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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Hiltzik: So much for Trump’s ‘manufacturing wins’

Based on the words of President Trump, America is well on the way to becoming a “global superpower in manufacturing” — indeed, as he declared in a Father’s Day social media post, we are already experiencing the “BEST ECONOMY EVER.” (Capitalization’s his.)

Here’s what the government’s own statistics tell us: Manufacturing investment has crashed during his watch, with construction spending in the manufacturing sector down 26.4% from Trump’s inauguration through May, to $174.8 billion. That’s the lowest figure since February 2023, when the economy was in the midst of a post-pandemic recovery.

White House spokesman Kush Desai told me by email that “the last two jobs reports” showed manufacturing job growth. The Bureau of Labor Statistics reported a seasonally-adjusted decline of 2,000 manufacturing workers in May and a gain of 3,000 in June. But the June 2026 figure was 38,000 jobs, or about 0.3% below the level in June 2025, and 75,000 or about 0.6% below the level in January 2025, when Trump took office.

Desai said that “thanks to President Trump’s proven agenda of tariffs, deregulation, and tax cuts, American manufacturing will continue to rebound.”

There’s little mystery about what has come between Trump’s ambition and the real world. To a large extent it’s Trump’s economic program, particularly his tariff policies and, more recently, his war with Iran. Those have injected a level of uncertainty for corporate managements pondering whether to spend money on expansion that they haven’t had to confront in years.

From where we’re standing, we are not seeing signs of a manufacturing renaissance in the U.S.

— Didi Caldwell, Global Location Strategies

The tariffs and the war have driven up manufacturers’ costs for raw materials and overseas shipping. The general economic atmosphere doesn’t help. U.S. gross domestic product growth came in at a 2.1% annualized rate in the first quarter of this year, but the Federal Reserve Bank of Atlanta expects it to have fallen to 1.3% in the second quarter ended June 30.

Meanwhile, the University of Michigan consumer confidence index reached 44.8 in May, its lowest level ever (though it improved to 49.5 in June). Wages have been rising modestly, according to the Bureau of Labor Statistics, but those gains have been eaten up by higher prices, especially for gasoline and food.

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To put things another way, the actual figures show the U.S. economy to be sputtering, and the “vibe economy” as measured by consumer confidence is doing even worse.

Now that Trump’s second term is about to reach its 18-month mark, let’s unpack the factors causing the discrepancy between his ambitions and claims, and the reality.

Trump declared economic victory just as his term was starting. On March 20, 2025, he proclaimed a “manufacturing renaissance” in the U.S. That was based on what he said were “trillions of dollars in new investments” he had “already secured in tech-based manufacturing.”

A White House statement said “the list of manufacturing wins is endless.” The provided list was a roster of announcements, not groundbreakings, much less completed ventures.

Business executives quite properly have taken these pledges with mounds of salt. “Announcements are what people say they’re going to do, but dollars spent is what’s actually happening,” Didi Caldwell, chief executive of a firm that helps companies find factory sites, told the Financial Times. “From where we’re standing, we are not seeing signs of a manufacturing renaissance in the U.S.”

Indeed, at least some of these announcements have had the flavor of performative efforts to satisfy Trump’s amour propre and extract government concessions.

For example, Apple Chief Executive Tim Cook appeared with Trump at the White House in August to announce a $600-billion U.S. spending plan to take place over four years. That was a $100-billion increase over its previously-announced program.

More to the point, however, it incorporated spending with suppliers that Apple had been working with for years. Mentioned in the news announcement was a commitment to buy cover glass for iPhones from Corning. But Corning has been supplying that glass since the first iPhone appeared in 2007. In any case, the announcement appeared to secure a commitment from Trump to exempt Apple from tariffs imposed on imported chips.

Apple’s announcement Wednesday that it will spend $30 billion to buy chips from Broadcom was similarly ambiguous. The announcement didn’t provide details about the terms of the commitment or the timing of its expenditures. I asked Apple for details and whether the deal was related to a desire to remain in Trump’s favor, but didn’t hear back.

A similar phenomenon occurred during Trump’s first term; Trump had built much of his 2016 presidential campaign on a promise to increase manufacturing jobs in the United States. He blamed shrinkage in the manufacturing sector on trade agreements such as NAFTA and the policies of the Chinese, and took credit when an American manufacturer agreed to create or save jobs in the United States.

As I reported in 2019, many of those arrangements turned out to be exaggerated or bogus, or predated Trump’s claim. Some disappeared as soon as public attention turned elsewhere, or were outweighed by job cuts made elsewhere by the same companies.

Trump’s tariffs appear to have had a direct effect on manufacturing employment in the U.S. Since Trump’s inauguration, the manufacturing sector has shed about 75,000 jobs, or 0.6%. After April 2, 2025, when he announced global “liberation day” tariffs supposedly as a response to years of unfair treatment of American exports, the decline picked up pace, with a shrinkage of 68,000 manufacturing jobs.

The Supreme Court invalidated those tariffs in February, but others are still in place, including tariffs on imported steel and aluminum and on goods from China. Nor has he ceased threatening partners with trade wars. As recently as Tuesday, he said he would cut off all trade with Spain because of that country’s disagreement with him over its defense spending and its criticism of his Iran war.

As it happens, Spain is one of the few countries with which the U.S. has a trade surplus. That means that any cutoff, which trade experts think will be unlikely, would come at a cost to the U.S.

One might have hoped that Trump had learned a lesson from his first-term trade war with China. That conflict provoked a sharp contraction in the manufacturing economy, with the Institute for Supply Management’s purchasing managers index falling to 49.1 by mid-2019. (A reading below 50 signifies contraction.)

The ISM index began to recover toward the end of Trump’s term but fell again during the pandemic. Lately it has been falling again, to 53.3 in June from 54 in May.

The Iran war is another deadweight on domestic manufacturing. That’s partially the consequence of blockages of the Strait of Hormuz, the crucial thoroughfare not only for middle eastern oil, but also for such industrial inputs as fertilizer and aluminum. Cement, concrete, olive oil and spices are also among commodities produced in the region that use the strait as an outlet to reach the outside world.

Uncertainties in the region, tensions between the U.S. and China, and heightened concerns over the safety of shipping overall have driven up shipping costs between the far east and the U.S. The price of shipping a benchmark 40-foot container from China to the West Coast has nearly quadrupled to $6,687 now from about $1,700 just before the Iran war began, according to an index maintained by the cargo firm Freightos — even though shipping prices typically decline during this time of year.

There can be little doubt that the U.S. would benefit from an industrial policy — if it’s coherent. China supplanted America as the world’s leading exporter of manufactured goods in 2010, and the gap has only widened since then. China’s dominance may be hard to reverse, as it’s built on lower labor costs and transport infrastructure that enjoys focused government investment.

Tariffs could be a component of a new industrial policy, but Trump’s tariffs aren’t rationally geared to protecting domestic industries that need protection. They’re expressions of his whims, and as such they’re totally ineffective. If there are government investment policies targeting industries that need assistance, they’re not apparent to economists or industrialists.

Trump can talk as much as he likes about a golden age for U.S. manufacturing, but from his first term through this one, it’s nothing but talk. And talk, of course, is cheap.

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