Amgen Sues Pfizer, Hospira in Neulasta Patent Dispute
Amgen called for a jury trial for Hospira in the U.S. District Court for the District of Delaware, alleging that the Pfizer subsidiary’s proposed Neulasta (pegfilgrastim) biosimilar infringed on its patents for the anti-infection drug.
Neulasta is approved by the FDA to decrease the chance of infection in patients taking myelosuppressive anti-cancer drugs. The blockbuster drug earned $2.8 billion in fiscal 2019, a 28 percent drop from the previous year attributed to biosimilar competition.
Amgen claims Hospira and Pfizer infringed upon its ‘707 patent for the drug when they submitted an abbreviated BLA (aBLA) for their proposed pegfilgrastim biosimilar before Amgen’s patent expired. That BLA was accepted for FDA review in August 2019.
Amgen filed the suit following a “patent dance” with Hospira, in which the biosimilar applicant and the reference product sponsor failed to resolve potential patent disputes.