Shots:
- The UK’s MHRA has approved Otulfi (SC & IV), biosimilar of J&J’s Stelara (ustekinumab), to treat mod. to sev. active Crohn’s disease, ulcerative colitis, plaque psoriasis as well as active psoriatic arthritis & is set to enter UK market as per a confidential settlement b/w the companies and J&J. It is approved across the US, EU & Canada
- Approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent efficacy, safety & PK to Stelara in mod. to sev. plaque psoriatic patients
- In addition, Formycon & Fresenius Kabi partnered in Feb 2023 under which the latter secured Otulfi’s commercial rights in the international markets, incl. the UK
Ref: Formycon | Image: Formycon & Fresenius Kabi
Related News:- Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel
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