Biocon Biologics, headquartered in India, has announced that two biosimilars it has developed referencing denosumab have been granted marketing authorization in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) (1). The company said that the biosimilars were also recently given marketing authorization by the European Commission (EC), allowing for their commercialization in all European Union member states and the European Economic Area.
The biosimilars, Vevzuo and Evfraxy, were shown in clinical data to have comparable safety and efficacy to denosumab, according to a July 7, 2025 press release from Biocon Biologics (1). Denosumab has previously been available under the brand names Prolia and Xgeva, both Amgen products (2).
Different indications for approved drugs
Key Takeaways
- Biocon Biologics secured MHRA and EC approvals for two denosumab biosimilars—Vevzuo and Evfraxy—each targeting distinct bone-related indications.
- Vevzuo is approved for skeletal-related events in advanced bone malignancies, while Evfraxy addresses multiple osteoporosis and therapy-related bone loss indications.
- The denosumab biosimilars mark Biocon’s third and fourth biologics approved in the UK within 18 months, underscoring the company’s continued expansion in the region’s biosimilars market.
Despite Vevzuo and Exfraxy both being biosimilars of the same drug, they were approved for differing indications by MHRA. Vevzuo has been authorized for prevention of skeletal-related events, such as pathological fracture, spinal cord compression, and surgery or radiation to bone in adult patients with advanced bone malignancies (1). Additionally, it received an indication for adults or “skeletally mature adolescents”—an age range was not given—with unresectable giant cell tumor of the bone, or for whom surgical resection may result in severe morbidity.
Evfraxy was authorized for treatment of osteoporosis in both men and postmenopausal women at increased risk of fractures, with Biocon saying the drug significantly reduced the risk of vertebral, non-vertebral, and hip fractures (1). The MHRA authorization of Evfraxy came on the same day that the Scottish Medicines Consortium announced that it had accepted another treatment for osteoporosis in post-menopausal women, Theramex’s Eladynos (abaloparatide) (3).
Additional indications for Evfraxy that were authorized by MHRA include treatment of bone loss associated with either hormone ablation in men with prostate cancer or long-term systemic glucocorticoid therapy in adult patients, any of whom may be at increased risk of fractures (1).
Biocon’s progress in UK biosimilars market
For Biocon Biologics, the marketing authorizations for Vevzuo and Evfraxy bring the company’s list of regulatory approvals for biologics in the UK to four in the past 18 months (4). One of those was the May 2025 approval of a ustekinumab biosimilar, Yesintek, referencing the originator biologic Stelara that is made by Janssen Biotech, a Johnson & Johnson company (5). Yesintek was the second biosimilar to Stelara approved in the European market, following STADA and Alvotech’s Uzpruvo, which was launched in July 2024 after a January 2024 EC approval (6).
Biocon’s ustekinumab biosimilar is indicated for the treatment of adults and children aged six and older who have moderate to severe plaque psoriasis, as well as adults with active psoriatic arthritis or moderately to severely active Crohn’s disease (5).
References
1. Biocon Biologics. Biocon Biologics Receives MHRA UK Approval for Vevzuo and Evfraxy, Denosumab Biosimilars. Press Release. July 7, 2025.
2. Cancer Research UK. Denosumab Injection (Prolia, Xgeva). CancerResearchUK.org, Dec. 5, 2023 (accessed July 7, 2025).
3. Theramex. SMC Recommends Eladynos (abaloparatide) for Treating Osteoporosis in Postmenopausal Women. Press Release. July 7, 2025.
4. Comment received via email correspondence, July 7, 2025.
5. Biocon Biologics. Biocon Biologics Receives MHRA Approval for Yesintek, Biosimilar Ustekinumab. Press Release. May 25, 2025.
6. Alvotech. STADA and Alvotech Launch Uzpruvo, the First Approved Ustekinumab Biosimilar to Stelara, Across Europe. Press Release. July 22, 2024.
