FDA accepts abbreviated BLA for Biogen’s tocilizumab biosimilar
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The FDA has accepted an abbreviated biologics license application for a tocilizumab biosimilar candidate, according to a press release from Biogen.
“The FDA filing is supported by phase 3 data from a comparative clinical trial demonstrating equivalent efficacy and a comparable safety and immunogenicity profile to the reference product,” Ian Henshaw, the head of global biosimilars at Biogen, said in the release. “We look forward to working with regulators to bring this potential treatment option for people with immune-mediated inflammatory diseases.”
The filing for the candidate, BIIB800, is supported by positive data through 24 weeks of follow-up, the release said. The data comes from a phase 3 multicenter, randomized, double-blind, parallel-group, active-control, global study. The study compared BIIB800 with tocilizumab (Actemra, Genentech) in 621 patients with rheumatoid arthritis who mounted “inadequate” responses to methotrexate alone, according to the release.
“The data from the phase 3 comparative clinical trial demonstrated that the biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product,” the release said.
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