Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd., has received marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its Denosumab biosimilars—Vevzuo® and Evfraxy®. This marks another important step in the company’s global biosimilars push.
Vevzuo® has been approved for use in adults suffering from advanced cancers involving the bone. It will help prevent serious skeletal complications like fractures, spinal cord compression, or the need for bone surgery. The drug is also cleared for treating giant cell tumors of the bone in adults and adolescents where surgery isn’t an option or would cause major health issues.
Evfraxy®, on the other hand, is aimed at managing osteoporosis in both postmenopausal women and men who are at higher risk of fractures. It’s been proven to significantly reduce the chances of vertebral, non-vertebral, and hip fractures. The MHRA has also approved it for treating bone loss in prostate cancer patients undergoing hormone therapy and in patients on long-term glucocorticoids—both of whom face an increased risk of fractures.
Both biosimilars have demonstrated safety and efficacy on par with the original reference product in clinical trials.
This UK approval comes on the heels of a recent green light from the European Commission (EC), which cleared the same biosimilars for marketing across the European Union and European Economic Area. With these regulatory wins, Biocon Biologics is solidifying its position as a key global player in the biosimilars space.
