Alvotech, LOTTE Biologics Forge Strategic Biosimilars Manufacturing Pact

Alvotech, a global biotechnology company, and LOTTE Biologics, a contract development and manufacturing (CDMO) organization, have entered a long-term strategic manufacturing partnership covering biosimilar products.

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.

Strengthening Global Supply Capabilities and Expanding Capacity

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 quality and regulatory capabilities.

The agreement expands Alvotech’s U.S.-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.

Lisa Graver, CEO of Alvotech, said, “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,” added 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.”

Commercial supply will be subject to successful technology transfer, manufacturing qualification and applicable regulatory approvals.