TEVA News & Events

Teva Pharmaceutical announced that its applications for a proposed biosimilar candidate to Xolair, oromalizumab, have been accepted for review by both the U.S. FDA and the European Medicines Agency. The regulatory submissions consist of a Biologics License Application to the FDA and a Marketing Authorization Application to the EMA. Teva noted both applications include all indications approved for the reference product, including moderate-to-severe persistent allergic asthma.

Teva Pharmaceutical announced the U.S. FDA has approved Ponlimsi as a biosimilar to Prolia. The company stated Ponlimsi is approved for all indications of the reference product, including the treatment of postmenopausal women with osteoporosis at high risk for fracture. The approval was based on evidence demonstrating similar efficacy, safety, and immunogenicity to Prolia.