Alvotech Wins FDA Approval to Expand U.S. Manufacturing Capacity for SIMLANDI at Reykjavik Facility

Approval enables AVT02 drug substance for U.S. commercial supply to be manufactured in either of Alvotech’s two Reykjavik drug substance suites

Further confirms resolution of FDA inspection-related matters at the Reykjavik site

REYKJAVIK, Iceland (October 5, 2026)

– 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 supplement to the Biologics License Application (BLA) for AVT02 (adalimumab-ryvk), marketed in the U.S. as SIMLANDI®, enabling drug substance for the product to be manufactured in a second production suite at the company’s Reykjavik facility. This approval further confirms resolution of inspection-related matters at the Reykjavik 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. It also reflects the significant progress our teams have made in strengthening quality systems and manufacturing operations at the site.”

The second suite, DSM2, supports the complete drug substance manufacturing process, including cell culture and purification, and doubles Alvotech’s manufacturing capacity available to support U.S. supply. DSM2 is already approved for the manufacture of commercial drug substance for European markets, including for AVT02, AVT03, and AVT05. Following the FDA approval, Alvotech can now manufacture AVT02 drug substance for U.S. commercial supply in either DSM1 or DSM2, providing additional capacity and greater flexibility across its manufacturing operations.

The approval follows the FDA’s July 2026 closure of its most recent inspection of the Reykjavik facility with a Voluntary Action Indicated (VAI) classification. Alvotech therefore 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, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), AVT03, Alvotech’s proposed biosimilar to Prolia® and Xgeva® (denosumab) and AVT16/AVT80, Alvotech’s proposed biosimilars to Entyvio® (vedolizumab). Each application remains subject to the FDA’s individual review and regulatory decision.

About AVT02 / SIMLANDI® (adalimumab-ryvk)

AVT02 is a monoclonal antibody approved as a biosimilar to Humira® (adalimumab) in more than 50 countries globally, including the United States, Europe, Canada and Australia. It is currently marketed in the U.S. as SIMLANDI® and under private label, in Europe as HUKYNDRA®, in Canada as SIMLANDI® and in Australia as ADALACIP®. Teva Pharmaceuticals is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI® in the United States, while Alvotech is responsible for development and manufacturing.

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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.

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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.

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FDA proposals to speed up trials, generics for U.S. pharma firms

WASHINGTON — The Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs.  

FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers.

STAT Plus: White House proposes 12% cut to federal health agencies in 2027 budget request

The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. For example, many of the brand drugmakers that struck deals to lower U.S. prices also promised to increase domestic manufacturing, under the threat of tariffs.

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FDA Announces New Domestic-Manufacturing-Focused Pilot Program

The current administration continues efforts to boost domestic manufacturing.

One of President Trump’s stated goals across all industry has been a desire to reduce the United State’s dependence on imported goods. While he has targeted a wide swath of industries, he has specifically targeted the pharmaceutical industry.

This is most likely due to this particular issue playing a key role in another of the President’s initiatives, reducing the cost of pharmaceuticals in the United States.

On February 1, FDA announced a new pilot program designed to promote the construction of domestic manufacturing sites, along with increasing regulatory predictability and and streamlining manufacturing facility assessments.1

FDA PreCheck will begin in 2026 and include a group of domestic facilities that the agency says are aligned with national priorities. The criteria used to decide this will be:

• Products to be manufactured
• Phase of facility development
• Timeline to producing products to US market
• Innovation in facility development

Also, any facility developing critical medications for the US market will be considered for the initial group.

In a statement FDA Commissioner Marty Makary, MD, MPH, said, “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back. The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”

This is just the latest effort by FDA to promote domestic manufacturing and reduce dependence on imports.

In late January, the agency announced the results of the ImportShield Program, which aims to bring consistent oversight to the import review process across the entire country.2 In order to achieve this, the existing five regional teams were restructured into just one centralized team.

According to FDA, this resulted in:

• An increase to processing speed by 66%
• An increase to monthly volume capacity by 33%
• A reduction in staff hours by 20%

In a press release, Makary said, “Whether it’s detecting counterfeit medications or identifying contaminated food products, the FDA ImportShield Program and other modernization efforts add a powerful new layer of protection for American families.”

