire US-based Barr Pharmaceuticals for  $7.0 -7.5$ billion. Barr’s present market cap is approximately $5.0 billion.

The acquisition would make sense for Teva to broaden its reach into the generic and branded generic markets in the US. Also, Barr recently acquired PLIVA which has active research programs on biosimilars and is currently selling its version of EPO in Croatia and other parts of Eastern Europe.

Teva has been trying to get into the biosimilar/follow-on biologics market for the past eight years or so. The company previously bought several early stage biogenerics manufacturers but have yet to advance their plans to formally enter the biosimilar/follow-on biologics market. This may be the opportunity that Teva has been looking for!

Check back for updates.

Until next time…

Good Luck and Good Job Hunting!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Richmond Va-based INSMED, a US-based follow-on biologics manufacturer, posted a press release on its website entitled: “Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company” that reports on the results from a Phase I clinical trial that demonstrated that it lead product INS-19 was bioequivalent to Amgen’s Neupogen^(R) (recombinant G-CSF) in stimulating human white blood cell production. 

, Dr. Geoffrey Allan, President and CEO of Insmed said  "These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. “ The company has requested a meeting with FDA to discuss the design of a Phase III human clinical trial for INS-19.

I am not sure why INSMED is so excited about its results. Sandoz essentially accomplished the same feat with Omnitrope, its biosimilar version of recombinant human growth hormone (HGH)and it took a law suit and a loophole in the approval process for growth hormones for FDA to allow it to be sold in the US. In my opinion, until legislation is passed that provides a clearly defined legal pathway for approval of follow-on biologics I suspect that INS-19 will suffer the same fate (or perhaps worse) than Omnitrope. Bioequivalence is only legal defined for and relevant for approval of small molecule NOT BIOLOGICS when seeking expedited approval for generic versions of branded products. That said, I want to tip my hat to INSMED for its willingness to take a lead role in the fight to get follow-on biologics approved in the US. Finally, there is nothing like an edgy press release and a few bloggers to bring an issue that is rapidly losing momentum back to the forefront.

Kudos to INSMED!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Just when you thought the obvious couldn’t be anymore obvious to US lawmakers, the Congressional Budget Office (CBO) today released a long-awaited assessment of the cost of a biogenerics bill and found that the legislation, if enacted, would reduce total expenditures on biologics in the US by $25 billion over the next decade—duh!!!  

According to a post over at Pharmalot, “The report comes as a growing group of drugmakers, insurers and employers agitate over the high cost of biologics, which may only be rectified if Congress passes legislation that would give the FDA guidance on creating a so-called pathway to approve biogenerics, or follow-on biologics. Two House bills have been proposed that are similar to the Senate bill reviewed by the CBO, although the looming summer recess and election-year politics suggest passage may not occur this year.”

Unfortunately, as I suggested in a previous post, the bills currently under consideration are flawed and would give unwarranted patent exclusivity to innovator companies if enacted. Nevertheless, as Kathleen Jaeger, head of the GPHA (a generic manufacturing trade group) aptly stated “We are still reviewing the analysis, but we are pleased that CBO agrees that significant savings will be achieved by bringing biogeneric medicines to consumers and that even greater savings will result from removing harmful barriers to access, including brand evergreening and unprecedented market exclusivity provisions. With Americans growing increasingly concerned about health care costs, we should be increasing access to affordable medicines while fostering competition in the pharmaceutical marketplace. “

By the time that a US approval pathway for biogenerics is divined, European and Asian biogeneric manufacturers will already control the market and the “new” (what took you so long) American legislation will provide little financial incentive for US companies to enter the biogenerics market space.

Until next time…

Good Luck and Good Job Hunting!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). The remaining three are “knock off” versions of erythropoietin alpha–Binocrit (Sandoz), Epoetin alpha Hexal (Hexal) and Abseamed (Medice Arneimittel Putter).

