Biocon Biologics Ltd. (BBL) has announced a settlement with Amgen, clearing the path for commercialization of its Denosumab biosimilars (Vevzuo® and Evfraxy®) in Europe starting December 2, 2025. This agreement broadens Biocon’s reach in oncology and bone health, aiming to improve access to affordable biologics globally. The European Commission approved Vevzuo and Evfraxy in July 2025.
European Market Entry Secured
Biocon Biologics Ltd. (BBL) has finalized an agreement that allows the commercialization of its Denosumab biosimilars, Vevzuo® and Evfraxy®, in Europe starting December 2, 2025. Specific terms of the settlement remain confidential, but the agreement is expected to provide substantial benefits to the company’s revenue stream in the coming years.
Denosumab Biosimilars Overview
The settlement allows Biocon Biologics to proceed with its plans for Vevzuo® and Evfraxy®, biosimilars for Denosumab. This agreement broadens the company’s reach in the oncology and bone health therapeutic areas.
Vevzuo® Indications
Vevzuo® (denosumab biosimilar) is indicated for the prevention of skeletal-related events, specifically pathological fracture and radiation to bone, spinal cord compression, or the necessity of surgery related to the bone in adults affected by advanced malignancies involving bone. It is also indicated for treatment of adults and skeletally mature adolescents facing giant cell tumors of the bone where surgical options are limited or will cause severe morbidity.
Evfraxy® Indications
Evfraxy® (denosumab biosimilar) is indicated for the treatment of osteoporosis in postmenopausal women and in men at an increased risk of fractures. Denosumab significantly reduces the risk of vertebral, non-vertebral, and hip fractures in postmenopausal women.
Associated Bone Conditions
Osteoporosis is a health condition that weakens bones, making them fragile and more likely to break. It is often diagnosed when a fall or sudden impact causes a bone to fracture. Across Europe, an estimated 32 million individuals aged 50+ had osteoporosis in 2019, with 25.5 million being women. Nearly all types of cancer can metastasize to the bone, leading to pain and fractures. In 2022, the number of new cancer cases in the EU reached 2.74 million. Giant cell tumor (GCT) affects young adults, potentially growing aggressively and destroying surrounding bone and soft tissue; GCTs represent 3–5% of primary bone tumors in the United States and Europe.
Source: BSE