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Stock impact report

Teva receives FDA approval for Prolia biosimilar [Yahoo! Finance]

Alvotech (ALVO) 
Company Research Source: Yahoo! Finance
a biosimilar to Prolia, alongside the acceptance of its biosimilar candidate applications for Xolair (omalizumab) by both the agency and the European Medicines Agency (EMA). The FDA approval of Ponlimsi is based on a comprehensive evidence package, including analytical and clinical data showing immunogenicity, safety, and similar efficacy to Prolia. Ponlimsi is approved for all indications of the reference product, such as treating postmenopausal women with osteoporosis at high risk of fracture and increasing bone mass in men with osteoporosis. Additional indications include glucocorticoid-induced osteoporosis in men and women at high fracture risk, increasing bone mass in men undergoing androgen deprivation therapy for nonmetastatic prostate cancer, and in women undergoing adjuvant aromatase inhibitor therapy for breast cancer. The EMA granted marketing authorisation for Teva's Ponlimsi in November 2025, following a positive opinion from the Committee for Medicinal Products f Show less Read more
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