FDA approves Otulfi as fourth Stelara biosimilar for chronic inflammatory diseases
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Key takeaways:
- Otulfi, an ustekinumab biosimilar, is approved for all indications of the reference product, including Crohn’s and ulcerative colitis.
- The drug is expected to be available in the United States in February.
The FDA has approved subcutaneous and IV formulations of the Stelara biosimilar Otulfi for Crohn’s disease, ulcerative colitis and all other indications approved for the reference product, according to a press release from Fresenius Kabi.
Not only is Otulfi (ustekinumab-aauz; Fresenius Kabi, Formycon AG) Fresenius Kabi’s fourth biosimilar to launch in the U.S. market, but also the fourth FDA-approved biosimilar for Stelara (ustekinumab, Janssen) after the approval of interchangeable biosimilar Pyzchiva (ustekinumab-ttwe; Samsung Bioepis, Sandoz) in July. Following a patent settlement between Fresenius Kabi, their partner Formycon and Johnson & Johnson, this newest biosimilar is set to enter the U.S market by February 2025, according to the release.
“The FDA approval of Otulfi, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. and worldwide,” Sang-Jin Pak, MD, president of biopharma and member of the Fresenius Kabi Management Board, said in the press release. “In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”
According to the company, the FDA based its decision on “thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data.” Indications for Otulfi include moderately-to severely active Crohn’s disease, moderately-to severely active ulcerative colitis, moderate-to severe plaque psoriasis and active psoriatic arthritis in adults. The drug is also approved for pediatric patients with moderate-to-severe plaque psoriasis and active PsA.
“This marks our second FDA approval this year and we are very proud of achieving this milestone in line with our plans,” Stefan Glombitza, PhD, CEO of Formycon AG, said in a company release. “Our ustekinumab biosimilar exemplifies Formycon’s technical expertise and capabilities in developing high-quality, safe and affordable biologics. Particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment. It is important to us to improve access to biosimilars as quickly and broadly as possible.”
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