Просмотр новости
Найдите то, что Вас интересует
Спутники
РН
SpaceX
Роскосмос
NASA
Celltrion Vegzelma Matches Original Drug in Study
Дата публикации: 14-08-2026 12:23:20
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
Основное содержимое страницы с новостью.
Celltrion Vegzelma (Provided by Celltrion)
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 pharmacokinetic analysis results of Vegzelma, a treatment for metastatic colorectal cancer and breast cancer, were published in ‘BioDrugs’, an international academic journal in the fields of biotechnology and pharmacology. This research was conducted in collaboration with a research team led by Professor Jang Min-jung of Yonsei University, and it is the result of integrating and analyzing two phase 1 clinical trials targeting healthy subjects and one phase 3 clinical trial targeting patients with non-squamous non-small cell lung cancer.
The research team built an ‘integrated phase 1 and 3 population pharmacokinetic model’ utilizing more than 8000 serum concentration data points secured from a total of 834 subjects. As a result of comparatively evaluating the pharmacokinetic parameters between Vegzelma and the original drug through this, the two products showed an equivalent level of characteristics.
In particular, it was confirmed that there were no clinically meaningful differences in major indicators such as ‘clearance’, which means the speed at which the drug is removed from the body, and ‘central volume of distribution’, which indicates the total amount of drug absorbed into major organs. Population pharmacokinetic modeling is a technique that precisely analyzes drug absorption and mechanism of action for each patient, and it is a trend that global pharmaceutical companies are actively adopting for comparative drug verification recently.
This research has significant meaning in that it successfully expanded the clinical evidence beyond simple equivalence proof. As global regulatory agencies have recently been simplifying biosimilar approval guidance, Celltrion plans to utilize this integrated research model as a major strategy to secure clinical competitiveness for its subsequent portfolio in the future.
Celltrion has established a policy to continuously accumulate academic data through low-cost, high-efficiency follow-up research without stopping at clinical data for approval. The company plans to present this to medical staff as multilateral prescribing evidence to increase reliability in the product and solidify its position in the global market.
Vegzelma is already showing a steep growth trend in major global markets. According to IQVIA, a pharmaceutical market research firm, the US market share of Vegzelma recorded 10.6% as of May this year, surpassing double digits for the first time since its launch. In the Japanese market, it is recording an overwhelming No. 1 position with a 64% share as of March this year.
Схожие новости
Классификация: Пресс-релизы. Схожих патентов: 0. Схожих новостей: 9. Тональность: 0. Информативность: 12.21. Источник: www.businesskorea.co.kr.