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6-Month Notice from a Biosimilar Sponsor Always Required -- Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new abbreviated FDA licensure pathway for highly similar biological products called biosimilars (see here for our prior posts on biosimilars).  Yesterday, a three-judge panel of the Federal Circuit Court of Appeals issued a unanimous opinion interpreting the BPCIA's provision that requires biosimilar applicants to give reference product sponsors Notice of Commercial Marketing at least 180 days before market launch of the biosimilar.  The question presented was whether compliance with the so-called Patent Dance provisions of the BPCIA obviates the need for a biosimilar applicant to provide that 180-day notice.  The court stated clearly that the answer to that question is "No" and that notice of commercial marketing is always required after FDA's date of licensure for the biosimilar.  Our IP colleague Tom Wintner explains the importance of this Amgen Inc. v. Apotex Inc. Federal Circuit decision to the biosimilar industry here.

Here at Health Law & Policy Matters, we continue to monitor the impact of this BPCIA ruling on the biosimilar product pipeline, the wider drug pricing debate, and efforts in Congress to reduce the market exclusivity  period granted by the law to brand name biological products.

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.