STADA and Alvotech launch first approved Stelara biosimilar in Europe

German generics drugmaker STADA Arzneimittel (SAZ: Xetra) and Iceland-based Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara (ustekinumab) in Europe, across a majority of European countries.

As European sales of US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Stelara currently exceed 3 billion euros ($3.27 billion), including the patented ulcerative colitis indication), this is one of the largest biosimilar opportunities over the next few years, STADA noted.

This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry. The pioneering launch comes immediately upon expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology, dermatology and rheumatology.