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« House Subcommittee Holds Hearing on Follow-on Biologics | Main | Former House Economist Testifies at Follow-on Biologics Hearing »

July 15, 2009


Great article--I had not heard the Welbutrin story. It's discouraging that the FDA seems to want to turn a blind eye to any possible problems.

How are the bioequivalence parameters set for a particular drug? If it is notice and comment rulemaking by the FDA, perhaps patient advocacy groups could try to convince the FDA to set tighter limits. I would think that the AARP, for example, would be all over this, but when I hear about their activities it is all about how drugs cost too much (or how patents are bad).


Some very interesting observations about these biogeneric bills, including the issues with the existing FDA provisions on generics of conventional drugs. Anyone who thinks Hatch-Waxman can simply be reapplied without more to biogenerics is either ignorant, or just myopically focuses on these biogenerics as being a less expensive alternative without ever considering the significant (and serious) issues about the bioequivalency and even safety of these biogenerics. If there are significant (and serious) issues about the bioequivalency and safety of generics for conventional drugs, these issues go up almost exponentially with biogenerics.

Dear Pizarro:

Waiting until the geriatric equivalent of the Thalidomide tragedy occurs is, I'm afraid, the only sure way to get the attention of the Congress blinded as you say by lower drug costs (a huge budgetary issue for the federal government). With luck, the FDA will act appropriately.

Thanks for the comment.

For anyone interested in further reading on the issue of biosimilars, see the Stockholm Network's latest paper in its series on patient safety: Biogenerics or Biosimilars? Discussing the Present, Considering the Future.

In this paper, Rachel Chu and Dr Meir Pugatch explore the issue of biosimilars and their impact on healthcare policymaking. They examine the various challenges that the advent of biosimilars raises, particularly with regard to the regulatory framework, market opportunities, IPRs and most importantly of all, with regard to public safety.

The paper takes four of the most relevant pathways as case studies, namely the EU, WHO, Canada and the US (where legislation is still under way), and evaluates in particular whether these pathways have resolved the safety and IP dilemmas. Finally, it presents several policy recommendations, which should allow more clarity and predictability for those wishing to enter the market as well as providing enhanced scientific rigour, in the interests of patients.

To view the paper, please visit:

To view the executive summary, please visit:

These comments are VERY old--- since this was written, the FDA has removed Budeprion XL300 made by Teva from the market. Bupropion long acting is under review and must submit new tests by march.

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