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Alvotech's Denosumab Biosimilar Just Got EU Green Light—Here's Why It Matters
Alvotech (ALVO) landed European Commission approval for AVT03, a biosimilar knockoff of Amgen’s Prolia and Xgeva. Both originals contain denosumab, a widely-used drug for osteoporosis and bone-related cancer complications.
The play? Europe’s denosumab market is worth roughly $1.2 billion annually. A cheaper biosimilar could grab serious market share.
What got approved:
Distribution handled by STADA and Dr. Reddy’s across Europe.
The bigger picture: AVT03 already has Japan approval (September 2025) and FDA accepted the US filing in March 2025. The combo—EU + Japan + pending US—positions Alvotech as a serious player in biosimilar manufacturing.
Alvotech’s CEO pitched it as proof of their “end-to-end biosimilar platform.” They’ve already got approved biosimilars to Humira and Stelara in the pipeline.
Stock moves: ALVO closed Friday at $5.14 (up 1.58%), trading in a $4.70-$13.70 range over the past year. Approval catalysts like this typically move biotech stocks, though execution on commercialization is the real test.