FDA accepts Sandoz submission for proposed biosimilar

Monday, October 5, 2015

The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.

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Report: Biosimilars could create $44B in healthcare savings

Wednesday, November 5, 2014

Introducing competing biosimilar versions of complex biologic drugs used to treat illnesses such as cancer and rheumatoid arthritis could cut spending on biologics in the U.S. by $44 billion over the next decade, according to a new analysis from RAND, a Boston, Mass.-based nonprofit research organization that develops solutions to public policy challenges.

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