European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
Alvotech (ALVO)
Company Research
Source: GlobeNewswire
REYKJAVIK, Iceland and LONDON, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to Simponi. The approvals process is anticipated to be completed in the fourth quarter of 2025. "This is a welcome milestone for us, our partners, patients and caregivers, as we take one step closer to being able to offer access to biosimilar Simponi®," said Joseph M
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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