FDA approves Biogen’s biosimilar to Roche's arthritis drug Actemra
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Drugmaker Biogen (NASDAQ:BIIB) on Friday said the U.S. Food and Drug Administration (FDA) had approved its biosimilar to Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) arthritis treatment Actemra (tocilizumab).
According to BIIB, its treatment, a monoclonal antibody called Tofidence, becomes the first tocilizumab biosimilar to gain FDA approval in the United States.

The regulator's approval of Tofidence was based on an analytical, non-clinical and clinical data package submitted by BIIB comparing Tofidence to Actemra.
Tofidence will be an intravenous formulation and has been approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
"With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics," Ian Henshaw, global head of biosimilars at Biogen (BIIB), said in a statement.
Actemra was developed by Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) Genentech and has been approved by the FDA for various types of arthritis. The company is also repurposing it as a treatment for COVID-19.
Biogen (BIIB) stock earlier closed -0.3% at $257.01.

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