Biosimilar Battles Continue in District Court


Amgen Inc. and Mylan Inc. are continuing to battle it out over Mylan’s proposal to make a biosimilar version of Amgen’s blockbuster anti-infection biologic Neulasta even after the two companies already took their battle to court.

This time, Amgen is accusing Mylan of infringing two patents relating to processes for manufacturing Neulasta, a biologic to treat chemotherapy side effects, by submitting an application to the FDA in February to make a biosimilar version of the medicine.

The battle is likely to be hard-fought because the financial stakes are high for both companies: Neulasta brought in $4.6 billion in sales last year.

In the suit, filed Sept. 22 in the U.S. District Court for the Western District of Pennsylvania, Amgen claims Mylan’s proposed biosimilar infringes U.S. patents 8,273,707 and 9,643,997, both of which cover processes for purifying proteins used to manufacture biological products.

Thousand Oaks, Calif.-based Amgen is asking the court to keep Mylan from “piggybacking on the fruits of plaintiffs’ trailblazing efforts” by copying the product and is also seeking monetary damages.

Meanwhile, although there are multiple pending applications for biosimilar versions of Neulasta (pegfilgrastim) at the FDA, including Mylan’s, the Food and Drug Administration hasn’t yet approved any of them. In June, the agency rejected Coherus BioSciences Inc.’s abbreviated biologics license application for Neulasta, asking the company to reanalyze some existing data for the product.

Mylan N.V., the parent company of Mylan Inc., has its global headquarters and principal offices in Canonsburg, Pa., and its principal executive offices are located in Hertfordshire, England.

The case is Amgen Inc. v. Mylan Inc., W.D. Pa., No. 2:17-cv-01235, complaint filed 9/22/17.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.

Learn more about Bloomberg Law and sign up for a free trial.