There is no doubt, at this point, that Europe is leading the way in the biosimilar space. However, it is important to point out that a variety of biosimilars, developed by Indian generic manufacturers and others, are already being sold in less- regulated Asian markets (see Table 1). Unfortunately, political issues and the fierce struggle between innovator

Table 1. Biosimilar Manufacturers and Their Products

biotechnology companies and generic manufacturers have delayed development of legislation for regulatory approval of follow-on biologics (American lingo for biosimilars) in the US. Further, and perhaps more perplexing, the FDA has been reluctant to issue any guidance on the topic. However, rising drug costs and increasing expenditures on biologics (both by Medicare and private insurers) have left American lawmakers with no choice but to craft legislation for approval of follow-on biologics.

In the first half of 2007 alone, three different bills were proposed to craft a statutory pathway for the approval of follow-on biologics under the Biologic License Application (BLA). The first of these bills–The Access to Life-Saving Medicine Act– was introduced into Congress by Representative Henry Waxman (CA) and into Senate by Senator Chuck Schumer (NY) in February. The second bill–the Patent Protection and Innovative Biologic Medicine Act –was introduced in Congress in April by Representative Jay Inslee (WA). Neither bill made any progress. This is because the Access to Life-Saving Medicine Act was considered to be heavily pro-follow-on whereas the Patent Protection and Innovative Biologic Medicine Act was deemed to favor innovator companies and did not provide any financial incentives for follow-on manufacturers.

A compromise was reached by both Republican and Democrat Senators and the Biologics Price Protection and Innovation Act was approved by the Senate on June 27.  It proposes 12 years of market exclusivity for the patent holders but also one year of exclusivity to the first follow-on biologic to be approved as interchangeable with the reference product.  I previously aired my views on the proposed legislation. For a more in depth analysis of the issues and the bills, please read this.

Recently, there was an important new regulatory development in the European biosimilar landscape. Sandoz’s EPO, Binocrit, received the same nonproprietary name (INN) as Amgen’s original erythropoietin alpha (Epogen in the US, Eprex in Europe).This was a big win for the biosimilar industry because the INN debate had been raging in the EU for the past several years. Innovator companies wanted biosimilars to have different INN than their products whereas biosimilar manufacturers were lobbying for identical INN designation. An identical INN designation allows for  interchangeability of medicines. The fact that EMEA granted Binocrit the same INN number as Eprex, means that the agency views the two products as biologically-equivalent and interchangeable. This paves the way for EU pharmacists to freely substitute Binocrit for the more expensive Eprex. Also, it sends a message to US lawmakers and FDA that the EU considers certain biosimilars as interchangeable with their innovator counterparts. As you may have guessed, the issue of interchangeability is being hotly debated and contested by advocates on both sides of the follow-on biologics fence.

The US is clearly dragging its feet in the follow-on biologics arena. The prime driver of this inertia is the imagined loss of revenue that many innovator companies fear will occur if the US ultimately divines a regulatory approval pathway for follow-on biologics. That said, with Europe and India leading the charge into Asia, it looks as though the US is going to loss a substantial amount of money (not to mention market share) anyway.

With regard to biosimilars in the US, it is no longer a question of “if” but “when.” That said, I think that the one seminal issue that needs to be addressed is what to call these things in the US?  In my opinion, the European moniker, biosimilar, is particularly apt and appropriate for this new class of medicines. Unfortunately, we Americans don’t like to play second fiddle to anybody, especially the Europeans. With this in mind, I have no doubt that they WILL NOT be called biosimilars in the US. Whatever they are called, don’t be surprised to find them your pharmacist’s shelves in the next couple f years!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

About five years ago, a friend of mine and I had an idea to form a non-profit dedicated to providing consumers with information regarding the safety of marketed pharmaceutical and biotechnology medicines.  At the time, we observed that consumers were repeatedly being misinformed about the safety and efficacy of many products, most notably follow-on biologics aka biogenerics. Unfortunately, we could not garner enough interest or financial support to get the organization off the ground. I guess that  we had a good idea, but, as usual, were a little ahead of our time. A new organization called The Coalition for a Competitive Pharmaceutical Market has recently set up shop with the same concept in mind.

