Market Overview

Celltrion Begins Global Phase 3 Clinical Trial for Its Bevacizumab Biosimilar 'CT-P16'

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  • Completed Phase 1 clinical trial in June, planning to launch Phase
    3 clinical trial across 20 nations beginning with Portugal

Celltrion,
Inc.
(KRX:068270) 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.

Meanwhile, Roche's Avastin®, the originator of CT-P16, is a
therapeutic anti-cancer drug for the treatment of metastatic colorectal
cancer, metastatic breast cancer, non-small cell lung cancer, and
glioblastoma. It last year recorded global sales of about USD 6.7 billion1,
making it blockbuster medicine.

"We are successfully conducting the clinical trial for the bevacizumab
biosimilar ‘CT-P16' as planned. We will secure the competitiveness for
CT-P16 compared with its competitive biosimilars." says an official of
Celltrion.

1 Source: Roche
Financial Report 2017

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading
biopharmaceutical company, specializing in research, development and
manufacture of biosimilar and innovative drugs. Celltrion strives to
provide more affordable biosimilar mAbs to patients who previously had
limited access to advanced therapeutics. Celltrion received FDA and EC's
approval for INFLECTRA® and Remsima®, respectively, which is the world's
first mAb biosimilar to receive approval from a regulatory agency in a
developed country. For more information, visit www.celltrion.com.

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