Teva biosimilar candidate is accepted for review by U.S. FDA, E.U. EMA

Teva Pharmaceutical Industries announced that the United States Food and Drug Administration, FDA, has accepted, and the European Medicines Agency, EMA, has validated, applications for TVB-009P, a biosimilar candidate to Prolia. Both applications, a Biologics License Application, BLA, in the U.S., seeking interchangeability, and a Marketing Authorization Application, MAA, in the European Union, EU, include all indications approved for the reference product, Prolia, including conditions with a high risk for fracture, such as osteoporosis in postmenopausal women. The FDA’s anticipated decision and EMA’s expected opinion are anticipated in the second half of 2025.