Lotte Biologics fires opening shot for Songdo era with major long-term CMO deal [Bio Japan 2026]

Lotte Biologics has fired the opening shot of its "Songdo era," ahead of the November completion of its first plant in Incheon's Songdo district.

The company secured a large-scale drug substance CMO contract with global biosimilar powerhouse Alvotech, and pulled forward the GMP readiness schedule for the Songdo facility by more than six months, setting the stage for full commercial operations.

Jang Jun-young, senior vice president and PMO at Lotte Biologics, said at Bio Japan 2026 at the Pacifico Yokohama Convention Center on Thursday that the 10-year contract with Alvotech follows a linked model — beginning at the company's Syracuse, New York factory before transferring to Songdo Plant 1. "We will verify initial production at the 5,000-liter Syracuse facility, and once volumes grow, we will scale up to the 15,000-liter large commercial plant in Songdo," he said.

The deal marks the first tangible result of Lotte Biologics' "dual-site" strategy. The approach uses the credibility of the Syracuse plant — which holds multiple FDA approvals — to offset concerns about the track record of the newly built Songdo site, then channels that trust into Songdo's large-scale production capacity. A key factor in clinching the contract was the Syracuse plant's flawless performance in an unannounced FDA inspection conducted just before the deal was signed.

"Three weeks ago, the FDA visited the Syracuse site without notice and conducted a five-day unannounced inspection — we received a zero-observation result with no findings whatsoever," Jang said. "Alvotech, having gained complete confidence in our quality, signed the final contract immediately."

The Songdo Plant 1 timeline is also moving faster than expected. Lotte Biologics plans to hold a completion ceremony for the plant in November — nearly six months ahead of the April 2027 GMP-ready date originally targeted.

The company said it obtained building-use approval just two years after breaking ground, and that repeated requests from global customers for an earlier launch prompted it to deploy a large number of veteran personnel from Syracuse to Songdo to accelerate the validation schedule. "The Plant 1 completion will be more than just a building handover — it will be the moment Lotte proves its execution capability on the global stage," the company said.

That quality track record and execution speed are translating directly into business meetings with leading pharmaceutical companies at Bio Japan. "We are holding a series of meetings with top-tier Japanese pharmaceutical companies," Jang said. "Among conservative local customers who place enormous weight on quality track records and Pharmaceuticals and Medical Devices Agency approval history, the proven quality of Syracuse combined with the scale-up option at Songdo is proving to be a powerful competitive advantage."

Jang also expressed confidence in the company's differentiated manufacturing capabilities in antibody-drug conjugates. "There are very few contract development and manufacturing organizations globally that can handle both antibody production and conjugation at a single US site on a one-stop basis," he said. "Because we can eliminate temperature-variation risks during transport and customs clearance issues at the source, inquiries from overseas pharmaceutical companies continue to come in."

"Last year we focused on raising awareness of Lotte's biotech business, but this year — through actual contract wins and verified metrics — we have risen to a position where global pharmaceutical companies seek us out first," Jang said. He added that the company would use the Alvotech deal as a springboard to make additional global partnerships visible around the time of the Songdo completion in November.