Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)

Shots:

• Following the NOC approval of Tyenne (tocilizumab) & Idacio (adalimumab), Fresenius Kabi Canada has received Health Canada NOC for Otulfi (ustekinumab), a biosimilar to Stelara for Crohn’s disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis
• NOC approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent efficacy, safety, PK & immunogenicity to Stelara in mod. to sev. plaque psoriatic pts
• In February 2023, Fresenius Kabi and Formycon formed a global partnership to commercialize ustekinumab biosimilar in key global markets

Ref: Newswire | Image: Fresenius Kabi

Related News:- Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

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