SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. SIMLANDI is the first biosimilar approval under the strategic partnership between Alvotech and Teva in the U.S. market SIMLANDI will qualify for interchangeable exclusivity in the U.S. for some concentration strengths REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industrie ...

REYKJAVIK, Iceland, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara® (ustekinumab). Regulatory approval for AVT04 in these markets has already been granted. Market applications for AVT04 are currently pending ...

The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease REYKJAVIK, Iceland, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for ...

Key PointsCrescent Point Energy's shareholder-friendly nature and potential to benefit from an oil price rebound have Wall Street unanimously bullish.All seven analysts that actively follow biotech company Ardelyx have a buy rating, and the $12.25 consensus target points to about 50% upside over the next 12 months.EV manufacturer VinFast faces an uphill battle against competitors, but its positioning in every SUV segment could make it a viable option for consumers — and a comeback stock worth watching.5 sto ...

Alvotech (ALVO) announced that the FDA has completed the reinspection of the company’s Iceland facility that started earlier this month. Alvotech received a form 483 with one observation after the regulatory body’s reinspection.Previously, certain deficiencies were found at the Iceland facility.Based on this, Alvotech remains confident about receiving approval for its two biosimilar candidates, AVT02 and AVT04, in the United States by Feb 24, 2024 and Apr 16, 2024, respectively.Shares of the company were up ...

REYKJAVIK, Iceland, Jan. 19, 2024 (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 reinspection of Alvotech's facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the ...

Marketing authorization issued in European Economic Area for Uzpruvo®, the first biosimilar to Stelara®, a biologic therapy within gastroenterology, dermatology, and rheumatologyAuthorization paves way for biosimilar competition in the approximately €2.5 billion (US$2.7 billion) EU ustekinumab market as soon as possible after expiry of intellectual-property rights in July 2024Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity dat ...

Alvotech (NASDAQ:ALVO) Q3 2023 Earnings Conference Call November 29, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director of IR and Global Communications Robert Wessman - Chairman and CEO Anil Okay - Chief Commercial Officer Joel Morales - CFO Conference Call Participants Mikaela Franceschina - Barclays Niall Alexander - Deutsche Bank Thibault Boutherin - Morgan Stanley Operator Welcome to Alvotech's Earnings Call for the First Nine Months of 2023. At this time, all participants are in ...

First Six Months of 2023 Results and Business Update August 31, 2023 © ©AL AVLOVTOETCEHC. HA.L ALL RLI GRHIGTHST RSE RSEESREVREVDED Disclaimer ...

Alvotech (NASDAQ:ALVO) Q2 2023 Earnings Conference Call August 31, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Director of IR & Global Communications Robert Wessman - Chairman & CEO Anil Okay - Chief Commercial Officer Joel Morales - CFO Conference Call Participants Carl Byrnes - Northland Capital Markets Thibault Boutherin - Morgan Stanley Niall Alexander - Deutsche Bank Andrew Baum - Citi Operator Welcome to the Second Quarter 2023 Earnings Call for Alvotech. At this time, all participants ...