The U.S. Meals and Drug Administration has authorized the biosimilar tocilizumab-bavi (Tofidence), Biogen, the drug’s producer, introduced as we speak.
It’s the first tocilizumab biosimilar authorized by the FDA. The reference product, Actemra (Genentech), was first authorized by the company in 2010.
“The approval of Tofidence within the U.S. marks one other optimistic step towards serving to extra individuals with continual autoimmune situations achieve entry to main therapies,” stated Ian Henshaw, the worldwide head of biosimilars at Biogen, in a press release. “With the rising numbers of authorized biosimilars, we count on elevated financial savings and sustainability for healthcare methods and a rise in doctor selection and affected person entry to biologics.”
Tocilizumab-bavi is an intravenous formulation indicated for remedy of reasonably to severely lively rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
The European Fee authorized its first tocilizumab biosimilar, Tyenne (Fresenius Kabi), earlier this yr in each subcutaneous and intravenous formulations.