On Jan. 29, 2024, Alvotech announced the positive top-line results from a PK study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab. Prolia and Xgeva are registered trademarks of Amgen Inc. (4) There are currently no approved biosimilar products as of today, February 1, 2024. The global denosumab market which was USD 2,892.17 million in 2022, would rocket up to USD 7,109.92 million by 2030, and is expected to undergo a CAGR of 11.9% during the forecast period. (5)
On Jan. 22, 2024, Alvotech provided updates on the status of the BLAs for AVT02 (adalimumab) and AVT04. Alvotech stated that the reinspection of Alvotech’s facility in Iceland by the FDA which started on January 10, 2024, has been concluded. And, Alvotech received a form 483 with one observation. They believe that the observation is readily addressable, and they intend to respond as quickly as possible. Alvotech believes it is in a position to receive approval in the U.S. for AVT02 and AVT04 by February 24, 2024, and April 16, 2024, their respective goal dates. (3)
On Jan. 10, 2024, STADA and Alvotech announced that the European Commission issued a marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab). The centralized marketing authorization for Europe’s first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 EU Member States as well as in Iceland, Liechtenstein, and Norway. This European marketing authorization for Uzpruvo paves the way for market entry in July 2024. (1) Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing therapy within gastroenterology, dermatology, and rheumatology.
On October 12, 2023, FDA issued a complete response letter to Alvotech's application for AVT04, citing issues at the company's Reykjavik facility. Alvotech plans to resubmit the biologics license application. Anyway, AVT04 has been approved in Japan. (2)
Please check with Reference for accuracy and details. Thanks.
Reference
1. STADA and Alvotech secure approval for Uzpruvo, Europe's first ustekinumab biosimilar to Stelara, GlobeNewswire, Source: Alvotech, January 10, 2024.
2. FDA denies Stelara biosimilar application from Alvotech, Healio, October 12, 2023.
3. Yahoo News, January 20, 2024.
4. Yahoo News, January 29, 2024.
5. databridgemarketresearch.com (accessed on Feb. 1, 2024)
