FDA Approves Otulfi™, a Biosimilar to Stelara®
Fresenius Kabi, and Formycon AG, announced the U.S. Food and Drug Administration (FDA) approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®. Otulfi™ is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
- Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses.
- Otulfi™ demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
- Otulfi™ was approved for both subcutaneous and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.
Source: Fresenius Kabi
