Amgen, Pfizer’s Hospira Settle Neulasta Cancer Drug Patent Suit

Amgen Inc. and Pfizer Inc.'s Hospira settled a patent-infringement lawsuit over Hospira’s proposed biosimilar version of Neulasta, the blockbuster cancer treatment that had U.S. sales of more than $1.5 billion in 2021.

No details of the settlement were made available in the agreement, which Judge Colm F. Connolly approved Monday in the U.S. District Court for the District of Delaware.

Amgen filed the suit in February 2020, seeking royalties from sales of Hospira’s cheaper version for allegedly infringing a patent that covers a process for purifying proteins that Bloomberg Law estimates will expire in September 2024.

Biosimilars are nearly identical versions of branded biological drugs and are made from living organisms. Neulasta, which launched in 2002, stimulates the production of white blood cells to counteract the deficiency caused by chemotherapy, boost the patient’s immune system, and lower the risk of infection.

Amgen and Hospira settled a related case last September over Hospira’s proposed biosimilar version of Neupogen, a white blood cell booster that has been on the market since 1991.

Four biosimilar versions of Neulasta are now on sale in the U.S., Amgen said Feb. 7 in its annual earnings report, “and we expect other biosimilar versions of Neulasta to receive approval in 2022 and beyond.”

“Impact to our Neulasta sales has accelerated as additional competitors have launched,” Amgen said in the report.

Neulasta’s U.S. sales in 2021 were 24% lower than in 2020, according to the report. The published average U.S. selling price for the drug declined by 38% in the fourth quarter of 2021 from the same period in 2020.

U.S. sales of Neulasta nevertheless accounted for 5.8% of Amgen’s 2021 revenue, according to data compiled by Bloomberg LP.

Amgen is represented by Richards, Layton & Finger PA; Paul, Weiss, Rifkind, Wharton & Garrison LLP; and in-house counsel. Hospira is represented by Heyman Enerio Gattuso & Hirzel LLP, Winston & Strawn LLP, and White & Case LLP.

The case is Amgen Inc. v. Hospira Inc., D. Del., No. 20-cv-201, stipulation and order of dismissal approved 3/21/22.