Meanwhile, major pharmaceutical companies have been announcing major manufacturing projects within the United States.

The latest example of this is Eli Lilly, who just announced plans to invest $3.5 billion in a manufacturing facility in Lehigh Valley, Pennsylvania.3 The site will focus on injectal medicine and device manufacturing. The site should be operational by 2031.

In a press release, Lilly chair and CEO David A. Ricks said, “”Our mission starts with patients and delivering the medicines they need. To meet increasing demand, we’re expanding our U.S. manufacturing network, with Lehigh Valley adding capacity for next‑generation weight-loss medicines. We’re creating high‑quality jobs and collaborating across the region—with suppliers, educators, and workforce‑development partners—to make critical medicines in the U.S. That’s our commitment—to patients, to our new Pennsylvania home and to our country.”

In the same press release, Pennsylvania Governor Josh Shapiro said, “”When we announced our Economic Development Strategy here in the Lehigh Valley two years ago, we set out to win historic, life-changing deals like the one we’re announcing with Lilly today. Before I took office, Pennsylvania wasn’t even in the conversation for major investments like this, but thanks to our work to cut red tape, invest in site development, and expand our workforce, our Commonwealth is now competing—and winning—on a national scale. Lilly’s commitment to the Lehigh Valley and to Pennsylvania will bring billions of dollars of investment and hundreds of good-paying jobs, solidifying our position as a leader in the growing life sciences industry.”

Sources

1. FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing. FDA. February 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing
2. FDA ImportShield Program Delivers Impressive Results in Strengthening FDA Oversight at U.S. Ports of Entry. FDA. January 21, 2026. https://www.fda.gov/news-events/press-announcements/fda-importshield-program-delivers-impressive-results-strengthening-fda-oversight-us-ports-entry
3. Lilly selects Pennsylvania as home for its newest injectable medicine and device manufacturing facility. Eli Lilly. January 30, 2026. https://investor.lilly.com/news-releases/news-release-details/lilly-selects-pennsylvania-home-its-newest-injectable-medicine

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US FDA launches program to boost domestic drug manufacturing

By Ahmed Aboulenein

WASHINGTON, Feb 1 (Reuters) – The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to ​boost domestic drug supply by speeding up construction and review of drug manufacturing ‌plants in the country.

The FDA said it would select an initial group of new pharmaceutical manufacturing facilities this year ‌based on “alignment with national priorities” in several areas including the product itself, how quickly it can be developed for the U.S. market, and innovations in facility development.

“Additional priority considerations will be given to facilities producing critical medications for the U.S. market,” the agency said in a statement.

The ⁠FDA PreCheck program, first announced ‌in August, aims to streamline review of domestic pharmaceutical plants and eliminate unnecessary regulatory requirements, in line with President Donald Trump’s executive order in ‍May to shift manufacturing of drugs to the United States.

The program introduces a two-phase approach to facilitate new U.S. drug manufacturing facilities.

The initial phase would provide for more frequent communication with the FDA, including ​for facility design, construction and pre-production.

The second phase would facilitate pre-application meetings and early ‌feedback to help streamline the development of manufacturing and quality control processes, the agency said.

The FDA had separately announced another program in June to incentivize drug developers that align with national priorities, including increased domestic manufacturing, with shortened times for reviewing marketing applications.

The FDA Commissioner’s National Priority Voucher Program promised decisions in one or two months on a limited number of ⁠drugs deemed critical to public health or national security, ​cutting four to six months off the fastest priority ​approval process.

Reuters, citing internal documents, reported exclusively last month that the agency had delayed reviews of two drugs chosen for the new fast-track program after ‍agency scientists flagged safety ⁠and efficacy concerns, including the death of a patient while taking one of the medicines.

Two other drugs tapped for the speedy review program have also been pushed by ⁠weeks or longer beyond the original target date. The four drugs are among at least seven in the ‌program that have started their approval process, according to documents.

(Reporting by Ahmed ‌Aboulenein; Editing by Sergio Non and Chizu Nomiyama )

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