Members of the coalition include insurance companies (Aetna, Humana, United Health Care and Blue Cross Blue Shield), pharmacies and drug distributors (CVS, Medco, Express Scripts, Rite Aid and Wallgreens), generic manufacturers (Barr Laboratories, Hospira, Teva, Mylan Laboratories and Watson Pharmaceuticals) and a large roster of Fortune 500 companies including General Motors, Ford, Caterpillar, Chrysler, Dow and Eastman Kodak. Think of the lobbying power–how cool is that?

I guess the time has come for rational drug pricing for the US. Big pharma and biotech beware–a nationalized healthcare system may not be far behind!

Until next time….

Good Luck and Good Job Hunting!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the FDA to the punch and issued draft guidance for follow-on biologics known in Canada as subsequent entry biologics. The Canadian regulatory agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway.

If approved, a subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly- available safety and efficacy data. Product interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A meeting to review the draft document is scheduled for May. The proposed Canadian legislation is very similar to that adopted by the European Union for biosimilar products (what they are called in Europe). Not surprisingly the recently proposed US legislation is markedly different than the Canadian and European legislation. Go figure!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Despite what the American public has been led to believe, the scientific, regulatory and safety issues related to biogenerics aka follow-on biologics, biosimilars, or subsequent entry biologics have been clearly investigated and are no longer controversial issues. All of the aforementioned "issues" have been analyzed and carefully vetted. This allowed EMEA, the European Medicines Agency in 2006 to craft a comprehensive regulatory approval pathway for biosimilars. For those of you who may not know, several biosimilar products are currently are the market and sold in all European Union member states. This begs the question–what is taking the US so long?

From the beginning, big pharma and big biotech have unequivocally and steadfastly opposed any legislation that would allow biogenerics to be approved and sold in the US. The trade groups BIO and PhRMA have literally spent millions of dollars lobbying members of Congress to oppose any legislation that would allow approval of biogenerics in the US. Now, in a sudden and unprecedented about face, big biotech and pharma have thrown their collective weight behind proposed biogenerics legislation that will be introduced in the near future by Representative Anna Eshoo (D-CA).

As far as I can tell, the primary reason for this sea change is the market exclusivity that may be afforded to innovator companies by the legislation. A quick perusal of the bill reveals that innovator companies will be granted 12-year market exclusivity for a product after its initial licensure. Further, under certain circumstances, this period of market exclusivity for an innovator product may be extended to 14.5 years. Also, reference product sponsors (innovator companies), as well as interested third parties (most notably universities) that own patents on the reference product may sue a biogeneric applicant for patent infringement. Under certain circumstances, such litigation could delay or prevent approval of the biogeneric product.

So what does the proposed legislation mean for biogeneric manufacturers seeking regulatory approval for their products in the US?  Unfortunately, it means that a biogeneric product application may not be approved or made effective until 12 to14 years after the original date of licensure of the innovator (reference) product. It also opens the door for patent litigation against biogeneric manufacturers to hinder or delay approval of their products. In my opinion, the proposed legislation is extremely one-sided and biased toward innovator companies. More importantly, it seems to me that the real intent of the legislation is to discourage (rather than encourage) biogeneric manufacturers from seeking US approval for their products, i.e. there are no real financial incentives or inducements for these manufacturers to seek approval because of the excessively-long market exclusivity period for innovator products.

On the surface, the proposed legislation would appear to be a long sought victory for biogeneric advocates and the American public which would benefit from less costly versions of potentially life-saving biotechnology drugs. That said, it seems to me that the proposed legislation is nothing more than a disingenuous attempt by big biotech and pharma to placate biogeneric advocates and the American public. In reality, the legislation provides innovators companies with a legally-binding regulatory approval pathway that will allow them to maintain or extend their monopolistic stranglehold on blockbuster biotechnology products. I think that the US Congress can do better when it comes to biogeneric legislation–the American public not only deserves it but demands it!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks (5)
• Share Link

Insmed a small, Richmond Va-based biotechnology and manufacturing company has upped the ante in the fight to bring follow-on biologics to America.  After spending some time on Capitol Hill, company executives  found that “people in Washington, as well as payors and patients don’t have an understanding at a reasonable level of the debate that is going on and the issues” surrounding that follow-on biologics debate. To reach as wide an audience as possible and frame the debate on the issues” the company decided to use the Internet to take the initiative to the next level–the Internet.

