The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Biologics Price Competition and Innovation Act

Approval Pathway for Biosimilars and Interchangeable Biological Products: Issues from the FDA’s Public Hearing

On November 2nd and 3rd the FDA held a public hearing to address the challenges it will face in the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This act established an abbreviated pathway for follow-on biologics (a.k.a. biosimilars) that are either “highly similar” or “interchangeable” with previously approved biologics. Many industry stakeholders were in attendance to voice their opinion on the matter including Pfizer, Roche, Merck, Novo Nordisk, Novartis, Amgen, Shire, and TEVA, amongst others. I tuned into these webcasts to extract the salient areas of debate. Read more of this post

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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