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Amgen's biosimilar of J&J's blockbuster Remicade wins US FDA approval


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Amgen's biosimilar of J&J's blockbuster Remicade wins US FDA approval

Amgen Inc. said the U.S. Food and Drug Administration approved its biosimilar of Johnson & Johnson's Remicade for treatment of autoimmune disorders including rheumatoid arthritis and psoriasis.

The Thousand Oaks, Calif.-based biotechnology giant said the U.S. regulator has authorized the use of Avsola, or infliximab-axxq, to treat the same approved indications as Remicade.

Amgen's biologics license application for Avsola was based on a phase 3 study that found no meaningful difference with Remicade in patients with rheumatoid arthritis, according to the company's Dec. 6 press release.

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

New Brunswick, N.J.-based J&J's revenue from Remicade, once its top-selling medicine, is on a decline after losing patent protection first in Europe in 2015 and later in the U.S. in 2018. Biosimilar competition continues to erode the product's market share and drug sales were down almost 17% to $1.14 billion in the third quarter from $1.38 billion in the year-earlier period.

New York-based pharmaceutical giant Pfizer Inc. has two U.S.-approved biosimilar versions of Remicade, while Merck & Co. Inc.'s and Samsungbioepis Co.Ltd.'s biosimilar Renflexis got approval from the FDA in April 2017.

Kenilworth, N.J.-based Merck gave manufacturing rights for Renflexis to South Korean biopharmaceutical company Samsung Bioepis in October 2018 but retained marketing rights for the biosimilar in the U.S.