Core Insights - Teva Pharmaceuticals has received marketing authorizations from the European Commission for two denosumab biosimilar candidates, PONLIMSI and DEGEVMA, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) earlier this year [1][9]. Group 1: Product Approvals - The approvals of PONLIMSI and DEGEVMA represent a significant milestone in Teva's biosimilars portfolio, enhancing patient access to essential biologic therapies across Europe [2][9]. - Teva plans to launch both products in key European markets in the coming months, aligning with its Pivot to Growth strategy [2][9]. Group 2: Product Details - PONLIMSI is indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, as well as for bone loss associated with hormone ablation in men with prostate cancer [4][6]. - DEGEVMA is indicated for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone [7][10]. Group 3: Mechanism of Action - Both PONLIMSI and DEGEVMA contain denosumab, a human monoclonal IgG2 antibody that targets the protein RANKL, crucial for the formation and survival of osteoclasts, thereby reducing bone resorption [5][8]. - PONLIMSI will be available as a 60mg/1mL solution for injection in a pre-filled syringe, while DEGEVMA will be available as a 120mg/1.7mL solution for injection in a vial [5][8]. Group 4: Company Commitment - Teva's leadership emphasizes the importance of these approvals in increasing patient access to biosimilar therapies for serious bone conditions, reflecting the company's commitment to improving healthcare options in Europe [3][9]. - The company aims to provide additional treatment options for healthcare systems, particularly in regions where access to biosimilars is limited [3].