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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!!!!!!!!

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Earlier this week, Roche announced that it wanted to buy the remaining portion of Genentech that it doesn’t already own. On Friday, one of Europe’s largest pharmaceutical companies, Sanofi-Aventis, announced that it was buying the UK-based vaccine manufacturer Acambis for $547 billion.

Like Roche and Genentech, Sanofi-Aventis was already partnered with Acambis and by purchasing Acambis, Sanofi gains a smallpox vaccine that was contracted by the US government for $425 million. Sanofi is the world’s largest manufacturer of influenza vaccines and last month announced plans to open a $157 million manufacturing facility in France, citing projections that demand for vaccines will double by 2016. In case you didn’t know, vaccines, once the scourge of the pharmaceutical industry, are now the hottest”pharmaceutical” products on the market!

Because of growing demand and lucrative margins for biologics and biotechnology products, many big pharma companies are attempting (through acquisitions and mergers) to quickly enter the biologics and biotechnology markets. These days, small molecules are passé and biotech is the next big thing (where have all the pharma execs been for the past 20 years).  

Europe has long wanted to dominate the biotechnology market. This has not been possible because of the US’s large lead in the space. However, all this can change because of a weak dollar and a surging Euro! Rather than attempt to create their own biotechnology companies, large cash-rich, European pharma companies can simply buy profitable US biotechnology companies with strong product pipelines.

I suspect that the weak dollar and failing US economy contributed to Roche’s decision to buy Genentech and Teva to buy Barr Pharmaceuticals last week. I would not be surprised if there are more acquisitions of American biotechnology and pharma companies in the very near future. I think that it may be time for Amgen and Bristol-Myers Squibb employees to begin to brush up on their French or German.

Until next time….

Good Luck and Good Job Hunting (in Europe)!!!!!!!!

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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!!!!!!

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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!!!!!!

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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!!!!

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I have been following the pharmaceutical business for the past 20 years or so and without fail; Bristol-Myers Squibb has been rumored to be a takeover target. Well, here we go again!

 that floated the possibility that BMS is a prime takeover target again. Like many other financial pundits, Zachs believes that a takeover by Sanofi-Aventis makes the most sense. As many of you may know, BMS and Sanofi-Aventis co-own the multibillion dollar Plavix franchise (which will lose patent protection in 2011).

Rumors of a BMS takeover started in 1988 and they have always proved to be false. In my opinion, BMS has one of the stronger biologics pipeline in the pharmaceutical industry. Further, BMS is spending an enormous amount of time and resources to vigorously reinvent itself as a “next generation biopharma” company (whatever that means). The impending loss of Plavix revenues does put some pressure on the company’s ability to remain independent, but BMS has weathered many storms in the past (and lived to talk about them). That said, it is anybody’s guess whether the current rumors are real or imagined.

Until next time…

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

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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

Company	Launched Biosimilars	In the Pipeline
Barr                                                          (www.barr.com)	EPO scheduled for launch in Eastern Europe	G-CSF (Filgastrim), Insulin, and HGH
Biocon                                          (www.bioconinc.com)	Insugen (Insulin in India and China), Erypro (EPO) G-CSF, Nimotruzmab, BIOMAb EGFR (cancer)	Insulin, glargine and HGH
Biopartners                             (www.biopartners.ch)	Valtropin (rHGH)	Alpheon (INF-α) and EPO
Cipla                                                   (www.cipla.com)	None	Autoimmune, cancer and cardiovascular
Dr. Reddy’s Labs                       (www.drreddys.com)	G-CSF (Filgastrim)	Nine (9) development programs
Glenmark                  (www.glenmarkpharma.com)	None	GBR 500 (mAb for MS), GBR600 (antithrombotic) and mAbs for adhesion molecular inhibitors
Intas Biopharma (www.intasbiopharma.com)	Neukine (G-CSF), Erykine (EPO) and Intalfa (INF-alpha2b)	Six (6) development programs
Prolong Pharmaceuticals (www.prolongpharmaceuticals.com)	None	PEG-EPO and other PEGylated proteins
Ranbaxy (www.ranbaxy.com)	Nugraf (Filgrastim), Macrogen (Molgramostim from Zenotech)	mAbs in oncology and neurology
Sandoz (www.sandoz.com)	Omnitrope (HGH), Binocrit (EPO)	Six (6) development programs including G-CSF (Filgrastim)
Shanta Biotechnics                              (www.shantabio.com)	Shaferon (INF-alpha2b, Shankinase (streptokinase) and Shanpoietin (EPO)	mAbs and PEGylated therapeutic proteins
Stada                                               (www.stada.de)	EPO-Zeta (approved)	Filgrastim
Teva                                           (www.tevapharma.com)	G-CSF (Filagstrim),Teva-Tropin (HGH), INF-alpha2b	Insulin, EPO and interleukins
Wockhardt                             (www.wockhardt.com)	Wepo (EPO), Wosulin (insulin) INF-alpha2b, G-CSF	Insulin Glargine

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!!!!!!!!!

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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!!!!

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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!

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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 are no longer controversial issues. They have been identified, 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!!!!!!!!!!!

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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)!!!!!!!!

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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!!!!!!!!!!!

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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.

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Nevertheless, it is patently obvious to most folks (aside from biotechnology and pharmaceutical executives) that healthcare costs are spiraling out of control in the US and that the availability of potentially life-saving biotechnology drugs at reduced prices would help to contain some of these costs. Not surprisingly, the US biotechnology industry is staunchly opposed to the approval of follow-on biologics. Lobbyists who work for big biotech companies (and the Biotechnology Industry Organization) will tell you that their clients are opposed to follow-on biologics because there will likely be safety problems with these products (this has not been the case with biosimilars in Europe). In reality, the US biotechnology industry is opposed to follow-on biologics because introduction of these products at reduced prices will interfere with their ability to maintain monopolistic control of lucrative drug franchises which, in turn, would cut into corporate profits and negatively affect stock prices.

Over the past five years, I organized and attended many conferences on follow-on biologics/biosimilars. The question that Europeans, Asians and others always ask is: “When can we expect to see follow-on biologics on the market in the US”? The answer that I usually give is “Not any time soon”! Although we are slowly inching toward an approval process for follow-on products in the US, (some analysts are predicting that a compromise on follow-on biologics in US will occur sometime in 2008 or 2009), I still say “Not anytime soon”!

Until next time….

Good Luck and Good Job Hunting…..

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