Biocon Biologics Gains Market Entry for Denosumab in Europe
Filing Summary
Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has finalized a settlement with Amgen Inc., enabling the commercialization of its Denosumab biosimilars, Vevzuo® and Evfraxy®, in Europe starting December 2, 2025. The European Commission approved these biosimilars in July 2025. The agreement follows a similar settlement in the U.S. for Denosumab biosimilars Bosaya™ and Aukelso™. The settlement terms remain confidential. Biocon Biologics aims to expand its reach in oncology and bone health markets. The company has commercialized 10 biosimilars and has a pipeline of 20 biosimilar assets.
Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has announced a settlement agreement with Amgen Inc. This agreement allows Biocon Biologics to commercialize its Denosumab biosimilars, Vevzuo® and Evfraxy®, in Europe starting December 2, 2025. The settlement terms remain confidential. This development follows a previous settlement in the U.S. regarding Denosumab biosimilars Bosaya™ and Aukelso™.
The financial terms of the agreement with Amgen Inc. have not been disclosed. The settlement facilitates the entry of Biocon Biologics’ Denosumab biosimilars into the European market, expanding the company’s commercial footprint. The biosimilars Vevzuo® and Evfraxy® have been approved by the European Commission as of July 2025, allowing for their market introduction.
Biocon Biologics’ Denosumab biosimilars target the oncology and bone health therapeutic areas. Vevzuo® is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone and for treating giant cell tumors of bone. Evfraxy® is indicated for treating osteoporosis in postmenopausal women and men at increased risk of fractures, as well as bone loss associated with hormone ablation in men with prostate cancer and long-term glucocorticoid therapy in adults.
The timeline for the commercialization of Vevzuo® and Evfraxy® in Europe begins on December 2, 2025. The European Commission’s approval in July 2025 was a critical milestone, enabling Biocon Biologics to proceed with market entry. The company had previously secured a market entry date for its Denosumab biosimilars in the United States.
The agreement involves Biocon Biologics and Amgen Inc. Biocon Biologics is responsible for the commercialization of the biosimilars in Europe. Amgen Inc. is the original developer of Denosumab, and the settlement clears the path for Biocon Biologics to enter the market with its biosimilars.
Denosumab is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption. By inhibiting RANKL, Denosumab increases bone mass and strength. The European market for osteoporosis and related conditions is significant, with 32 million individuals aged 50 and above estimated to have osteoporosis in 2019. The introduction of Denosumab biosimilars by Biocon Biologics aims to address this market need.
Biocon Biologics is a global biosimilars company focused on transforming healthcare by providing affordable access to high-quality biosimilars. The company has commercialized 10 biosimilars and has a pipeline of 20 biosimilar assets across various therapeutic areas. It leverages cutting-edge science and global manufacturing capabilities to lower the costs of biological therapeutics.
Biocon Ltd. is an innovation-led global biopharmaceutical company committed to enhancing affordable access to complex therapies for chronic conditions. It develops and commercializes novel biologics, biosimilars, and complex small molecule APIs in key global markets. The company is focused on expanding its portfolio and addressing unmet patient needs worldwide.