Alvotech wins FDA approval to more than double SIMLANDI batch output

More than twice as much SIMLANDI drug substance can be produced per batch after Alvotech STOALVO-SDB NASDAQALVO reported FDA approval for its upgraded manufacturing process on Tuesday. Process 2.0 increases output without increasing upstream manufacturing scale.

The Oct. 20 announcement permits the process in the DSM2 manufacturing suite in Reykjavik, Iceland. The Oct. 20 announcement gives neither an implementation date for Process 2.0 nor an estimate of savings per unit from the increased batch output.

Alvotech is an Iceland-based biotechnology company that develops and manufactures biosimilar medicines for a global network of commercial partners.

Its Swedish depositary receipts STOALVO-SDB rose 7.19 per cent to 53.70 Swedish kronor at 1:12 p.m. CEST in Stockholm on Tuesday. Its Nasdaq shares NASDAQALVO had closed at US$5.03 at 4 p.m. EDT on Monday, before the announcement.

The company said process development, transfer and validation demonstrated comparability with the previously approved process while maintaining product quality, safety and efficacy. The approval concerns manufacturing drug substance for the existing adalimumab biosimilar, rather than a new treatment indication.

"More than doubling drug substance output per batch while maintaining product quality is a significant achievement that reflects the expertise of our process development and manufacturing teams," Alvotech chief operating officer Joseph McClellan said in the release.

Higher Yield Follows A Second Suite Approval

The new process follows a separate FDA approval announced Oct. 5 allowing SIMLANDI drug substance for United States supply to be manufactured in either of the plant's two production suites. Alvotech said that earlier clearance effectively doubled the drug substance capacity available for the American market.

The second suite supports both cell culture and purification and was already approved for European commercial production. Tuesday's announcement adds a yield improvement within DSM2; Alvotech provided no combined annual capacity figure or timetable for additional commercial shipments.

Read more: Alvotech gains FDA approval for second SIMLANDI production suite

The operational changes follow a period when supply constrained sales. In its Aug. 19 financial update, Alvotech said manufacturing improvements affected first-half output and product availability, with operations returning to planned levels at the end of the second quarter.

First-half gross margin was 54 per cent, broadly level with the prior year. Alvotech reported US$142.8 million in cash at June 30. The Oct. 20 release gives no estimate of how Process 2.0 could change that margin, although McClellan said fewer batches would release capacity for other products.

Commercial Supply Enters A Growing Biosimilars Market

Teva Pharmaceutical Industries Ltd. TLVTEVA NYSETEVA is responsible for exclusive United States commercialization, while Alvotech handles development and manufacturing, according to their May 20, 2024 launch announcement. That announcement established SIMLANDI's American availability and listed adult rheumatoid arthritis and adult ulcerative colitis among its approved uses.

Read more: Eli Lilly and Company's Omvoh meets pediatric ulcerative colitis remission endpoint

The sector's expansion is visible in Sandoz Group AG SWXSDZ OTCMKTSSDZNY, which reported first-half biosimilar sales of US$1.875 billion on Aug. 5. Sales grew 20 per cent at constant currencies from the same period in 2025, and biosimilars accounted for a record third of group sales.

Alvotech's financial calendar schedules third-quarter results for Nov. 11, with an earnings call on Nov. 12. The report will show whether the recovery in manufacturing supply described in August translated into stronger sales; Tuesday's release provides no date for the first Process 2.0 commercial batches.