Amgen Sues Hospira to Slow Marketing of Biosimilar

Amgen is hoping a Delaware judge will be more agreeable than a California court as it sues Hospira to slow the biosimilar maker from marketing its challenger to Epogen.

Amgen alleges Hospira failed to disclose information on the manufacturing process of its biosimilar version of Epogen (epoetin alfa) within 20 days of the FDA’s acceptance of its application for review. Hospira submitted its BLA to the FDA in December 2014, but notified Amgen on Feb. 23 that the BLA had been accepted.

Amgen filed a similar lawsuit in Northern California against Sandoz in 2014, making the same complaints in an attempt to delay the launch of its biosimilar Zarxio.

In its new lawsuit, Amgen says Hospira is also refusing to give at least 180 days’ notice of commercial marketing of the biosimilar, which must be provided after the date of FDA approval. It is asking the judge to determine the date when Hospira can begin selling its biosimilar.

Hospira will review the Amgen Inc. et al v. Hospira Inc. complaint and respond accordingly, company spokeswoman Neha Wadhwa said.

The lawsuit, filed last week in U.S. District Court in Delaware, is the second by Amgen to protect one of its products against a biosimilar.

In California, Amgen sought to delay Sandoz’ launch of Zarxio (filgrastim-sndz), a biosimilar of its chemotherapy drug Neupogen (filgrastim). A three-judge panel ruled in July to uphold the lower court’s ruling in Amgen Inc. v. Sandoz Inc. that allowed the Sept. 3 launch. — Jonathon Shacat