Alvotech and LOTTE Biologics announce US-based manufacturing agreement to increase global supply. October 06, 2026 16:37 ET | Source: Alvotech Collaboration covers multiple biosimilar products to be manufactured at LOTTE Biologics' Syracuse facility in New York Strategic long-term partnership to increase Alvotech's global manufacturing capacity and support growth in demand REYKJAVIK, Iceland, and SEOUL, South Korea, Oct. 06, 2026 (GLOBE NEWSWIRE) - Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and LOTTE Biologics, a contract development and manufacturing (CDMO) organization, today announced a long-term strategic manufacturing partnership. Under the agreement, LOTTE Biologics will manufacture drug substance for multiple antibody biosimilar products at its Syracuse facility in New York for global supply, with the potential to further expand the collaboration over time. The Syracuse facility has 40,000 liters of bioreactor capacity for biologics manufacturing, supported by on-site process development and quality control capabilities. The site has an established track record in commercial biologics manufacturing and recently completed an unannounced FDA inspection with zero observations, further demonstrating its strong quality and regulatory capabilities. The agreement expands Alvotech's US-based manufacturing footprint while strengthening its global supply network. The additional capacity complements Alvotech's existing manufacturing partnerships and its in-house development and manufacturing capabilities, supporting its expanding portfolio and providing greater flexibility to meet demand across international markets. "Alvotech has one of the most comprehensive, internally developed product portfolios in the industry," said Lisa Graver, CEO of Alvotech. "With the expansion of our global manufacturing network, we will have sufficient capacity to meet demand for our pipeline for the next ten years. Our collaboration with LOTTE Biologics will bring additional manufacturing capacity in New York to support patients worldwide, complementing our existing capabilities as we scale our portfolio and prepare for future launches." "Alvotech's expertise in biosimilar development, combined with LOTTE Biologics' manufacturing capabilities, creates a strong foundation for this collaboration," said James Park, CEO of LOTTE Biologics. "We look forward to strategically supporting Alvotech's growing portfolio and the reliable supply of high-quality, more affordable biologic medicines to patients worldwide. With our Syracuse operations and the completion of our Songdo Bio Campus, we are committed to providing flexible, dual-site manufacturing support as the partnership grows." Commercial supply will be subject to successful technology transfer, manufacturing qualification and applicable regulatory approvals. For further information, contact: Investors Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez [email protected] 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(R)(adalimumab), Stelara(R)(ustekinumab), Simponi(R)(golimumab), Eylea(R)(aflibercept) and Prolia(R)/Xgeva(R)(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. About LOTTE Biologics LOTTE Biologics is a global contract development and manufacturing organization (CDMO) providing an integrated biologics solutions to pharmaceutical and biotechnology companies worldwide. With its established commercial manufacturing operations in Syracuse, New York, and the newly completed Songdo Bio Campus in South Korea, LOTTE Biologics is building a flexible, dual-site manufacturing network to support customers from development through commercial supply. 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.

CDMO capacity: stainless by volume, single-use by number. Large stainless-steel projects are rising, but pipeline demand is increasingly moving toward smaller, more flexible manufacturing models. September 15, 2026 Contributing Writer At Sartorius' Process Intensification Forum in Hyderabad, India in June, Miriam Monge, the bioprocess firm's head of Customer and Industry Advocacy, questioned the billions being spent on large stainless-steel capacity across the industry. She highlighted North Carolina, where contract development and manufacturing organization (CDMO) Fujifilm Biotechnologies has opened the first phase of a $3.2 billion site with eight 20,000-liter bioreactors, and Amgen and Genentech have committed a further $1 billion and $2 billion respectively nearby. As such, Monge asked delegates whether capacity on that scale could ever be filled, and whether the local grid and water supply could feed several plants of that capacity in one region. And North Carolina is not alone. A run of large stainless-steel projects has been announced by - specifically - CDMOs elsewhere. Among them Lonza, which is adding six 20,000-liter bioreactors at its headquarters and manufacturing center in Visp, Switzerland; Samsung Biologics, which has built a fifth plant at its Songdo site in South Korea for around $1.5 billion, adding 180,000 liters across twelve 15,000-liter bioreactors; and Lotte Biologics, whose $3.3 billion Songdo Bio Campus will run three plants of eight 15,000-liter stainless-steel bioreactors each, the first due in 2027. Beyond the headlines, it is important to put these news stories in context, according to Dawn Ecker, Managing Director of bioTRAK Database Services at the BioProcess Technology Group, a division of BDO USA. The industry holds about 8.6 million liters of installed bioreactor capacity, with roughly 35% of it run by CDMOs, she told us. By 2030, the total is expected to grow to 10.6 million liters, with nearly half the new capacity - around 915,000 liters - installed by CDMOs. Of that new CDMO capacity, 71% by volume is large-scale stainless steel, she said, but this is being installed by just a handful of companies. When looking at the number of systems, single-use leads, making up 61% of the roughly 120 bioreactors CDMOs are projected to install. The quiet rise of single-use capacity. The single-use build-out is less headline-happy than that of a billion-dollar stainless campus, so it often runs under the radar. Some of the larger examples include WuXi Biologics, which has built up a large single-use based network (including running twelve 4,000-liter single-use bioreactors at its Dundalk site in Ireland); AGC Biologics doubling its single-use capacity in Copenhagen; and Fujifilm, stainless in North Carolina, going single-use in the UK at Teesside. The quieter single-use investments reflect demand moving toward smaller volumes, said Ecker. The share of pipeline products that could be made in a single 2,000-liter bioreactor has risen from 42% in 2021 to 55% today, and among those products the proportion outsourced has risen from 38% to 43% over the same period. "Demand fragmenting is present in the CDMO data," and the trend is expected to continue, she said. Despite this, the large steel plants are not necessarily under-utilized. Ecker was wary of giving utilization specifics but said the market is mostly full. CDMOs do not announce capacity they cannot fill, she noted, because utilization is their main revenue. "Over a quarter of all CDMOs are expanding," she said, "so I would say overall we are mostly full rather than mostly underused." In her experience, expansion talk starts once a site has been booked above 80% for several years running. Scale, of course, is driven by product volume demand. Products above roughly 350,000 liters a year still favor a 20,000-liter stainless line, and those below 20,000 liters suit single-use. The middle, 20,000 to 350,000 liters a year, is harder to define now that single-use runs beyond the one-time ceiling of 2,000 liter bags, and up to 6,000 liters. "As an example, if we estimate that a product has an annual volumetric demand of 180,000 liters per year, we know we could run nine batches in a 20,000 liter reactor and meet demand. But we also know that we could manufacture 180,000 liters per year in single use," she said, either from a bank of 2,000-liter single-use reactors or a smaller number of 5,000 or 6,000-liter ones, depending on the product's cost of goods and whether the capacity is free. Furthermore, intensified processes could reach the same output from smaller equipment again. "As an industry, we keep improving our manufacturing processes for new products - whether that be increasing our titers and process yields or employing N-1 strategies," said Ecker. "The whole idea is to make more in (and with) less - less space, less media, smaller or fewer batches." Based on bioTRAK's numbers, Monge's question goes from rhetorical to measurable. The big stainless plants are largely justified for the high-volume products and the handful of firms building them, while most of the market, and most of the pipeline it now serves, is heading toward smaller, single-use, and more flexible capacity. Dan Stanton is a journalist with 15 years' experience covering bioprocessing and biomanufacturing. He currently works as an editorial specialist at Sartorius. Topics.