Celltrion announced on the 13th that it will immediately incorporate recent global regulatory easing policies into its biosimilar pipeline development. The company aims to achieve full-scale growth through reduced development costs and shortened timelines.
The policy changes are expected to serve as a catalyst for realizing economies of scale, aligning with Celltrion's multi-product portfolio strategy. The U.S. Food and Drug Administration recently recommended measures to streamline pharmacokinetic (PK) testing through revised biosimilar development guidelines.
The most notable change is the relaxation of reference drug requirements. Previously, companies seeking U.S. market entry were required to conduct comparative clinical trials using U.S.-approved reference drugs. Going forward, biosimilar equivalence can be established using reference drug data approved in regions outside the United States.
Reference drug costs are particularly high in the immuno-oncology sector. The new measures are expected to reduce overall clinical trial costs by up to 25%. Celltrion plans to immediately apply these changes to ongoing projects, significantly cutting both costs and development timelines.
Celltrion has already secured cost competitiveness through its integrated infrastructure spanning development, manufacturing, and direct sales. Resources saved from regulatory easing will be channeled into additional pipeline development. This will enable the company to expand its product lineup to include small and mid-sized market products that were previously difficult to develop due to cost constraints.
The growing importance of early-stage development and data analysis capabilities also works in Celltrion's favor. The company maintains a competitive edge in early-stage technologies, including antibody analysis and process development.
Celltrion plans to build a portfolio of 41 products by 2038. The global market size is projected to exceed approximately 400 trillion won. The company is currently developing major pipeline candidates including Ocrevus and Keytruda biosimilars, with more than 20 additional undisclosed pipeline projects underway.
"The global trend toward regulatory easing presents an opportunity for Celltrion, with its early-stage development capabilities and direct sales network, to become the biggest beneficiary," a Celltrion official said. "We will leap forward to become a global big pharma with unrivaled cost competitiveness."