Celltrion's 'Vegzelma' Approved for Sale in Australia... Expands to 39 Countries Globally

Celltrion recently announced on the 4th that it has obtained sales approval from the Australian Therapeutic Goods Administration (TGA) for Vegzelma, a biosimilar (biopharmaceutical generic) of Avastin (active ingredient bevacizumab).

Celltrion's anticancer biosimilar 'Vegzelma (generic name Bevacizumab)'
[Photo by Celltrion]

This Vegzelma sales approval covers the full-label indications for Avastin approved in Australia, including metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma.

In particular, with this approval, the number of commercialized products by Celltrion in Oceania is expected to increase to six. Since 2015, starting with 'Remsima' in Australia, Celltrion has consecutively obtained approvals for key products such as the anticancer drugs 'Herzuma' and 'Truxima' and the autoimmune disease treatment 'Uplima,' expanding its market presence in the Oceania region. Notably, Australia is one of the countries that has introduced biosimilar-friendly policies encouraging biosimilar prescriptions since 2018 to reduce medical expenses and improve patient access to biopharmaceuticals. With the addition of Vegzelma's approval, Celltrion has established a strong portfolio of anticancer antibody therapies alongside Herzuma and Truxima.

Since last year, Celltrion has actively prepared to expand its market share in the bevacizumab market by consecutively obtaining approvals for Vegzelma from major regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety. Including Australia, Vegzelma has now been approved in a total of 39 countries. Recently in the U.S., it has been listed on the formularies of numerous major private insurers, and including public insurance, it covers about 30% of the entire U.S. population, accelerating market expansion.

According to IQVIA, a global pharmaceutical market research firm, the global bevacizumab market size is estimated at $5.651 billion (approximately 7.465 trillion KRW).

A Celltrion official stated, “With this approval, we have strengthened our market competitiveness by establishing an anticancer antibody therapy trio consisting of Vegzelma, Herzuma, and Truxima in the biosimilar-friendly Oceania market, while also building a portfolio of six biosimilar products in total. We have recently completed the approval application for the Stelara biosimilar 'CT-P43,' and we expect our influence in the Oceania pharmaceutical market to grow even further.”

This content was produced with the assistance of AI translation services.