Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)
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
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
