Sandoz’s 2017 Trifecta in Biosimilar Battle with Amgen

With a couple of wins this month, Sandoz Inc. can boast that it beat Amgen Inc. in district court, the Federal Circuit, and the Supreme Court in a single year in a long-running battle over its filgrastim and pegfilgrastim biosimilar products.

The U.S. District Court for the Northern District of California ruled Dec. 19 Sandoz’s method for making and purifying filgrastim and pegfilgrastim, which are white blood cell boosters, does not infringe an Amgen patent.  Sandoz’s filgrastim biosimilar, Zarxio, is the first FDA-approved biosimilar, with Amgen’s Neupogen as the reference product.  Amgen’s longer-lasting Neulasta is the reference product for Sandoz’s yet-to-be approved pegfilgrastim biosimilar.

The U.S. Court of Appeals for the Federal Circuit ruled Dec. 14 the Biologics Price Competition and Innovation Act preempts state law and prevents biologic reference product holders like Amgen from relying on state remedies to force biosimilar applicants to participate in the BPCIA’s information disclosure “patent dance.”  Amgen had argued Sandoz violated California unfair-competition and conversion laws when it refused to dance.

And the Supreme Court ruled against Amgen as well June 12, holding that a biosimilar applicant does not need to wait until the FDA licenses its product before providing the BPCIA-required 180 days’ notice to reference product holders before marketing it. The court also held the BPCIA does not provide a federal remedy, such as obtaining an injunction, to force a biosimilar applicant to dance. (The court left it to the Federal Circuit to address whether state-law remedies were available, which led to Sandoz’s win there this month.)

While the district court win smooths the path for a specific Sandoz biosimilar effort, the appellate and high court triumphs in 2017 benefit biosimilar makers as a whole, providing them more options on how and when to address patent issues while bringing their products to market.

Read my story on the district court decision here.

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