On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”) and related entities, alleging infringement of 28 patents relating to Genentech’s PERJETA and Biocon’s proposed biosimilar, Bmab1500. As we previously…
On June 26, 2026, Viridian Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) approved LUMVOA™ (veligrotug-vvze) for the treatment of thyroid eye disease (“TED”), regardless of disease activity or duration. LUMVOA is Viridian’s first FDA-approved medicine and its first commercial product. TED is a rare autoimmune disease characterized…
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On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued new draft guidance aimed at further streamlining the development of biosimilar and interchangeable biosimilar products by reducing certain clinical pharmacokinetic (PK) study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…