Business
Alvotech Reports Financial Results for First three Months of 2023 and Provides Business Update
Revenue for the first three months of 2023 increased to $15.9 million, compared to $0.8 million for the same period in 2022Confirmatory patient study for
About this update from Alvotech
[{"type":"text","content":"Revenue for the first three months of 2023 increased to $15.9 million, compared to $0.8 million for the same period in 2022Confirmatory patient study for AVT05, a proposed biosimilar for Simponi® and Simponi Aria® (golimumab) initiated, marking the fifth internally developed portfolio candidate to be dosed in a patient studySatisfactory outcome of facility reinspection remains the key requirement for U.S. approval of Biologics License Applications (BLAs) for AVT02, a proposed high-concentration, interchangeable biosimilar to Humira® (adalimumab)Management will conduct a business update conference call and live webcast on Friday, May 19, 2023, at 8:00 am ET (12:00 pm GMT) REYKJAVIK, Iceland, May 19, 2023 (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 unaudited financial results for the first three months of 2023 and provided a summary of recent corporate highlights. \"It is with great pride that we have built a biosimilar-focused platform that now includes five biosimilar candidates that have reached in-patient studies, including AVT02 which is already marketed. I believe that we are well positioned to participate in the promise of global biosimilars for the long-term. And while we are a global company that has launched our first product in 17 markets around the world, we remain committed and focused to bringing AVT02, a proposed high-concentration, interchangeable biosimilar to Humira®, to patients in the United States, after regulatory approval,” said Robert Wessman, Chairman and CEO of Alvotech. “We continue to work collaboratively with the FDA regarding both Biologic License Applications for AVT02 and are preparing for all possible scenarios, including resubmission of the first AVT02 BLA and hosting a possible reinspection of our manufacturing facility, which we would anticipate in 2023, if needed.” Recent Highlights In April 2023, Alvotech received from the US Food and Drug Administration (FDA) a complete response letter (CRL) for the Company’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies conveyed following the FDA’s recent reinspection of the company’s Reykjavik faci...