Alvotech wins U.S. approval to more than double Simlandi output per batch
Key Facts
Alvotech said it secured U.S. Food and Drug Administration approval for a new manufacturing process for Simlandi that more than doubles drug substance output per batch. The company said in a statement that the increase requires no change to the upstream manufacturing scale, allowing higher batch productivity within the existing scale. The approval allows the process to be implemented in the drug substance manufacturing suite at its facility in Reykjavik, Iceland. It added that process development, transfer and validation work demonstrated comparability with the previously approved process while maintaining product quality, safety and efficacy. Chief Operating Officer Joseph McClellan said producing the same volume using "fewer batches" frees up capacity to support other products and increases flexibility in responding to demand.
The move follows an earlier U.S. approval allowing drug substance for the U.S. market to be produced in an additional suite, according to Alvotech's capacity expansion statement. Management said the additional suite "effectively doubles drug substance manufacturing capacity" available to support U.S. supplies. That increase concerns capacity available through the additional suite, while the new process raises the amount of drug substance produced per batch without changing the upstream manufacturing scale. The company had announced that the FDA closed its latest inspection of the Reykjavik facility in July 2026 with a "Voluntary Action Indicated" classification. In response to the earlier approval of the additional suite, Investing reported that Alvotech shares rose 8.1% in premarket trading on 5 October 2026.
On the financial front, Alvotech reported adjusted product and service revenue of $105.9 million in the first half of 2026, compared with $204.7 million in the corresponding period of 2025, a decline of 48.3%. Total adjusted revenue was $211.9 million, compared with $306.1 million, down 30.8%, according to its first-half results statement. Adjusted earnings before interest, taxes, depreciation and amortization also fell to $46.9 million from $53.7 million in the corresponding period. The year-on-year decline in this profitability measure was 12.7%, according to the comparison provided in the company's financial statement. Alvotech ended the first half with a cash balance of $142.8 million, compared with $172.4 million at the end of 2025.
Simlandi received its original U.S. approval on 23 February 2024, and the FDA's Purple Book lists it as an interchangeable biosimilar to Humira. The agency explains that this designation allows pharmacists to substitute the biosimilar for the reference product without consulting the prescriber, subject to each state's pharmacy laws. Alvotech develops and manufactures Simlandi, while Teva holds exclusive U.S. marketing rights, according to the companies' statement on U.S. supplies. Marketing channels for Alvotech-manufactured adalimumab include distribution under Qualent's private label, under an agreement consistent with the marketing partnership with Teva. Alvotech said adalimumab in its Humira biosimilar program is approved in more than 50 countries worldwide.
Alongside its manufacturing operations in Iceland, Alvotech entered into an agreement with Lotte Biologics to produce drug substances for several biosimilars in the United States. The agreement covers the Syracuse facility in New York state, according to the companies' announcement on increasing global supplies. The facility has 40,000 liters of bioreactor capacity, with on-site process development and quality control capabilities. Commercial supplies under the agreement are subject to successful technology transfer and manufacturing qualification, under the terms announced by the companies. The start of those supplies also requires the necessary regulatory approvals, according to the agreement announcement.
Alvotech management had forecast annual revenue of between $650 million and $700 million for 2026 in its first-quarter results statement. The same guidance included adjusted earnings before interest, taxes, depreciation and amortization of between $180 million and $220 million for the year. The company scheduled the release of its third-quarter 2026 results for after the U.S. market close on 11 November 2026, according to its financial calendar. The results release will be followed by a company conference call to discuss quarterly performance on 12 November 2026. The call is scheduled to begin at 08:00 a.m. U.S. Eastern Standard Time, according to the time announced in its earnings calendar.