Clinical Trials

Date: 2018-08-16

Type of information: Submission of a clinical trial application

phase: 3

Announcement: submission of a clinical trial application

Company: Celltrion Healthcare (South Korea)

Product: CT-P16 (biosimilar version of bevacizumab - Avastin®)

Action mechanism:

biosimilar/monoclonal antibody. CT-P16 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Avastin® (bevacizumab). Avastin® is approved in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous lung cancer in addition to metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.

Disease: breast cancer

Therapeutic area: Cancer - Oncology

Country: Portugal

Trial details:

Latest news:

• On August 16, 2018, Celltrion announced that the company is set to launch global Phase 3 clinical trial for its bevacizumab biosimilar ‘CT-P16’ for the treatment of cancer. Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently submitted its Clinical Trial Application for Phase 3 clinical study to the National Authority of Medicines and Health Products, I.P. (Infarmed) of Portugal.
Beginning with Portugal, Celltrion is set to conduct Phase 3 clinical trial for CT-P16 in about 150 sites in some 20 nations across Europe, Asia and South America.