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

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Fresenius Kabi

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

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  • 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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Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com

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