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Biosimilars Law Blog

Category Archives: Biosimilars Patent Exchange

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Posted in Biosimilars Patent Exchange, News & Events

FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings

FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for moving protein products currently approved under the drug statute (section 505 of the Food, Drug and Cosmetic Act) to the biologics system (section 351 of the Public Health Service Act).

Posted in Biosimilars Patent Exchange, News & Events

Universities urge FDA to require certification of information exchange for biosimilar applications

A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the information exchange and patent dispute resolution provisions of the BPCIA.  The concern raised is that: “biosmilar sponsors can effectively circumvent every patent litigation provision of the statute simply

Posted in Biosimilars Patent Exchange, Biosimilars vs. Generics

If you missed the Maximizing Patent Life Cycles panel discussion, you may want to read this

I recently participated in the American Conference Institute panel discussion “Maximizing Patent Life Cycles,” which was moderated by Pfizer Associate General Counsel Geoffrey Levitt. In case you missed it, “The Pink Sheet” covered the event in its article “FDA Denies Veramyst NCE Exclusivity, Revokes Torisel Exclusivity,” which expands upon several recent decisions from FDA on