Alvotech Gains on EMA Nod for Key Osteoporosis Biosimilar
Positive opinion for AVT03 paves the way for European approval of a biosimilar to Amgen's blockbuster drugs Prolia and Xgeva.
Icelandic biotech firm Alvotech (ALVO) saw a significant positive development as the for its AVT03 biosimilar candidate. The recommendation from the EMA's Committee for Medicinal Products for Human Use (CHMP) is a crucial step toward full marketing approval in the European Union.
The drug, a proposed biosimilar to Amgen's Prolia and Xgeva (denosumab), is a high-value biologic used for treating osteoporosis and preventing skeletal-related events in cancer patients. Gaining access to the lucrative European market represents a major commercial milestone for Alvotech and its partners.
This positive opinion adds to a series of recent regulatory successes for the company. The CHMP also adopted a , a biosimilar to Simponi (golimumab). Furthermore, this news follows Alvotech's recent announcement that its partner, Fuji Pharma, received marketing approval for AVT03 in Japan, highlighting the company's expanding global reach.
Regulatory milestones like these are critical for biosimilar developers, as they validate the scientific and manufacturing processes while unlocking major revenue opportunities. While the final decision rests with the European Commission, the CHMP's positive opinion is typically a strong indicator of eventual approval. The introduction of biosimilars is expected to increase competition and lower healthcare costs, a key objective for European health systems.
For underscores the strength of its development pipeline. The successful progression of AVT03 and other candidates through stringent regulatory pathways positions the company as a significant player in the global biosimilars market, challenging established blockbuster biologics.