Tofidence, a tocilizumab biosimilar developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
The FDA has granted approval for Tofidence (tocilizumab-bavi), the first biosimilar in the United States to reference Actemra, according to an announcement from Biogen. The product will be used to treat several rheumatic conditions, including rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
“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. “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.”
Tofidence was developed and will be manufacturered by Bio-Thera Solution and will be marketed by Biogen. As part of a commercialization and license agreement, Biogen has exclusive commercialization rights to Tofidence in all countries excluding China, which includes Hong Kong, Macau, and Taiwan. Biogen also is responsible for any regulatory filings in other countries.
The company said that it is still evaluating when to launch Tofidence in the United States. In July, the maker of Actemra, Roche, filed a lawsuit against Biogen, accusing the latter of infringing several of Roche’s patents regarding the development of Tofidence. Roche claimed that Biogen failed to provide detailed information during the biosimilar approval process that was necessary to determine whether the company infringed on Roche’s manufacturing patents. The result of this litigation will likely determine the date when Biogen will be allowed to launch Tofidence.
The approval comes about 10 months after the FDA agreed to review the application in December 2022. The FDA is also reviewing a biologics license application for Fresenius Kabi’s tocilizumab biosimilar candidate.
The biosimilar was approved in China in January 2023. Tocilizumab products are recombinant humanized monoclonal antibodies that target IL-6 receptors, which bind to soluble and membrane-bound IL-6 receptors and inhibit signaling.
In the United States, the reference product is approved for the treatment of RA, giant cell arthritis, systemic sclerosis–associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19.
According to Biogen, the FDA’s decision was based on data from preclinical and clinical trials that demonstrated the biosimilarity of Tofidence compared with its originator.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.