Celltrion announced on Wednesday that it had received approval from the European Medicines Agency (EMA) on Monday to modify its Investigational New Drug (IND) application. This modification allows for a significant reduction in the number of registered patients for the global Phase 3 clinical trial of CT-P55, a biosimilar to Cosentyx (secukinumab).
The approved IND amendment enables Celltrion to substantially adjust its target patient pool from 375 to 153. This adjustment is the result of close collaboration with the EMA, aligning with European initiatives to streamline biosimilar development.
Celltrion anticipates that this change will not only cut development costs but also shorten the overall clinical trial duration by reducing both patient recruitment and enrollment numbers.
In recent months, both the EMA and the U.S. Food and Drug Administration (FDA) have been accelerating discussions on potentially waiving or simplifying Phase 3 trials for demonstrating efficacy equivalence.
These regulatory bodies are expected to allow such simplifications only when there is robust scientific evidence to support them. This approach could significantly reduce both the costs and timelines associated with clinical development.
Celltrion is currently making steady progress with its global Phase 3 trial, which aims to demonstrate the efficacy, safety, and equivalence of CT-P55 compared to the original drug, Cosentyx, in patients with plaque psoriasis.
Cosentyx, an interleukin (IL)-17A inhibitor, is used to treat autoimmune conditions including ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis. Its global sales are projected to reach approximately 6.668 billion USD by 2025. The drug’s substance patents are set to expire in January 2029 in the U.S. and July 2030 in Europe.
A spokesperson for Celltrion stated that this approval for its Phase 3 trial modification underscores the unique expertise in biosimilar development and the trust they’ve established with regulatory agencies. It is committed to maintaining the market leadership by adapting swiftly to global market shifts and reinvesting the cost savings into the pipeline, ensuring sustainable growth for the future.