FDA Approves 1st Biosim for Actemra – Tofidence

Continuing our focus on Biosimilars

The FDA recently approved a new infused biosimilar, Tofidence (tocilizumab-bavi) from Biogen, for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Tofidence is a biosim to reference product Actemra, a first competitor for that brand (although at least there is one additional biosim candidate inching its way towards approval).

The approval of this biosimilar is noteworthy if only for the fact that yet another unchallenged brand has fallen to a biosimilar competitor. As more are approved, biosimilars will be challenging a much larger group of brand name products….. further eroding their near monopoly in many disease categories.

Tofidence was approved without an ‘interchangeable’ designation….. which many still feel is the jewel of biosimdom (yes, new word). It was also approved with a Black Box Warning.

CLICK HERE to view prescribing information

Biogen did not release pricing for Tofidence at time of approval. 

Now, weeks later, pricing info is still not to be found.

Biogen did not release details on distribution.


FDA Approves Biogen’s Tofidence, a Biosimilar Referencing ACTEMRA

Tofidence becomes the first tocilizumab biosimilar to gain FDA approval in the United States

CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The Tofidence intravenous formulation is approved for the treatment of ………………………….. press release continues

CLICK HERE to read the full press release


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