European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva® [Yahoo! Finance]
Alvotech (ALVO)
Company Research
Source: Yahoo! Finance
“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-exclusive commercial rights in Europe, including Switzerland and the UK. In July 2024, Alvotech announced positive topline results from a confirmatory patient study for AVT03. The AVT03-GL-C01 study, which met its primary endpoints, demonstrated clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in 532 postmenopausal women with osteoporosi
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ALVO
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- Alvotech's Position In The Coming Biosimilar Gold Rush [Seeking Alpha]Seeking Alpha
- 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