On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS™ (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) as an interchangeable biosimilar to SIMPONI ARIA® (golimumab). IMMGOLIS and IMMGOLIS INTRI are the first biosimilars approved for SIMPONI and SIMPONI ARIA….
On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued new draft guidance aimed at further streamlining the development of biosimilar and interchangeable biosimilar products by reducing certain clinical pharmacokinetic (PK) study requirements when scientifically justified. The announcement builds on an earlier FDA initiative announced in October that…
On November 24, 2025, Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s PROLIA® and XGEVA® (denosumab) in the European Economic Area. AVT03 is approved in two presentations: as a biosimilar to PROLIA® 60 mg/1 mL in a single-use pre-filled syringe for the treatment…