Scientific American: Biosimilars Are Back… Or Are They?

RA Guy Community News 5 Comments

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.

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  2. Deb aka murphthesurf

    It’s about the money. Has been, will be, and unfortunately will not change until we get lobbyists out of Washington. Everything in the US is about money these past 10 years and it is truly a sin. And of course we won’t be able to buy from countries abroad if they have biosimilars because our FDA will find a way to block that as well. One would think that organizations like the Arthritis Foundation would be all over this in favor of their members…I will be watching with interest but suspect that won’t happen as they too are supported primarily by the large pharmecuticals. I am not targeting them specifically I am just saying that the interests of the patients/consumers is lost.

  3. Joie

    Currently 78% of prescriptions in the US are written for generics. With many blockbuster chemical-based drugs going off patent, drug companies will be looking to biologics to make their profits. Rather than investing in research and development, multinational drug companies have bought other companies for their biologics — Pfizer bought Wyeth, who markets enbrel.(1)

    Having RA, a chronic condition most likely requiring being on meds like biologics for the rest of my life, I worry about future affordability. Enbrel goes off patent in 2012, but with no competition from biosimilars, will the price of enbrel go down?


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