Stada and Alvotech Receives CHMP’s Positive Opinion for Uzpruvo (Biosimilar, Stelara)
Shots:
- Stada and Alvotech have received positive CHMP opinion for Uzpruvo (AVT04), a biosimilar to Stelara (ustekinumab), for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis, the MAA of which will be valid in the EU states as well as in Iceland, Liechtenstein and Norway
- The MAA was based on analytical and clinical data from the AVT04-GL-301 study in which Uzpruvo depicted therapeutic equivalence to Stelara for moderate to severe chronic plaque-type psoriasis
- Ustekinumab, human IgG1κ mAb, will be developed and manufactured by Alvotech while STADA will be responsible for the commercialization within the EU under their agreement signed in 2019
Ref: STADA | Image: STADA
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
