Alvotech is a biotechnology company focused on the development and commercialization of high-quality biosimilar medicines. The company aims to provide affordable alternatives to branded biologic drugs, addressing the growing demand for cost-effective therapeutic options in various therapeutic areas. Alvotech leverages its proprietary technology platform to produce biosimilars that can offer similar safety and efficacy profiles to their reference products. Through strategic partnerships and a commitment to innovation, Alvotech strives to enhance patient access to vital medications on a global scale. Read More
Alvotech shares decline after the FDA issues a complete response letter for its Simponi biosimilar, leading to a lower 2025 revenue and EBITDA outlook.
Stay up-to-date with the latest market trends in the middle of the day on Monday. Explore the top gainers and losers during today's session in our detailed report.
As we await the opening of the US market on Monday, let's delve into the pre-market session and discover the top gainers and losers shaping the early market sentiment.
REYKJAVIK, Iceland, Nov. 02, 2025 (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 U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab).
REYKJAVIK, Iceland, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced changes to its global business development and commercial operations team. Anil Okay, Chief Commercial Officer, is stepping down to serve as Chief Executive Officer of Adalvo. Trisha Durant has joined Alvotech as Senior Vice President, Global Business Development and Commercial Operation, ex-North America. Harshika Sarbajna is Senior Vice President Commercial, North America. Agne Pasko is Vice President Head of Business Development.
Kashiv BioSciences, LLC, a fully-integrated biopharmaceutical company, announced that they have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA), for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab).
LONDON and REYKJAVIK, Iceland, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair® (omalizumab).
REYKJAVIK, Iceland, Sept. 22, 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 Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03, Alvotech’s proposed biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial). Pending approval, the biosimilar will be marketed by Alvotech’s commercial partners, STADA Arzneimittel AG (“STADA”) and Dr. Reddy’s Laboratories SA (“Dr. Reddy’s”), each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK.
REYKJAVIK, ICELAND and LONDON, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“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’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases.
REYKJAVIK, Iceland, Sept. 19, 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 its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji Pharma”), has received marketing approval for three new biosimilars from the Japanese Ministry of Health, Labor and Welfare. The biosimilars approved for the Japanese market are AVT03, a biosimilar to Ranmark® (denosumab), AVT05, a biosimilar to Simponi® (golimumab) and AVT06, a biosimilar to Eylea® (aflibercept). Based on publicly available information, AVT05 is the first golimumab biosimilar to be approved for sale in major markets globally.
REYKJAVIK, Iceland, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Morgan Stanley 23rd Annual Global Healthcare Conference, which will be held in New York, NY, September 8-10, 2025. Alvotech will be meeting with investors on Tuesday, September 9, 2025, and Dr. Balaji Prasad, Chief Strategy Officer, will participate in a fireside chat on Wednesday September 10, 2025, at 10:45 am EDT (14:45 GMT / 16:45 CET).
REYKJAVIK, Iceland and LONDON, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“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 Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept), in a pre-filled syringe and vial.
REYKJAVIK, Iceland, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for the first six months of 2025 and provided a summary of recent pipeline and corporate highlights. Management will conduct a business update conference call and live webcast on August 14, 2025, at 8:00 am ET (12:00 pm GMT).
