Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area
Alvotech - Ordinary Shares (ALVO)
Company Research
Source: GlobeNewswire
REYKJAVIK, Iceland, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia® and Xgeva® (denosumab). The European denosumab market is currently valued at approximately US$1.2 billion across all indications, based on originator sales in the last 12 months including the second quarter of 2025[1]. Denosumab is widely used to manage osteoporosis and to prevent skeletal related events in patients with certain cancers. A biosimilar option can help broaden access to these established treatments in Europe. AVT03 is approved in two presentations: as a biosimilar to Prolia® 60 mg/mL single use pre-filled syringe for the treatment of osteoporosis and bone loss; and as a biosimilar to Xgeva® 70 mg/mL single use vial for the prevention of skeletal related events in adults with a
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ALVO
News
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- Alvotech (NASDAQ:ALVO) was given a new $10.00 price target on by analysts at Morgan Stanley.MarketBeat
- Alvotech (ALVO) Faces Investor Scrutiny Amid Manufacturing Deficiencies Severely Impacting Assurances of 2025 Revenues and Adjusted EBITDA, Stock Tumbles 33% -- Hagens BermanPR Newswire
- Alvotech (ALVO) Q3 2025 Earnings Call Highlights: Strong Revenue Growth Amid Regulatory Challenges [Yahoo! Finance]Yahoo! Finance
ALVO
Earnings
- 11/12/25 - Beat
ALVO
Sec Filings
- 11/24/25 - Form 6-K
- 11/20/25 - Form 6-K
- 11/17/25 - Form 6-K
- ALVO's page on the SEC website