Alvotech’s Denosumab Biosimilar Takes Steps Forward With EMA Filing Acceptance

Regulatory Submissions For AVT03 In Other Major Global Markets Are Expected ‘Soon’

15 Oct 2024

Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA.

Figure walking over blocks representing goals towards a flag finish — (Shutterstock)

First one in the bag. The European Medicines Agency has accepted Alvotech’s marketing authorization application for its AVT03, a denosumab rival to Amgen’s Prolia/Xgeva brands, for review.

“EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe,” said Alvotech’s chief scientific...