Business
Alvotech Reports Financial Results for First Nine Months of 2023 and Provides a Business Update
Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022Marketing authorization was
About this update from Alvotech
[{"type":"text","content":"Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022Marketing authorization was received for AVT04 in Canada and Japan, the first for a biosimilar to Stelara® (ustekinumab)The European Medicines Agency proposed market authorization for AVT04 in the 30 member states of the European Economic Area, pending a final decision by the European Commission Approvability of AVT02 and AVT04 in the U.S. now pending satisfactory US Food and Drug Administration (FDA) inspection of Alvotech’s facility in Iceland, currently expected on January 10 – 19, 2024Management will conduct a business update conference call and live webcast on Wednesday November 29, 2023, at 8:00 am ET (13:00 pm GMT) REYKJAVIK, Iceland, Nov. 28, 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 nine months of 2023 and provided a summary of recent corporate highlights. \"We continue to celebrate global biosimilar first, with approvals of AVT04, our biosimilar to Stelara®, in Japan and Canada and a positive CHMP opinion in Europe, also the first for an ustekinumab biosimilar. We look forward to bringing our second product to global markets. We also continued to strengthen our pipeline with a new development and commercialization partnership for AVT23, a biosimilar candidate to Xolair®, which has already entered into a confirmatory patient study,” said Robert Wessman, Chairman and CEO of Alvotech. “A forthcoming FDA reinspection, scheduled for January 2024, sets the stage for potential approval of AVT02 in the U.S. by the BsUFA date in late February 2024. AVT02 is well positioned to be the first interchangeable high-concentration biosimilar to Humira® in the U.S. market. A satisfactory FDA inspection should also pave the way for approval of AVT04 in the U.S. by the end of April 2024, well in advance of the license entry date in February of 2025.” Recent Highlights Alvotech and Fuji Pharma announced marketing approval in Japan for AVT04, a biosimilar to Stelara® (ustekinumab). This was the first approval of a biosimilar to Stelara in global markets. Alvotech and JAMP Pharma also announced the receipt of a marketi...