As blockbuster drugs go off patent, the pharmaceutical industry is scrambling for fresh revenue sources. Follow-on versions of biologics, or “biosimilars,” are being pitched as BigPharma’s saving grace. One question remains unaddressed in the discussion: is anyone actually planning on selling biosimilars in the United States? [...]
According to [Parexel consultant Dr. Saurabh] Aggarwal, the FDA is already planning to require too much data for biosimilars to succeed in the US. “For biosimilars to be successful, the amount of data required from a regulatory standpoint cannot be as onerous as that required to get a pioneer biologic approved.” [...]
Given that the US biosimilar approval pathway as now imagined does not anticipate full interchangeability, is US biosimilar development doomed before it begins? According to Aggarwal, quite possibly. [...]
One reason that we are not doing the same might be that the large, influential companies here in the US still have major branded biologics in the pipeline. Hence, these bigger players are waiting and watching while they lobby to protect their branded interests, which are far more profitable at present than any risky foray into biosimilars. Current budgets for lobbying Capitol Hill on behalf of these companies’ branded biologics are equal or greater to their entire budgets for US biosimilar development.