European Biologic and Biosimilar Updates

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On January 12, 2026, Sanofi announced that the European Commission approved its Teizeild (teplizumab) for delaying progression to stage 3 type 1 diabetes (“T1D”) in adults and children eight years and older who have stage 2 T1D. Teizeild marks the first disease-modifying treatment for T1D available in the EU. Sanofi also received good news this month about its teplizumab product for the US market, called Tzield, which was accepted for priority review by the FDA for an expanded age indication to young children with stage 2 type 1 diabetes.

In more European biosimilar news, on December 22, 2025, Alvotech announced that its European commercial partner Advanz Pharma has begun launching Gobivaz® (golimumab), the world’s first biosimilar to Johnson & Johnson’s Simponi®, across Europe. Gobivaz, also known as AVT05, is offered in both prefilled syringe and autoinjector presentations. In the United Kingdom, rollout is backed by an NHS England tender award, which establishes a structured pathway for integration within NHS healthcare services.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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