Alvotech 与 LOTTE Biologics 达成长期协议，由 Syracuse 工厂生产抗体生物类似药原料药

News|Events|October 7, 2026

Alvotech turns to a CDMO's 40,000-liter Syracuse facility for biosimilar drug substance as it expands its manufacturing network.

Alvotech has agreed to a long-term manufacturing partnership with LOTTE Biologics, under which the contract development and manufacturing organization (CDMO) will produce drug substance for multiple antibody biosimilars at its Syracuse, New York, facility.¹ The companies announced the arrangement October 6, 2026, saying it adds US-based capacity for global supply.¹

“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.”¹

Key Facts

Partners: Alvotech and LOTTE Biologics

Products: Multiple antibody biosimilars (unnamed)

Indications: Not disclosed

Action: Long-term manufacturing agreement

Scope: Drug substance for global supply

Site: Syracuse, New York; 40,000 L bioreactors

Inspection: Unannounced FDA, zero observations

Efficacy and safety data: None reported

Status: Supply needs tech transfer, approvals

What Does the Alvotech–LOTTE Biologics Manufacturing Agreement Cover?

Under the agreement, LOTTE Biologics will manufacture drug substance for multiple antibody biosimilar products for global supply, with potential for the collaboration to expand over time.¹ The release did not name the products or indications, or state the contract value or duration.

The Syracuse facility has 40,000 liters of bioreactor capacity, supported by on-site process development and quality control, and the companies said it recently completed an unannounced FDA inspection with zero observations.¹ Alvotech said the added capacity complements its existing manufacturing partnerships and in-house capabilities, giving it more flexibility to meet demand across international markets.¹

Who Operates the Syracuse Biologics Manufacturing Site?

LOTTE entered biologics contract manufacturing by completing a $160 million acquisition of the Syracuse plant from Bristol Myers Squibb in January 2023, and it then listed the site's capacity at 35,000 liters of antibody drug substance.² The facility is now described as having 40,000 liters of bioreactor capacity, a difference the release does not explain.

The release also says LOTTE Biologics has completed its Songdo Bio Campus in South Korea, giving the CDMO a dual-site network.¹

“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.”¹

How Does the Deal Fit Alvotech's US Regulatory History?

Alvotech develops and manufactures biosimilars and says five are approved and marketed in multiple global markets, including biosimilars to adalimumab, ustekinumab, golimumab, aflibercept, and denosumab. Its pipeline includes candidates for autoimmune disorders, eye disorders, and cancer.¹

In the US, however, FDA review of some applications has turned on findings at the company's Reykjavik, Iceland, facility. In November 2025, the agency issued a complete response letter for golimumab biosimilar candidate AVT05 after a pre-license inspection that concluded in July 2025.

Alvotech said the FDA identified no other deficiencies and that the facility remained approved to supply marketed products.³ An April 2023 complete response letter for adalimumab candidate AVT02 likewise cited deficiencies conveyed after a reinspection of the same site.⁴

The release does not connect the Syracuse agreement to those events and instead frames it as capacity for a growing portfolio.

What Remains Unclear About the Biosimilar Manufacturing Partnership?

Commercial supply remains subject to successful technology transfer, manufacturing qualification, and applicable regulatory approvals, according to the release.¹ The companies gave no timeline for those steps.

The inspection result is the companies' own characterization, and the announcement offers no detail on which products will be made at the site or in what volumes. For biosimilar developers, additional qualified capacity can support supply planning, but the release does not show how much of Alvotech's US supply the arrangement will carry.

Future regulatory filings that list the Syracuse site would clarify its role.

Sources

1. Alvotech and LOTTE Biologics announce US-based manufacturing agreement to increase global supply. News release. Alvotech; LOTTE Biologics. October 6, 2026. Accessed October 7, 2026. https://www.globenewswire.com/news-release/2026/10/06/3376052/0/en/alvotech-and-lotte-biologics-announce-us-based-manufacturing-agreement-to-increase-global-supply.html

2. LOTTE BIOLOGICS completes acquisition of biologics manufacturing plant in Syracuse, NY. News release. LOTTE Biologics. January 3, 2023. Accessed October 7, 2026. https://lottebiologics.com/en/public/newsroom/40

3. Alvotech provides update on the status of U.S. biologics license application for AVT05. News release. Alvotech. November 2, 2025. Accessed October 7, 2026. https://investors.alvotech.com/news-releases/news-release-details/alvotech-provides-update-status-us-biologics-license-0

4. Alvotech provides regulatory update. News release. Alvotech. April 13, 2023. Accessed October 7, 2026. https://investors.alvotech.com/node/8431/html