"Celltrion biggest beneficiary of global biosimilar regulatory streamlining"

[Lim Jeong-yeo, Edaily Reporter] Celltrion announced Friday that it will immediately incorporate newly announced global regulatory updates aimed at streamlining biosimilar development into its ongoing pipeline programs, with the goal of significantly reducing development costs and timelines.

The company expects that the latest policy changes, combined with its expanding multi-product portfolio, will serve as a catalyst for achieving unprecedented economies of scale across its biosimilar business.

(Photo=Celltrion)

The U.S. Food and Drug Administration (FDA) recently announced the fourth revision of the "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act," aimed at streamlining the biosimilar development process. The revised draft guidance recommends streamlining clinical pharmacokinetic (PK) testing typically conducted during Phase 1 trials when scientifically justified.

One of the most notable revisions involves the relaxation of comparator product requirements. Previously, biosimilar developers seeking approval in the United States were required to conduct direct PK comparison studies using a U.S.-licensed reference product. Under the updated guidance, however, comparative clinical data generated using a comparator product approved outside the United States may also be accepted to support a demonstration of biosimilarity.

This change is expected to significantly reduce development costs, particularly in the immuno-oncology field where reference biologics are extremely expensive. Celltrion maintains strong competitiveness in this area with multiple products currently under development. The company therefore expects this measure alone could reduce overall clinical development costs by up to 25%. When combined with the FDA's draft guidance issued in October last year aimed at reducing or waiving certain Phase 3 clinical studies, the overall cost-saving effect across the development process is expected to increase further.

Although the revised guidance remains in draft form, Celltrion believes it reflects the FDA's latest perspective, and plans to immediately apply the updated regulatory approach to its ongoing development programs to significantly shorten development timelines and reduce costs.

Even prior to the regulatory changes, Celltrion has maintained industry-leading cost competitiveness through its integrated capabilities spanning development, manufacturing and direct sales. With a direct sales network already established across most key markets and additional savings expected from reduced clinical and comparator product costs, this cost advantage is expected to strengthen further.

Celltrion also views the regulatory streamlining not merely as a cost-reducing measure, but as a strategic lever to achieve larger economies of scale across its entire product portfolio. By reinvesting resources saved through streamlined clinical requirements into additional pipeline development, the company expects to accelerate the expansion of its mid- to long-term product portfolio, including products targeting small and mid-sized markets that were previously difficult to pursue due to high clinical development costs.

Streamlined regulatory requirements for clinical data and approval procedures are elevating the importance of expertise in antibody analytics, comparability assessment and process development, thereby favorably positioning companies like Celltrion who possess robust early-stage development capabilities.

Beyond the 11 biosimilar products currently marketed globally, Celltrion plans to expand its portfolio to 41 products by 2038. Through this expansion, the company expects to target a global market projected to exceed KRW 400 trillion, more than four times larger than the KRW 85 trillion addressable market recorded last year. Celltrion believes that the recent global trend toward regulatory streamlining could support a further expansion of its product development plans.

Key disclosed pipeline programs include CT-P53 (Ocrevus biosimilar), CT-P55 (Cosentyx biosimilar), CT-P52 (Taltz biosimilar) in autoimmune diseases, as well as CT-P51 (Keytruda biosimilar) and CT-P44 (Darzalex biosimilar) in oncology. In addition, more than 20 additional pipeline programs remain undisclosed.

Notably, Celltrion recently reduced Phase 3 clinical trial enrollment for CT-P55 from 375 patients to 153, reflecting the impact of regulatory streamlining and suggesting the potential for faster development timelines.

"The global trend toward regulatory streamlining presents a significant opportunity for Celltrion, which possesses strong early-stage development capabilities, large-scale manufacturing capacity and a global direct sales network," a Celltrion official said. "By reinvesting the cost savings to further expand our pipeline, we aim to achieve greater economies of scale and strengthen our cost competitiveness as we continue advancing toward becoming a leading global biopharmaceutical company."