A key to Insmed’s initiative is an economic study on the potential savings follow-on biologics could provide to patients, payors and healthcare providers. The study is still being conducted and its results will be published on the net when available. The campaign also includes advocacy components that like user-generated content (blogs) and social networking sites. Recently, Insmed posted a video clip on YouTube that feature one of its scientists extolling the virtues and cost-saving advantages of follow-on biologics.

As many of you may know, I have long been an advocate of legislation to allow the approval and sale of follow-on biologics in the US.  Unfortunately, until now, only one side of the debate–from big biotech and BIO–has been heard by the American public. This has largely been due to marketing muscle and deep pockets of big biotech coupled with a lack of unity among follow-on biologics advocates. Web 2.0 with its social networks, blogs and video sites allows people with the smallest voices to be heard. And, sometimes those small voices can turn into  roars!

Kudos to Insmed for having the courage to boldly go where no generics manufacturer has gone before–on YouTube! Yeah baby!!!

Until next time….

Good Luck and Good Job Hunting (see you on Web 2.0)!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for follow-on biologics.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said "BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood added that "The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session." This is quite a policy turnaround for BIO which over the past 8 years has spent tens of millions or more lobbying against allowing follow-on biologics in the US.

Even more shocking than the BIO turn around, was the first ever plea last week by the Whitehouse to pass legislation to craft legislation to create a regulatory approval pathway for follow-on biologics-what’s up with that? I guess Bush and his big biotech buddies finally realized that large sums of money can be made in the follow-on biologics/biogenerics business. This possibility was not lost on the Europeans, who created a regulatory pathway for approval of biosimilars (what follow-on biologics are called in Europe) several years ago! Biosimilars are already on the European market–who said that Europeans were less entrepreneurial than Americans?

Contrary to statements made by FDA officials last week, which suggested that FDA would craft the follow-on biologics legislation, it now appears that FDA will  work closely with Congress to draft a legislative proposal for approval of  follow-on biologics. I don’t think that Congress’s involvement is a good idea given the political wrangling, deal-making and concessions that must be made in order to get legislation passed. As the old adage goes, something is better than nothing.

It looks as though follow-on biologics may become a reality in the US. As I mentioned in previous posts, I don’t think Americans will see follow-on biologics on the market before 2010 or 2011. That said, it gives us Americans something to look forward to!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The US Congress is poised this week to pass a new healthcare bill that gives the Food and Drug Administration (FDA) more authority to scrutinize drugs after they reach the market, including power to mandate label changes that warn of new risks. This is good news!

The bad news is that follow-on biologics advocates were unable to add legislation to the bill that would allow the FDA to approve follow-on biologics for sale in the US. As many of you may know, there is no legally sanctioned pathway for approval of generic versions of protein-based biotechnology drugs in the US. In stark contrast, the European Medicines Agency (EMEA) crafted legislation in 2006 to allow these products to be approved and sold in Europe. Since that time, several biosimilar drugs (the European name for follow-on biologics) have received marketing authorization by European regulators and are currently marketed in many countries in Europe and elsewhere.

Biotechnology drugs are typically very expensive and out of reach for many people who lack adequate healthcare insurance. Follow-on biologics advocates argue that their products can be sold at lower prices –anywhere from 25%-30% less – than their branded drug counterparts. The lower prices of biosimilar products that are currently sold in the EU tend to support this assertion.

Learn about Hispanic Recruiting at LatPro.com.

• Email This
• Print
• Comments
• Trackbacks
• Share Link