Update on U.S. Regulatory Status of AVT02, Alvotech’s Proposed High-Concentration, Interchangeable Biosimilar to Humira®
Alvotech (NASDAQ: ALVO) announced today that the FDA has granted a new Biosimilar User Fee Amendment (BsUFA) goal date of April 13, 2023, for Alvotech’s original Biologics License Application (BLA) for AVT02 as biosimilar to Humira®.
- U.S. Food and Drug Administration (FDA) has confirmed that the goal date for an approval decision on Alvotech’s license application for AVT02 is April 13, 2023
- FDA has completed review of Alvotech’s application of AVT02 as an interchangeable to high-concentration of Humira® and confirmed that the data provided are sufficient to support a determination of interchangeability; approval requires satisfactory outcome of upcoming facility reinspection
- Alvotech is anticipating a facility reinspection by the FDA in the first quarter of 2023
Approval of the application requires satisfactory outcome of a reinspection of Alvotech’s facility in Reykjavik, Iceland. Alvotech is working with the FDA to schedule a reinspection in the first quarter of 2023.
Communications from the FDA regarding Alvotech’s application supporting interchangeability of AVT02, including a Complete Response Letter received on December 20, 2022, confirmed that the application review is complete. The key requirement for approval is the same as for the original BLA, which is a satisfactory outcome of the facility reinspection.
Róbert Wessman, Founder and Executive Chairman of Alvotech
I’m very pleased to receive confirmation from the FDA that it has completed its review of the interchangeability application for AVT02 and that approval can be granted after Alvotech has fulfilled the agency’s inspection requirements. We remain excited about the anticipated launch of AVT02 in the U.S. on July 1, 2023 and strongly believe that Alvotech’s interchangeable biosimilar will increase patient access in the U.S. to this important therapy.
AVT02 has been launched in 17 markets around the world, including Canada, Germany, and France and has received marketing approval in 35 countries. In March of 2022, Alvotech reached a settlement agreement that grants Alvotech a license entry date in the United States of July 1, 2023. Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), is Alvotech’s exclusive strategic partner for the commercialization of AVT02 in the United States.
Further info can be found on Alvotech website.