Teva (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.
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