Teva submits first internally developed biosimilar, TVB-009P, for osteoporosis treatment to FDA and EMA.
Teva Pharmaceutical Industries Ltd. announced that the FDA and EMA have accepted applications for its biosimilar candidate, TVB-009P, aimed at treating osteoporosis in postmenopausal women. This marks Teva's first internally developed biosimilar submission to the U.S. FDA. Both agencies are expected to make decisions by the second half of 2025. TVB-009P has not yet received any regulatory approval.
October 08, 2024
5 Articles