Teva announces FDA, EMA acceptance of proposed Xolair biosimilar applications

Teva (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.