Celltrion's Vegzelma Integrated Phase 1 and 3 Analysis Published in International Journal

Analysis of Serum Concentration Data from 834 Participants and Over 8,000 Measurements
Pharmacokinetic Equivalence with the Original Reference Established
Comparison of Key Indicators Such as Clearance Rate and Central Volume of Distribution wit

Celltrion announced on August 14 that the integrated population pharmacokinetic analysis results from phase 1 and phase 3 clinical trials of Vegzelma (development code CT-P16), a biosimilar of Avastin (active ingredient: bevacizumab), have been published in the international academic journal 'Biodrugs.'

Celltrion Vegzelma product image. Celltrion

This study is an integrated analysis of data from two global phase 1 clinical studies conducted on healthy volunteers for product approval, and one global phase 3 clinical study conducted on patients with non-squamous non-small cell lung cancer (NSCLC). The study was carried out in academic-industry collaboration with Professor Jang Minjung's team at Yonsei University and used data from a total of 834 participants and over 8,000 serum concentration measurements.

The research team developed a population pharmacokinetic model based on the integrated data to compare the pharmacokinetic characteristics of Vegzelma and the original reference drugs used in the United States and Europe.

The analysis found that Vegzelma exhibited pharmacokinetic characteristics similar to those of the original reference drugs. There were no clinically significant differences in the primary indicators, such as clearance rate and central volume of distribution. Population pharmacokinetic analysis is a method that integrates clinical data from multiple patients and subjects to analyze the factors affecting the drug's concentration in the body and its pharmacokinetic profile.

Celltrion explained that the significance of this study lies in securing additional pharmacokinetic evidence by integrating clinical trial data for regulatory approval. The company plans to continue accumulating clinical and academic evidence for its biosimilars through additional follow-up clinical studies and analyses.

Vegzelma is increasing its market share in major markets such as the United States and Japan. According to Celltrion, as of May of this year, Vegzelma achieved a 10.6% market share in the United States, surpassing double digits for the first time since launch, and as of March this year, it maintained the number one position in Japan with a 64% market share.

A Celltrion official stated, "Even after obtaining regulatory approval, we will continue to secure clinical data to increase trust in product prescriptions and further expand our global market share."

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