The European Medicines Agency (EMA) is currently reviewing marketing applications for two notable pharmaceutical products: Sanofi’s rilzabrutinib and Alvotech/Advanz Pharma’s golimumab biosimilar (AVT05). These applications represent significant developments in the treatment of autoimmune conditions and the expanding biosimilar market.
Rilzabrutinib, developed by Sanofi, is an investigational drug under evaluation for the treatment of immune thrombocytopenic purpura (ITP). ITP is an autoimmune disorder characterized by a low platelet count, leading to an increased risk of bleeding and bruising. The drug aims to address the unmet medical need for effective and targeted therapies in ITP patients.
Alvotech and Advanz Pharma have jointly developed AVT05, a biosimilar of golimumab. If approved, AVT05 would be the first biosimilar version of golimumab to reach the European market, offering a potentially more affordable alternative for patients requiring golimumab treatment. Golimumab is a TNF-alpha inhibitor used to treat various inflammatory conditions.
It is important to note that neither rilzabrutinib nor the golimumab biosimilar has been approved in any market worldwide. The EMA's review process will involve a thorough assessment of the drugs' safety, efficacy, and quality to determine whether they meet the stringent regulatory standards for marketing authorization in the European Union.
