Celltrion, led by CEO Woo Sung Kee, announced a significant milestone on September 4th as it received approval from the Australian Therapeutic Goods Administration (TGA) for its biosimilar 'Vegzelma,' containing the active ingredient Bevacizumab, also known as Avastin. This marks the sixth biosimilar approval granted in Australia and signifies a pivotal moment for Celltrion's presence in Oceania.

The approval for Vegzelma aligns with the full label indications previously granted to Avastin in Australia, encompassing metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, cervical cancer, epithelial ovarian, fallopian tube, and primary peritoneal cancer, as well as gestational trophoblastic tumors.

Celltrion, a leader in biosimilar innovation, foresees an expansion of its commercial offerings in Oceania to six products. This development solidifies Celltrion's influence and competitiveness on the continent, especially in Australia, known for its pro-biosimilar stance and supportive policies that further elevate Celltrion's prospects.

Since 2015, Celltrion has secured approvals for six products in Australia, commencing with 'Remsima' for autoimmune diseases, followed by 'Truxima' for blood cancer, 'Herzuma' for breast and stomach cancer, 'Remsima SC' for autoimmune diseases, 'Yuflyma,' and now 'Vegzelma' for metastatic colorectal cancer. The company underscores the establishment of a robust portfolio of anti-cancer monoclonal antibodies, complementing Herzuma and Truxima, thus enhancing its foothold in the Australian market.

Celltrion's strategic trajectory extends beyond Australia, with a focus on expanding the market share for Bevacizumab. Vegzelma's consecutive approvals are not limited to Australia but extend to major global markets, totaling 39 countries, including the United States, Europe, the United Kingdom, Japan, and South Korea. The global market size for Bevacizumab in 2022, as reported by IQVIA, a renowned pharmaceutical market research organization, amounted to approximately $5.65 billion (about 7.34 trillion won).

A representative from Celltrion emphasized the company's achievements, stating, "With this recent approval, we have not only established a trio of anticancer monoclonal antibodies, Vegzelma, Herzuma, and Truxima, in the bio-similar-friendly Oceania market but also fortified our market competitiveness with a total portfolio of six bio-similar products." They further added, "We have also recently completed the application for approval of our biosimilar 'CT-P43' for Stelara, further enhancing our presence in the pharmaceutical market in Oceania, and we look forward to the positive impact it will have.