According to an announcement published on the website of the Budapest Stock Exchange, the approval, based on a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, issued on June 19, allows Richter to market the product in Europe under the brand name USYMRO.
Ustekinumab is a monoclonal antibody used to treat autoimmune conditions, including psoriasis, Crohn’s disease, and ulcerative colitis.
The new medicine strengthens Richter’s growing biosimilar portfolio, following recent EC approvals of its denosumab biosimilars.
“We are pleased that Richter will further strengthen patient access to biosimilars in Europe through bringing USYMRO to market,” said Dr. Erik Bogsch, head of the Biotechnology Business Unit at Richter. “As a result of Bio-Ther a’s success in gaining EC approval, Richter is expanding its biosimilar portfolio subsequent to the recent EC approvals of its in-house developed denosumab biosimilars,” he added.
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