Slideshow: 2023 Biosimilar Approvals
In addition to the numerous adalimumab (Humira) biosimilars that launched this year, multiple new biosimilar products were approved by the FDA in 2023.
In addition to the numerous adalimumab (Humira) biosimilars that launched this year, multiple new biosimilar products were approved by the FDA in 2023.1 These products included an additional adalimumab biosimilar, an IL-6 receptor antagonist for rheumatoid arthritis and juvenile idiopathic arthritis, and a biosimilar to ustekinumab (Stelara) indicated for multiple inflammatory diseases.
References
1. Biosimilar product information. FDA. Reviewed November 1, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
2. Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar. News release. Celltrion Healthcare. May 24, 2023. Accessed November 28, 2023. https://www.celltrionhealthcare.com/board/en_newslist/102
3. FDA approves first biosimilar to treat multiple sclerosis. News release. FDA. August 24, 2023. Accessed November 28, 2023.https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-multiple-sclerosis
4. Sandoz receives FDA approval for Tyruko (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis. News release. Novartis. August 25, 2023. Accessed November 28, 2023. https://www.novartis.com/news/media-releases/sandoz-receives-fda-approval-tyruko-natalizumab-sztn-first-and-only-fda-approved-biosimilar-relapsing-forms-multiple-sclerosis
5. FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. FDA. September 29, 2023. Accessed November 28, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis
6. FDA approves Biogen’s Tofidence (tocilizumab-bavi), a biosimilar referencing Actemra. News release. Biogen. September 29, 2023. Accessed November 28, 2023. https://investors.biogen.com/news-releases/news-release-details/fda-approves-biogens-tofidencetm-tocilizumab-bavi-biosimilar
7. FDA approves interchangeable biosimilar for multiple inflammatory diseases. News release. FDA. October 31, 2023. Accessed November 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases
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