The Cross-Border Biotech Blog

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Biotech Trends Update — Biosimilars: FDA Meeting in November to Discuss BCPI Act Implementation

Adam Feuerstein at TheStreet.com reported this morning on a draft FDA notice for a planned November meeting on implementation of the Biologics Price Competition and Innovation Act, which was passed as part of the healthcare reform legislation.

The BPCI Act (42 U.S.C. 262(k)(8)) provides for the FDA to author guidance “with respect to the licensure of a biological product” — pretty broad, so we’ll have to stay tuned for the actual meeting notice. However, the legislation provides some hint in permitting “product class-specific guidance” specifying criteria that will be used to determine whether a biological product is highly similar to a reference product in such product class.

If the FDA decides to move ahead with product class guidance, it would likely specify the criteria that will be used to determine whether a biological product meets the standards for “interchangeability”.

In other cases, the FDA may determine that “the science and experience [to date] … with respect to a product or product class … does not allow approval of a [biosimilar] for such product or product class.”

Bottom line: following the FDA’s November meetings, biosimilars will be one step closer in the U.S.

P.S. Adam Feuerstein cites Alec Vachon (@HEALTH_NOTES) on Twitter for breaking the story Friday. Not sure why I haven’t found him before, but Alec is now added to my Biopharma-IT-Health Twitter list.

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3 responses to “Biotech Trends Update — Biosimilars: FDA Meeting in November to Discuss BCPI Act Implementation

  1. Pingback: Biotech Trends Update — Biosimilars: FDA Meeting Formally Announced, EMA Working on Rules for (a few) Antibody Biosimilars | The Cross-Border Biotech Blog

  2. Ashritha (infoalcpl@gmail.com) October 7, 2010 at 8:24 am

    My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
    Various issues have been dealt with, such as:
    - Patent expirations
    - Regulatory frameworks
    - Infrastructure Requirements
    - Etc.
    If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.

  3. Pingback: EMA Working on Rules for (a few) Antibody Biosimilars « The RIC Blog

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