European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
Alvotech (ALVO)
Company Research
Source: GlobeNewswire
REYKJAVIK, Iceland, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab). “EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “Successful progression in the development of multiple biosimilar candidates demonstrates how Alvotech is able to leverage its end-to-end biosimilars platform in support of broader access to affordable biologic medicines.” Alvotech develops and manufactures AVT03. STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA, have entered into agreements with Alvotech for the commercialization of AVT03, each partner with semi-exclusiv
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- Alvotech (ALVO) Q3 2024 Earnings Call Highlights: Record Revenue Growth and Strategic Advancements [Yahoo! Finance]Yahoo! Finance
- Alvotech (ALVO) Q3 Earnings and Revenues Beat Estimates [Yahoo! Finance]Yahoo! Finance
- Alvotech Reports Financial Results for the First Nine Months of 2024 [Yahoo! Finance]Yahoo! Finance
- Alvotech Reports Financial Results for the First Nine Months of 2024GlobeNewswire
ALVO
Earnings
- 5/21/24 - Miss
ALVO
Sec Filings
- 11/13/24 - Form 6-K
- 11/6/24 - Form SC
- 11/4/24 - Form 6-K
- ALVO's page on the SEC website