Celltrion starts Phase 3 clinical trial for its CT-P16 biosimilar


Celltrion, Inc., a biopharmaceutical company from South Korea is set to launch Phase 3 clinical trial for its CT-P16, an Avastin biosimilar that treats colorectal cancer.

The Phase 3 trial will commence across 20 nations, beginning with Portugal. The company further plans to apply for clinical trials to regulatory agencies in Europe, Latin America, and other countries and will conduct phase 3 clinical trials for CT-P16 at about 150 sites in 20 countries.

Celltrion has completed clinical trials for the safety and pharmacokinetics evaluation of ‘CT-P16’ in Korea last year. Recently, it has applied for Phase 3 clinical trials to the National Authority of Medicines and Health Products, I.P. of Portugal.

Avastin therapy recorded sales of $6.6 billion

The original product of CT-P16 biosimilar, Avastin is used for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma. The Avastin therapy recorded the sales of $6.6 billion last year.

Biosimilars are laboratory-generated clones of high-priced Biologics, but the exact replication is impossible due to minute differences in the end products. Having the same structure as their parent biologics, biosimilars provide the same pharmaceutical effects at affordable prices, giving a better access to medical treatments for patients. Biosimilars are the new model of therapeutic agents that has revolutionized the social economy.

A company official said, “Celltrion is proceeding smoothly with the planned schedule for CT-P16,” He further added, “CT-P16 plans to secure differentiated competitiveness compared its competitors.”

Celltrion also applied for the clinical trials for its high-concentration formulated, adalimumab biosimilar, CT-P17 to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. CT-P17 is a biosimilar of Humira, which is a therapeutic biopharmaceutical for the treatment of rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, and ankylosing spondylitis.