Bevacizumab Biosimilar, CT-P16, Ready for Phase 3 Trial

Celltrion has announced that it is ready to begin a phase 3 trial of its proposed bevacizumab biosimilar, CT-P16. The multicenter study will begin in Portugal and will eventually include approximately 150 sites in 20 nations in Europe, Asia, and South America.

The announcement of the phase 3 trial comes after a June 2018 completion of a phase 1 study in 144 volunteers that evaluated the pharmacokinetics, safety, and immunogenicity of the biosimilar in comparison to both US- and EU-approved reference Avastin.

Bevacizumab is an anti-vascular endothelial growth factor (anti-VEGF) drug that is approved to treat metastatic colorectal cancer, metastatic breast cancer, non—small cell lung cancer, and glioblastoma, but it has also been increasingly used off-label to treat diseases of the eye, including diabetic retinopathy and age-related macular degeneration, because its cost is significantly lower than that of anti-VEGF agents approved to treat eye disorders.

Click here to read more about anti-VEGF drugs.

Currently, 1 bevacizumab biosimilar—Amgen’s Mvasi—is approved in the United States and the European Union, though it has not launched in either territory and continues to be the subject of patent litigation. However, the field of potential biosimilars is growing, with drug makers including TOT Biopharm, JHL Biotech, and Mylan all currently engaged in clinical programs for their own biosimilars.

Celltrion’s announcement of its phase 3 study for CT-P16 follows closely on the heels of its announcement of concurrent phase 1 and phase 3 trials of another molecule, CT-P17, an adalimumab biosimilar referencing Humira. However, news of advancing clinical trials is dampened by ongoing problems with Celltrion’s manufacturing site where it produces its already authorized biosimilars, including its infliximab product, Inflectra.

The Incheon facility in the Republic of Korea recently received its second Form 483 from the FDA in under 1 year, and it has also received an FDA warning letter. While Celltrion called the latest Form 483’s observations “manageable and correctable,” it has not specified a timeline for remediating the issues.