The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Biocon Ltd.'s subsidiary Biocon Biologics Ltd. marketing authorization for its Denosumab biosimilars, Vevzuo and Evfraxy.
According to Biocon, Vevzuo has been licensed to prevent skeletal-related occurrences like pathological fractures, spinal cord compression, and the requirement for radiation therapy or bone surgery in adults with advanced bone-related cancers.
It is also recommended for the treatment of adults and adolescents with skeletal maturity who have giant cell tumors of the bone that cannot be removed or when surgery could result in serious side effects.
Evfraxy has been approved to treat osteoporosis in men and women who are at higher risk of fractures after menopause.
Its use in lowering the risk of hip, non-vertebral, and vertebral fractures in postmenopausal women is also covered by the approval.
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Evfraxy is also recommended for the treatment of bone loss brought on by hormone ablation in males with prostate cancer and by long-term systemic glucocorticoid therapy in adults who are susceptible to fractures.
The company said that clinical studies have shown that both biosimilars are as safe and effective as the reference medicine.
Prior to this, Denosumab biosimilars were given marketing authorization by the European Commission (EC), which permitted their sale in all EU member states as well as the European Economic Area (EEA).
Previously, Biocon Biologics announced that Health Canada had issued a Notice of Compliance (NOC) for Yesafili, the medication used to treat age-related macular degeneration (AMD). The medication is a biosimilar to aflibercept and is sold by US biotech giant Regeneron Pharmaceuticals under the trade name Eylea.
This approval makes Yesafili injection the first biosimilar to Eylea to be licensed by Health Canada, paving the path for its July 4, 2025, Canadian launch.
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In the biologics industry, a biosimilar is the biological equivalent of a generic medication; it is very close to an approved reference product and does not differ clinically in terms of potency, purity, or safety.
Yesafili's approval was predicated on a thorough submission of clinical, nonclinical, and analytical data. Health Canada came to the conclusion that there are no clinically significant differences between the biosimilar and Eylea in terms of efficacy, safety, or quality.
The Phase 3 INSIGHT research compared Yesafili and Eylea in individuals with diabetic macular edema, bolstering the regulatory approval. The experiment revealed no clinically significant variations in the two medications' pharmacokinetics, safety, efficacy, or immunogenicity, the company said.