Biogen's Tofidence Intravenous Formulation Gets FDA Approval

By Denny Jacob

Biogen's tofidence intravenous formulation was approved by the U.S. Food and Drug Administration, the biopharmaceutical company said Friday.

The company said the tofidence intravenous formulation was approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Tofidence intravenous formulation is a biosimilar monoclonal antibody referencing actemra. Biosimilars are products that have been demonstrated to have equivalent efficacy and comparable safety as its approved reference product.

"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," said Ian Henshaw, global head of biosimilars at Biogen.

Biogen and Bio-Thera entered into a commercialziaiton and license agreement for tofidence in April 2021. Developed by Bio-Thera, tofidence will be commercialized by Biogen in the U.S.

Under their agreement, Biogen has exclusive regulatory, manufacturing and commercial rights to tofidence in all countries excluding China. It is currently evaluating the potential launch timeline for tofidence in the U.S.

Write to Denny Jacob at [e-mail]

(END) Dow Jones Newswires

September 29, 2023 16:34 ET (20:34 GMT)

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