FDA Approves First Tocilizumab Biosimilar

Lucy Hicks

September 29, 2023

The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-bavi (Tofidence), Biogen, the drug's manufacturer, announced today.

It is the first tocilizumab biosimilar approved by the FDA. The reference product, Actemra (Genentech), was first approved by the agency in 2010.

"The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies," said Ian Henshaw, global head of biosimilars at Biogen, in a statement. "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."

Biogen’s pricing for tocilizumab-bavi will be available closer to the product's launch date, which has yet to be determined, a company spokesman told Medscape. The US average monthly cost of Actemra for rheumatoid arthritis, administered intravenously, is $2,134 - $4,268 depending on dosage, according to a Genentech spokesperson.

Tocilizumab-bavi is an intravenous formulation (20 mg/mL) indicated for treatment of moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). The medication is administered every 4 weeks in RA and PJIA and every 8 weeks in SJIA as a single intravenous drip infusion over 1 hour.

The European Commission approved its first tocilizumab biosimilar, Tyenne (Fresenius Kabi), earlier this year in both subcutaneous and intravenous formulations. Biogen did not comment on whether the company is working on a subcutaneous formulation for tocilizumab-bavi.

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