Fresenius Kabi, a subsidiary of Fresenius, and Formycon AG, a leading biosimilars developer, have received FDA approval for Otulfi™ (ustekinumab-aauz). This biosimilar targets Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Otulfi™ was developed through a comprehensive evaluation of data, demonstrating its biosimilarity to Stelara® in efficacy, safety, and pharmacokinetics. It offers a broader treatment solution for healthcare professionals and patients requiring ustekinumab therapy.
Fresenius Kabi’s strong commitment to expanding its biopharma portfolio has led to Otulfi™’s approval, the company’s fourth biosimilar in the U.S. market. The wider biopharma portfolio aligns with their Vision 2026 strategy to establish a significant presence in the biopharma industry and provide crucial treatment options globally.
Formycon AG holds a global commercialization partnership with Fresenius Kabi for Otulfi™. Ustekinumab, the active ingredient in Otulfi™, is a monoclonal antibody that targets interleukin-12 and interleukin-23, key inflammatory cytokines.
Fresenius Kabi’s biosimilar pipeline continues to grow, with autoimmune and oncology biosimilars in various stages of development. This reinforces their dedication to delivering accessible and affordable healthcare solutions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
