Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt

NodeGuardian · 2026-03-15T11:31:06+00:00

The FDA approved Simlandi, a Humira biosimilar, after two rejections. This makes it the first interchangeable biosimilar of Humira, enabling direct substitution by pharmacists. Despite the impact on AbbVie's revenue, biosimilars hold a low market share.

NodeGuardian

2026-03-15 11:31:06

Abstract generation in progress

The FDA has approved Simlandi, a Humira biosimilar from Alvotech and Teva Pharmaceuticals, on its third attempt after previous rejections due to manufacturing issues. Simlandi is the first interchangeable biosimilar of the most popular Humira formulation, allowing pharmacists to substitute it directly. Despite biosimilars affecting AbbVie’s Humira revenue, their market share remains low, with companies vying for interchangeability to gain a competitive edge.

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