Key insights
- Alvotech SA's stock surged after the FDA approved a supplement to its Biologics License Application for AVT02, allowing the company to manufacture the drug substance in a second production suite at its Reykjavik facility. This approval effectively doubles manufacturing capacity for U.S. supply and enhances commercial flexibility. The news follows the resolution of previous inspection-related matters, marking a significant regulatory and operational milestone for Alvotech.
Investing.com -- Alvotech SA (NASDAQ: ALVO) shares jumped 13.5% Monday after the U.S. Food and Drug Administration approved a supplement to the Biologics License Application for AVT02, enabling the company to manufacture the drug substance in a second production suite at its Reykjavik facility.
The approval allows Alvotech to produce AVT02 (adalimumab-ryvk), marketed in the U.S. as SIMLANDI, in either of two drug substance suites at the Reykjavik site. The addition of the second suite, DSM2, effectively doubles the drug substance manufacturing capacity available to support U.S. supply and provides greater flexibility for commercial operations.
The approval follows the FDA's July closure of its most recent inspection of the Reykjavik facility with a Voluntary Action Indicated classification, further confirming resolution of inspection-related matters at the site.
"This approval is important both operationally and as a further regulatory milestone for our Reykjavik facility," said Lisa Graver, Chief Executive Officer of Alvotech. "The addition of DSM2 effectively doubles the drug substance manufacturing capacity available to support U.S. supply and provides greater flexibility for commercial supply of AVT02 to the U.S. market."
DSM2 is already approved for the manufacture of commercial drug substance for European markets, including for AVT02, AVT03, and AVT05. The suite supports the complete drug substance manufacturing process, including cell culture and purification.
Alvotech expects the FDA to be able to take action on other pending applications associated with the facility according to their respective goal dates. These include BLAs for AVT05, a proposed biosimilar to Simponi and Simponi Aria, AVT06, a proposed biosimilar to Eylea, AVT03, a proposed biosimilar to Prolia and Xgeva, and AVT16/AVT80, proposed biosimilars to Entyvio.
AVT02 is approved as a biosimilar to Humira in more than 50 countries globally. Teva Pharmaceuticals is Alvotech's strategic partner for exclusive commercialization of SIMLANDI in the United States.
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