Celltrion Vegzelma Matches Original Drug in Study
The anticancer drug ‘Vegzelma (ingredient name bevacizumab)’ developed by Celltrion objectively proved its pharmacokinetic equivalence to the original drug through research results analyzing integrated global clinical data.Celltrion announced on August 14 that the integrated phase 1 and 3 population
Celltrion's Vegzelma, an anticancer drug containing bevacizumab, demonstrated pharmacokinetic equivalence to the original drug through a comprehensive analysis of global clinical data. This research, published in the international journal BioDrugs, was conducted in collaboration with Professor Jang Min-jung's team from Yonsei University.
The study integrated data from over 8000 serum concentration points from 834 subjects across Phase 1 and Phase 3 trials. The integrated phase 1 and 3 population pharmacokinetic model revealed that Vegzelma and the original drug exhibited equivalent pharmacokinetic parameters, including clearance and central volume of distribution.
This finding indicates a comparable removal speed and drug absorption into major organs, with no clinically significant differences. The research expands clinical evidence beyond mere equivalence proof, aligning with the trend of global pharmaceutical companies adopting population pharmacokinetic modeling for comparative drug verification.
Celltrion aims to leverage this integrated research model to enhance clinical competitiveness for future products. With the simplification of biosimilar approval guidance by global regulatory agencies, Celltrion plans to use this research as a strategic approach to secure clinical advantages. The company's policy includes continuous accumulation of academic data through cost-effective, efficient follow-up research, aiming to provide medical staff with multilateral prescribing evidence to bolster product reliability and solidify its global market position.
Vegzelma has witnessed a rapid growth in global markets, achieving a 10.6% market share in the US and maintaining an overwhelming 64% market dominance in Japan as of March 2023.
Written by urgent.news from BusinessKorea's reporting — not their text. Machine-written — it may contain errors, so check the original before relying on it.
