Celltrion has expressed optimism about its enhanced global competitiveness following the recent relaxation of biosimilar development regulations by global regulatory authorities, including the U.S. Food and Drug Administration (FDA). The company anticipates achieving economies of scale through reduced development costs and shorter timelines.
Industry reports from Friday indicate that the FDA recently unveiled the fourth revision of its Biosimilar Development Guidelines Q&A, aimed at streamlining the biosimilar development process. This revision recommends more efficient methods for conducting pharmacokinetic (PK) tests for biosimilars, typically performed in Phase 1 clinical trials, provided that scientific requirements are met.
The most significant change is the relaxation of requirements for the reference drug. Previously, companies had to conduct direct PK comparative clinical trials with a U.S.-approved reference drug to enter the American market. Now, clinical data comparing to a reference drug approved outside the U.S. will be accepted to demonstrate equivalence.
This is particularly beneficial for Celltrion, which is developing multiple products in the competitive field of immuno-oncology, where reference drug costs are exceptionally high. The company expects to reduce overall clinical costs by up to 25% from this measure alone.
Moreover, when combined with the guidelines for simplifying and exempting Phase 3 clinical trials announced last October, the cost savings during product development are expected to increase substantially.
Although the current revision is still in draft form, Celltrion believes it reflects the FDA’s latest stance and plans to apply it immediately to ongoing development projects, significantly reducing both costs and development timelines.
Celltrion already operates a direct sales system in most markets, which significantly lowers its distribution costs compared to competitors. With the additional savings from clinical and reference drug costs due to these regulatory changes, the company expects to further strengthen its cost competitiveness.
Industry analysts predict that the resources saved will be heavily reinvested in developing additional pipelines, accelerating the expansion of Celltrion’s long-term product portfolio.
A Celltrion spokesperson stated that the global trend toward regulatory easing presents a golden opportunity for Celltrion, which possesses early development capabilities, large-scale production, and a direct sales network. It aims to become the biggest beneficiary of these changes. By reinvesting the reduced costs, it will expand our pipeline more comprehensively, achieve economies of scale, and establish themselves as a big pharma player with unmatched cost competitiveness in the global market.
Meanwhile, Celltrion plans to expand its portfolio to 41 products by 2038, building upon the 11 biosimilar products currently available in the market.