Celltrion said Aug. 14 that an integrated population pharmacokinetic analysis of Vegzelma (development code CT-P16), a biosimilar of Avastin (bevacizumab) used to treat metastatic colorectal cancer and breast cancer, has been published in BioDrugs, an international journal specializing in biotechnology and pharmacology.
The study integrated data from two global Phase 1 trials conducted in healthy participants for regulatory approval and one global Phase 3 trial in patients with nonsquamous non-small cell lung cancer (NSCLC). The research was conducted in collaboration with a research team led by Chang-min Jang, a professor at Yonsei University.
Based on data from a total of 834 participants and more than 8,000 serum concentration measurements, the researchers developed an integrated population pharmacokinetic model using data from the Phase 1 and Phase 3 trials to compare the pharmacokinetic parameters of Vegzelma with those of the reference drug.
The results showed that Vegzelma had pharmacokinetic characteristics comparable to those of the reference drug marketed in the United States and Europe, with no clinically meaningful differences in clearance and central volume of distribution, two key pharmacokinetic parameters.
Clearance is a measure of the rate at which a drug is removed from the bloodstream over a given period and is used to assess how quickly a drug is eliminated from the body. Central volume of distribution refers to the extent to which an administered drug is distributed within the central compartment, including the blood and highly perfused tissues.
Population pharmacokinetic modeling is a technique that uses clinical data to analyze in detail how drugs are absorbed, distributed and act within the body across individual patients. Global pharmaceutical companies are also actively adopting the technology for drug development and comparative evaluations.
Celltrion said the study is significant because it demonstrates how the application of the analysis technique can extend clinical evidence beyond simply demonstrating equivalence.
In particular, as major global regulatory agencies have recently moved toward streamlining their biosimilar approval guidelines, Celltrion expects the integrated research model to serve as a key strategy for securing differentiated clinical competitiveness across its future portfolio.
The company plans to continue accumulating academic data through cost-effective follow-up clinical research rather than limiting its efforts to Phase 1 clinical data submitted for regulatory approval. Celltrion said it will use the data as additional prescribing evidence for health care professionals to strengthen confidence in its products and accelerate expansion of their global prescription market share.