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CHMP Updates - September'25
- Oncofocus Team
- Sep 23
- 2 min read
Highlights from the CHMP Sep 2025 Meeting are out!
New Biosimilars
💊 Teva Pharmaceuticals' Degevma (RANKL inhibitor; denosumab biosimilar) is indicated for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone
💊 Reddy Holding GmbH's Xbonzy (RANKL inhibitor; denosumab biosimilar) is indicated for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone
💊 STADA Group Arzneimittel AG's Zvogra (RANKL inhibitor; denosumab biosimilar) is indicated for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone
Indication Expansions
💊 Merck & Co/MSD's Keytruda (anti-PD-1; pembrolizumab) monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1
💊 Keytruda SC: The CHMP adopted a new pharmaceutical form, solution for injection, associated with two new strengths (790 mg and 395 mg), along with a new route of administration, subcutaneous use
👉 Looking for more details on these recommendations, their registrational trial design and outcomes, and impact on the landscape? Reach out to us at support@oncofocus.com, and we will take it from there.
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