Alvotech获FDA批准SIMLANDI新工艺Process 2.0，单批原料药产出翻倍以上

REYKJAVIK, Iceland and LONDON, Oct. 20, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has approved a new manufacturing process for SIMLANDI
®
(adalimumab-ryvk), Alvotech’s biosimilar to Humira
®
(adalimumab).
The FDA approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale.
The improvement was achieved through targeted process development, effective process transfer and successful process validation, with demonstrated comparability to the previously approved process, maintaining product quality, safety and efficacy.
“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,” said Joseph McClellan, Chief Operating Officer of Alvotech. “The new process allows us to manufacture the same quantity of drug substance in fewer batches, freeing up capacity to support other products in our portfolio, making better use of our existing infrastructure and giving us greater flexibility to respond to growing demand. Together with the recent FDA approval of additional manufacturing capacity, this demonstrates the strength of our operations in Reykjavik and reinforces our ability to deliver reliable supply to our commercial partners as demand for our biosimilars continues to grow.”
For further information, contact:
Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com
Investors
Dr. Balaji V Prasad
Benedikt Stefansson
Mikaela Vilchez
alvotech.ir@alvotech.com
About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira
®
(adalimumab), Stelara
®
(ustekinumab), Simponi
®
(golimumab), Eylea
®
(aflibercept) and Prolia
®
/Xgeva
®
(denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our
website
or follow us on social media on
LinkedIn
,
Facebook
,
Instagram
, and
YouTube
.
Forward-Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.