Celltrion announced on the 13th that it plans to apply the U.S. Food and Drug Administration's regulatory easing policy for biosimilar development to its biosimilar pipeline, aiming to reduce development costs and shorten timelines.
The FDA recently released the "fourth revision of the FDA Biosimilar Development Guidelines Q&A" to streamline the biosimilar development process. Previously, companies seeking to enter the U.S. market were required to conduct pharmacokinetic (PK) comparison studies directly against "U.S.-approved reference drugs." Under the revised guidelines, clinical data compared against reference drugs approved outside the U.S. can now be accepted to demonstrate equivalence.
Celltrion expects this measure alone could reduce overall clinical trial costs by up to 25% in the immuno-oncology sector, where it is developing multiple products and reference drug costs are high.
The company analyzed that this regulatory easing will not simply result in cost savings but will serve as a strategic opportunity to expand "economies of scale" across its entire product portfolio. By concentrating resources saved through relaxed clinical requirements on additional pipeline development, the company can add products for small and mid-sized markets that were previously difficult to develop due to high clinical costs, accelerating mid-to-long-term product portfolio expansion.
A Celltrion official emphasized, "Based on the reduced costs, we will further expand our pipeline to achieve economies of scale and leap forward as a big pharma with unparalleled cost competitiveness in the global market."
