- Novartis' generics unit Sandoz is petitioning the Supreme Court to overturn an earlier decision by a federal appeals court over when a biosimilar drugmaker must notify a brand name manufacturer it plans to market a biosimilar.
- Under the Biologics Price Competition and Innovation Act (BPCIA), a company which wishes to sell a biosimilar version of a branded drug must give the original drugmaker 180 days of notice.
- When Sandoz won the right to market Zarxio, its biosimilar version of Amgen's Neupogen, it attempted to argue it could give Amgen notice 180 days before the FDA granted biosimilar approval. However, a federal appeals court ruled that Sandoz needed to wait until approval was granted before submitting notice to Amgen.
While the difference may seem small, if the federal appeals court ruling stands as a precedent for all biosimilar entrants, brand name companies will in effect be getting an additional six months to initiate patent challenges against the biosimilar entrant. Already, biologics are granted 12 years of data exclusivity.
In the appeals court case, Amgen pointed to BPCIA language which says a biosimilar entrant can only give notice of marketing after the FDA has licensed its product, as explained by the National Law Review. This would necessitate waiting until the FDA granted approval to a biosimilar.
Zarxio was the first biosimilar approved in the U.S., but the market is just beginning to develop with more companies (including Sandoz) planning to introduce biosimilar versions of branded drugs. It is uncertain whether the Supreme Court will take up the appeal, but, if it did, the ruling would have significant impact for pharma companies, biosimilar manufacturers, and consumers.