Celltrion to Present Phase 3 Clinical Trial Results of Two Biosimilars at European Conference in September

Stellara Biosimilar Presented at European Academy of Dermatology
'Vegzelma' Phase 3 Follow-up Results Released at ESMO

[Asia Economy Reporter Lee Gwan-joo] Celltrion will consecutively disclose the Phase 3 clinical trial results of two follow-up biosimilars at European conferences next month. This strategy aims to secure next-generation growth engines amid the remarkable growth of RemsimaSC in the European market.

On the 30th, Celltrion announced that it will present the Phase 3 clinical trial results of the Stelara biosimilar 'CT-P43' (generic name ustekinumab) and the Avastin biosimilar 'Vegzelma' (generic name bevacizumab) at European conferences next month.

First, at the European Academy of Dermatology and Venereology (EADV) conference held in Milan, Italy from the 7th to the 10th of next month, the 28-week global Phase 3 results demonstrating the safety and efficacy of CT-P43 in patients with plaque psoriasis will be presented.

The original drug Stelara, of which CT-P43 is a biosimilar, was developed by Janssen as a treatment for autoimmune diseases such as psoriasis, Crohn's disease, and ulcerative colitis, and recorded blockbuster sales of approximately 12 trillion KRW last year alone.

Additionally, at the European Society for Medical Oncology (ESMO) conference held in Paris, France from the 9th to the 13th of next month, Celltrion will present the follow-up global Phase 3 results of Vegzelma, which recently obtained marketing authorization in Europe. Celltrion plans to disclose data confirming similarity in survival analysis and safety results between Vegzelma and the original drug in comparative clinical trials.

Vegzelma is an anticancer agent developed by Celltrion following the blood cancer treatment 'Truxima' and the breast and gastric cancer treatment 'Herzuma.' On the 18th of last month (local time), the European Commission (EC) granted marketing authorization for Vegzelma for all indications approved for Avastin, including metastatic colorectal cancer and non-small cell lung cancer. Prior to obtaining approval for Vegzelma, Celltrion completed a global patent agreement with the original drug developer, and Celltrion Healthcare, responsible for overseas sales of Vegzelma, plans to launch Vegzelma in Europe in the second half of this year.

The original drug Avastin, of which Vegzelma is a biosimilar, was developed by Roche as a blockbuster anticancer agent used to treat non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, glioblastoma, and more. According to IQVIA, the global bevacizumab market size was $6.413 billion (approximately 8.54 trillion KRW) last year.

A Celltrion official stated, “Thanks to the success of Remsima and Truxima, which are outselling the original drugs in the European market, and the steep growth of RemsimaSC, our next-generation growth engine, Celltrion is leading the biosimilar market in Europe. We will spare no effort at the group level to ensure that Vegzelma and CT-P43, the next-generation growth engines introduced at the European conferences in September, are commercialized early and made available to patients in Europe.”

As of the first quarter of this year, Remsima holds a 52.3% market share in Europe, surpassing the original drug, while Truxima has secured a 26.5% market share, also exceeding that of the original drug.

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