Marketing authorization issued in European Economic Area for Uzpruvo®, the first biosimilar to Stelara®, a biologic therapy within gastroenterology, dermatology, and rheumatology
Authorization paves way for biosimilar competition in the approximately €2.5 billion (US$2.7 billion) EU ustekinumab market as soon as possible after expiry of intellectual-property rights in July 2024
Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, including the AVT04-GL-301 confirmatory comparative efficacy and safety clinical trial in patients with moderate to severe chronic plaque-type psoriasis
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.