Celltrion's Vegzelma pharmacokinetics study published in international journal

Celltrion announced Friday that results from an integrated population pharmacokinetics analysis of its Phase 1 and Phase 3 trials for Vegzelma (development code CT-P16) — a biosimilar of Avastin (bevacizumab) used to treat metastatic colorectal cancer and breast cancer — have been published in the international peer-reviewed journal BioDrugs.

The study was conducted in collaboration with a research team led by Professor Jang Min-jeong of Yonsei University, integrating data from two Phase 1 trials in healthy volunteers and one Phase 3 trial in patients with non-squamous non-small cell lung cancer. Researchers developed and evaluated a pharmacokinetic model based on data from 834 subjects and more than 8,000 serum concentration measurements.

The analysis found that Vegzelma demonstrated pharmacokinetic characteristics equivalent to the originator products approved in the United States and Europe, with no clinically meaningful differences in key indicators such as clearance rate and central volume of distribution.

Celltrion views the study as a significant example of successfully expanding the clinical evidence base beyond initial marketing authorization through low-cost, high-efficiency follow-on analysis. As major global regulators move to streamline biosimilar approval guidelines, accumulating such post-authorization academic data is expected to become a core strategy for strengthening the clinical competitiveness of its future pipeline.

According to IQVIA and other global market research firms, Vegzelma held a 10.6 percent share of the US market as of May, surpassing double digits for the first time since its launch. In Japan, the product commanded a 64 percent market share as of March, maintaining its position as the clear No. 1.

Celltrion said the journal publication is significant because it goes beyond completing clinical trials for regulatory approval. By continuously providing healthcare professionals at the point of prescription with substantive scientific data, the company said it has built strong barriers to entry and brand credibility amid intensifying global biosimilar competition.

"Even as the global regulatory environment becomes more streamlined, we will continue to build an extensive body of clinical data to strengthen confidence in prescribing our products and actively expand our share in global markets," a Celltrion official said.