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Amgen seeks US FDA approval for biosimilar version of J&J's blockbuster Remicade

Amgen Inc. is seeking U.S. approval of a biosimilar competitor to Johnson & Johnson's Remicade treatment for autoimmune disorders including rheumatoid arthritis and psoriasis.

The Thousand Oaks, Calif. biotechnology giant said it submitted a biologics license application to the U.S. Food and Drug Administration for the biosimilar, known as ABP 710. Biosimilars are lower-cost versions of biologic medicines, which are derived from living cells and therefore more challenging to replicate.

A phase 3 study comparing ABP 710 to Remicade, also called infliximab, in patients with rheumatoid arthritis found no meaningful differences between the two therapies, Amgen said.

Amgen has two U.S.-approved biosimilar medicines and three approved for use in the EU.

New Brunswick, N.J.-based Johnson & Johnson has seen revenue from Remicade, one of its best-selling medicines, decline as biosimilars erode the product's market share. Remicade brought in $1.38 billion in the third quarter, down from $1.65 billion in the year-earlier period.

Pfizer Inc. has two U.S.-approved biosimilar versions of Remicade, including Inflectra, which has spurred litigation between the two drugmakers.