Alvotech Wins FDA Nod for 2nd Simlandi Manufacturing Suite

FDA has approved a supplement to the biologics license application (BLA) for adalimumab-ryvk (Simlandi), Alvotech's biosimilar to Humira (adalimumab), the company announced October 5, 2026, enabling AVT02 drug substance for US commercial supply to be manufactured in a 2nd production suite at Alvotech's Reykjavik, Iceland, facility.¹ The approval, which doubles the drug substance manufacturing capacity available for US supply, further confirms resolution of FDA inspection-related matters at the site.¹

What does the new production suite change operationally?

The new suite, DSM2, supports the complete drug substance manufacturing process, including cell culture and purification, and was already approved for commercial drug substance manufacturing for European markets, including for AVT02, AVT03, and AVT05. Following the FDA approval, Alvotech can now manufacture AVT02 drug substance for US commercial supply in either DSM1 or DSM2, adding capacity and flexibility across its operations.¹

"This approval is important both operationally and as a further regulatory milestone for our Reykjavik facility," said Lisa Graver, JD, CEO of Alvotech, in a company press release.¹ "The addition of DSM2 effectively doubles the drug substance manufacturing capacity available to support US supply and provides greater flexibility for commercial supply of AVT02 to the US market. It also reflects the significant progress our teams have made in strengthening quality systems and manufacturing operations at the site."

How does this fit Alvotech's regulatory history at Reykjavik?

The approval extends a multiyear regulatory track record at Alvotech's only manufacturing site. FDA issued a complete response letter for AVT02's BLA in April 2023, citing deficiencies at Alvotech's manufacturing facility that needed to be resolved before approval.² AVT02 ultimately won FDA approval and launched in the United States as Simlandi, and the agency closed its most recent inspection of the Reykjavik facility in July 2026 with a Voluntary Action Indicated classification. The latter outcome still requires a written response but falls short of a warning letter.¹ Alvotech said it now expects the agency to act on other pending applications tied to the facility according to their individual goal dates.¹

What is Alvotech's commercial structure for Simlandi in the US?

Teva Pharmaceuticals has served as Alvotech's exclusive US commercialization partner for Simlandi since the companies expanded their biosimilars partnership in 2023, with Alvotech responsible for development and manufacturing.³ That expanded agreement included a $40 million investment by Teva in Alvotech convertible bonds, milestone and sales-based payments to Alvotech, and on-site manufacturing oversight from Teva at the Reykjavik facility.³ AVT02 is approved as a Humira biosimilar in more than 50 countries, marketed as Simlandi in the US and Canada, Hukyndra in Europe, and Adalacip in Australia.¹

What other Alvotech biosimilars could benefit from the inspection resolution?

Several other Alvotech BLAs tied to the Reykjavik site remain under FDA review, including proposed biosimilars to golimumab (Simponi, Simponi Aria; AVT05), aflibercept (Eylea; AVT06), denosumab (Prolia, Xgeva; AVT03), and vedolizumab (Entyvio; AVT16/AVT80).¹ Simlandi also joins a growing roster of interchangeable Humira biosimilars competing for US market share, including Celltrion's adalimumab-aaty (Yuflyma), which received FDA interchangeable designation in April 2025.⁴

What are the limitations?

Alvotech said each pending application remains subject to the FDA's individual review and regulatory decision, so approval is not guaranteed even with the Reykjavik inspection resolved. The company has not disclosed the specific deficiencies cited in its past FDA actions at the site, and no new inspection or manufacturing performance data accompanied this announcement.

References

1. Alvotech. FDA approves additional US manufacturing capacity for Simlandi, Alvotech's biosimilar to Humira. Press release. Published October 5, 2026. Accessed October 5, 2026. https://www.alvotech.com/newsroom/fda-approves-additional-u-s-manufacturing-capacity-for-simlandi-alvotech-s-biosimilar-to-humira
2. Alvotech. Alvotech provides regulatory update on AVT02 biologics license application. Press release. Published April 13, 2023. Accessed October 5, 2026. https://www.businesswire.com/news/home/20230413005840/en
3. Teva Pharmaceuticals. Teva Pharmaceuticals and Alvotech provide update on strategic biosimilars partnership. Published July 24, 2023. Accessed October 5, 2026. https://www.tevapharm.com/news-and-media/latest-news/teva-pharmaceuticals-and-alvotech-provide-update-on-strategic-biosimilars-partnership/
4. Celltrion. US FDA grants interchangeable designation to YUFLYMA (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab). Published April 15, 2025. Accessed October 5, 2026. https://www.celltrion.com/en-us/company/media-center/press-release/3894