STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases
Shots:
- Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway
- The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara for treating chronic plaque-type psoriasis demonstrating its similarity as well as results from the (AVT04-GL-101) study showing similar PK characteristics
- Additionally, Alvotech holds rights to develop and manufacture Uzpruvo while STADA is responsible for the commercialization in the EU as per the agreement signed in 2019
Ref: Alvotech | Image: STADA
Related News:- Alvotech and Teva Reports the US FDA’s Acceptance of BLA for Review of AVT04, a Proposed Biosimilar to Stelara (ustekinumab)
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
