Biocon Biologics secures market entry date for Denosumab biosimilars in Europe & rest of the world

New Delhi: Biocon Biologics has announced a settlement agreement with Amgen Inc. that clears the path for the commercialization of its Denosumab biosimilars in Europe and the rest of the world.

The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo® and Evfraxy®) in Europe starting December 2, 2025. The other terms of the settlement remain confidential.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “This settlement sets the stage for Biocon Biologics to bring our Denosumab biosimilars, Vevzuo® and Evfraxy®, to patients across Europe and key international markets. This follows our settlement in the U.S. in October and further broadens our reach across the world in the oncology and bone health therapeutic areas, as we work with healthcare systems to expand access to affordable biologics globally.” 

The European Commission (EC) had approved Vevzuo and Evfraxy in July 2025. 

Biocon Biologics had secured a market entry date for its Denosumab biosimilars Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) for the United States previously. 

Denosumab is a human monoclonal antibody that targets and binds a protein known as RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand). RANKL plays a crucial role in the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By blocking RANKL, denosumab effectively inhibits the breakdown of bone, leading to increased bone mass and strength.