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 2023.¹ 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