FDA approves first tocilizumab biosimilar for treatment of rheumatoid arthritis, JIA
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Key takeaways:
- The Actemra biosimilar’s approval was based on data from two studies.
- There is no timeline for when Tofidence will be available in the United States.
The FDA has approved Tofidence as the first tocilizumab biosimilar in the United States for the treatment of rheumatoid arthritis and other conditions, according to a statement from the manufacturer.
In addition to adults with RA, Tofidence (tocilizumab-bavi, Biogen) is approved for patients aged 2 years and older with polyarticular juvenile arthritis or systemic juvenile idiopathic arthritis, the FDA said in a release.
“The approval of Tofidence in the United States marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” Ian Henshaw, global head of biosimilars at Biogen, said in the company statement. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for health care systems and an increase in physician choice and patient access to biologics.”
The FDA based their approval on “a comprehensive, analytical, non-clinical and clinical data package” submitted by Biogen in September 2022, which demonstrated the biosimilarity of Tofidence to tocilizumab (Actemra, Genentech), according to Biogen. In addition, a randomized, double-blind, single-dose, parallel phase 1 study, as well as a randomized, double-blind, multidose three-arm parallel phase 3 study, demonstrated that the drug is acceptable as a biosimilar, the company said.
“Biosimilars, just like all FDA-approved biological products, undergo rigorous evaluation to help ensure their safety, effectiveness, and quality,” the FDA said in its own release.
Tofidence was developed by Bio-Thera. However, according to a 2021 commercialization and licensing agreement, Biogen maintains exclusive regulatory, manufacturing and commercial rights in all territories and countries excluding China, the company said in its release.
Biogen has not announced a potential timeline regarding the availability of Tofidence in the United States.
References:
FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis. Sept. 29, 2023. Accessed Oct. 2, 2023.
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