As Expected: the Debate Over Follow-on Biologics Legislation Hinges on Data Exclusivity

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!!!!!!!!

 

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Update: Chinese Researchers Finish Sequencing the Giant Panda Genome

China's Beijing Genomics Institute in Shenzhen announced that it has mapped the entire genetic code for the giant panda using DNA sequencing and analysis equipment from San Diego-based Illumina. The project began in mid 2008 and was completed by Jan.2009.

The panda at the center of this discovery is Jingjing, who lives in China's Chengdu Panda Breeding Research Center and was the mascot for the 2008 Beijing Olympics. The genetic information from Jingjing is expected to be complemented in the future with genetic information from other pandas.

Scientists hope to use the data from the sequencing project to better understand panda biology and reproduction. Giant pandas are difficult to breed in captivity and are currently on the endangered species list.

In China, the panda's genome sequencing was ranked by the Chinese government as one of the top 10 technology achievements of the year, right up there with the nation's space shuttle and the completion of the Tibetan railway.

Until next time...

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

 

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Some Revealing Pharma Factoids

From time to time, I come across some interesting facts and statistics that are worth noting. This month’s issue of Pharmaceutical Technology Europe offered several things that were blog-worthy. Here they are: 

  • IMS Health has readjusted the growth of the pharmaceutical industry in 2009 from 4.5-5.5% to 2.5-3.6% with sales expected to exceed $820 billion
  • The size of the US pharmaceutical market is expected to contract by 1-2% in 2009
  • Emerging markets like China, India and Brazil are expected to contribute to more than half of the global market growth in 2009 and sustain an average growth rate of 40% by 2013
  • The size of the Middle East pharmaceutical market is predicted to exceed $18 billion by 2014

As one industry analyst put it “This high level of growth in emerging markets, combined with the contraction of the US market and ongoing low single-digit growth in other developed markets, is driving the pharmaceutical market to a new world order.” If I had money, I would be investing in generic pharmaceutical companies and follow-on biologic manufacturers!

Until next time...

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

 

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Mom's Chicken Soup is Good for Pandas Too!!!!

The New York Times reported today that the Wuhan Zoo in Central China has taken to feeding its two 3-year-old pandas homemade chicken soup to reduce stress and provide them with a “nutritional boost.” Xiwang and Weiwei needed a boost after China’s weeklong National Day celebration. As many as 30,000 visitors swarmed the zoo this past Wednesday and over 1000 people packed into panda enclosure to see them. This caused the pandas to pace restlessly and zoo officials decided that it would be good to give them some chicken soup because they were “fatigued and had a bit of a shock.” Their normal diet consists mainly of bamboo, milk and buns.

The pandas apparently love chicken zoo and according to the zoo “They drink it like they drink their milk.” That said who can resist a steaming hot bowl of mom’s chicken soup when feeling ill or when things just aren’t going well? Personally, I like matzo balls in my chicken soup—but that is a different story!

Until next time….

Good Luck and Have a Cup of Chicken Soup on Me!!!!!

 

The Thing about Gardasil

The Pharmalot blog reported today that Merck received approval from the US Food and Drug Administration to use Gardasil to prevent vaginal and vulval cancer in addition to cervical cancer.

Of late, Gardasil has been a lightening rod for controversy—mostly because of Merck’s unrelenting marketing campaigns (and the behind-the-scenes lobbying for the vaccine to be placed on the US mandatory vaccination list)  coupled with the Christian right’s moral machinations about premarital sex and sexually transmitted diseases in general. Also, let’s not forget the brouhaha surrounding FDA’s decision to delay approval of GlaxoSmithKline’s competing cervical cancer vaccine called Cervarix. Finally, about a month ago, there was study published in the New England Journal of Medicine questioning the cost effectiveness of Gardasil vaccination of women after the age of 18.

Regardless of your moral, ethical or business concerns about Gardasil, the bottom line is this: girls/women vaccinated with Gardasil are much less likely to develop cervical cancer as compared with those who are not vaccinated.

As I have mentioned before, all approved and marketed drugs have side effects and possible safety/tolerability issues. More importantly, the decision to approve a particular drug is always based on a careful risks/benefits assessment by government healthcare regulators. Whether or not a person uses a drug or vaccine is ultimately a personal choice. With the exception of mandatory childhood vaccines (children can be exempted for moral or religious reasons), every American has the right to decide whether or not to use a medication or undergo a treatment recommend by a healthcare professional. Based on everything that I have read about Gardasil, it appears to be a safe and effective vaccine to prevent cervical cancer. When FDA finally approves Cervarix (probably sometime in late 2009), it will offer women who may have concerns about Gardasil with an alternate vaccine to protect them against developing cervical cancer.

