On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and is expected to significantly impact the approval and patent litigation processes for biosimilar applications. First, the BPCIA requires a biosimilar applicant
Category Archives: Biosimilars Patent Exchange
Subscribe to Biosimilars Patent Exchange RSS FeedGuide to Recent Biosimilar Activity by FDA and in the Supreme Court
The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability. In parallel, litigation that should clarify the BPCIA patent resolution process, including timing of the
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FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for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).
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
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