Now that the dust has settled, we thought it would be a good time to offer further perspective on the Amgen/Sandoz biosimilars decision, particularly since there has been much confusion and conflicting commentary on what this Supreme Court decision really means.

In April, the Supreme Court heard oral arguments from Amgen and Sandoz (the generic manufacturing arm of Novartis) regarding interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which establishes an alternate pathway for FDA approval of biologics.  See Sandoz Inc. v. Amgen Inc. (No. 15-1039, 15-1195).  Two key issues were raised:  whether a biosimilar manufacturer is (1) required to provide manufacturing information from their abbreviated biologics license application (aBLA) to the manufacturer of the original reference biologic (i.e., the reference product sponsor, or RPS) and (2) whether the biosimilar manufacturer can give the 180-day notice of intent to market the biosimilar (known as the Notice-of-Commercial Marketing) to the RPS prior to receiving FDA approval.  The second question is perhaps the more interesting and financially important.  If notice cannot be given prior to FDA approval, the RPS can potentially benefit from an additional period of market exclusivity because the generic would essentially not be able to market their product until 180 days after FDA approval.

Specific to this case, Sandoz’s Zarxio® (filgrastim-sndz) is a biosimilar version of Amgen’s reference biologic Neupogen® (filgrastim).  Sandoz failed to adhere to both of the above-mentioned BPCIA requirements, i.e. Sandoz failed to provide Amgen with their aBLA and Notice-of-Commercial Marketing for Zarxio.  In response, Amgen requested injunctions to enforce the BPCIA and then sued Sandoz for infringement.  Furthermore, regarding the 2nd requirement, Amgen argued that the 180-day waiting period should not begin until after FDA approval.  As mentioned above, this would in fact give Amgen a 6-month market advantage.  The Biosimilars Council commented on this point that “if every biologic is assured an extra six months of exclusivity, that shifts literally billions of dollars from patients, federal programs, and insurance premiums to biologic sponsors.”

On June 12, the Supreme Court ruled in favor of Sandoz, citing that the biosimilar manufacturer did not have to provide Amgen with its aBLA and could market Zarxio before FDA approval.  The outcome of this case will undoubtedly have a long-lasting impact on biosimilars and the interpretation of the BPCIA.

-David Puleo and Anthony D. Sabatelli, PhD, JD

David Puleo is a Ph.D. Candidate in the Pharmacology Department at Yale University. He is currently involved in two drug discovery projects targeting tyrosine kinases. Prior to attending Yale, David graduated from Boston College with a B.S. in Biochemistry, after which he worked for two years in the Center for Proteomic Chemistry at Novartis Institutes for BioMedical Research in Cambridge, MA.

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