The funny thing about the Gardasil firestorm is that cervical cancer isn’t a major healthcare problem in the US. This is because a majority of American women undergo annual routine gynecological examinations (that include pap smears, the current gold standard for cervical cancer detection). In contrast, cervical cancer is a major healthcare problem and economic concern in Asia, most notably in China and India. This begs the question—why are Merck and GSK so intent on selling their cervical cancer vaccines in the US? Put simply, there is still much more money to be made in the US than in Asia. Look for approval of Gardasil and Cervarix in China and India when the middle class of both countries reach a critical mass.

Until next time…

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

Chinese Food and Your Heart

Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

Another Genzyme Story: Looking to China for Innovation

Genzyme announced today that it plans to build a research and development center in Beijing as part of its continued global expansion. When completed, the 200,000 square-foot facility (which is expected to cost $90 million to build) will be able to accommodate 350 employees.  The company, which wants to establish a long-term presence in China, expects the facility to open in 2010.

Genzyme said it already has 25 employees working in offices in Beijing and Shanghai and has a pilot program for its cell therapy MACI at Beijing Wujing Hospital. Like other American biotechnology companies, Genzyme see a bright future in China. 

And since I am talking about China, I would be remiss if I didn’t mention that I will be in China in about three weeks to visit my friend who is an executive chef and will be managing food operations at the Beijing Olympics in August, 2008. I plan on visiting Beijing and Shanghai, so if you live in either of these cities and want to get together to chat about biotechnology, blogging or anything else, please feel free to drop me a line.

Until next time….

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

Sequencing the Giant Panda Genome

Who can resist those adorable black and white Giant Pandas? Late last week, the International Giant Panda Genome Project was launched by Beijing Genomic Institute-Shenzhen, China. The goal of this project is to finish the sequencing and assembling of the draft sequence within six months. 

According to the news release:” The giant panda is a much loved animal all over the world and is considered a symbol of China, as illustrated by its being one of the mascots for the upcoming Olympics in Beijing. The excitement surrounding the launch of this ambitious project, however, has been built around how this new genomic information will have extensive impact in numerous scientific areas -- from ecology to evolution to sequencing technology. Such data will aid in understanding the genetic and biological underpinnings of this unique species, especially with regard to its very specific niche in the environment and the molecular mechanisms of its evolution.”

“Of special interest is that these data will be extremely useful for protecting and monitoring this endangered species and will provide information on the impact of captive breeding. In addition, it will have considerable use in controlling diseases that could devastate these fragile populations.” For those of you who don’t know, breeding pandas is not an easy thing. In fact, according to a guy I used to work with, who is a panda breeding expert, it is more art than science. However, it may not be as arcane as he makes it out to be considering that he had a sweet consulting gig for panda breeding with the Chinese government.

The giant panda project (GPP) will be conducted by Chinese scientists as well as scientist from other countries including, Canada, Wales, Denmark and the United States! It is truly an international collaboration!

Long live the pandas!

Until next time…

Good Luck and Good Job Hunting (try GPP- China)!!!!!!

Enough with the China Bashing Already

For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to Baxter’s heparin which has been associated with illnesses and deaths in this country.  

I suspect that this recent spate of China bashing has more to do with political and future economic issues than the safety and well being of the American public. Nevertheless, according to US Food and Drug Administration Current Good Manufacturing Practices (CGMP) regulations, companies that hold the licenses to manufacture pharmaceutical and biotechnology products assume full responsibility for the quality and safety of their products. To accomplish this, companies are required to test all raw materials, excipients and APIs (regardless of their source) before they are assembled to make a finish pharmaceutical or biotechnology product. The results of these tests must be carefully analyzed and compared with the product quality specifications established by the company and approved by FDA. If the test results for product ingredients are outside of the normal range of established specifications, then the company is obliged to reject the materials and not used them to manufacture product. To that end, there was clearly, something was wrong with quality testing at the Baxter heparin manufacturing facility because the adulterated heparin API should have been detected long, before it was used to manufacture the final product. Although the Chinese heparin may have adulterated, the onus was on Baxter (the company that holds the product license) and not the Chinese government to insure its final product met quality standards and was safe for public use.

Outsourcing is a fact of life in almost every sector of the American economy. Pharmaceutical and biotechnology companies import the materials they use in their products from all over the world. It is FDA’s job to insure that American companies remain CGMP compliant so that they produce safe and effective medications. To blame America’s regulatory shortcomings on foreign manufacturers and their governments is dangerous and naïve-not to mention chauvinistic.

Until next time…

Good Luck and Good Job Hunting (try Shanghai)!!!!!!!!!!