Samsung Bioepis and Celltrion are competing to become the first Korean company to develop a biosimilar to “Avastin,” a blockbustger drug for colorectal cancer developed by global pharmaceutical company Roche.
The two companies previously competed over the development of a biosimilar to “Herceptin,” another blockbuster drug developed by Roche for treatment of some types of breast cancer, oesophageal cancer and stomach cancer.
According to industry sources on October 10, Celltrion filed earlier this month an application for a phase 3 global clinical trial of Avastin biosimilar “CT-P16” with the Clinical Trials, which is a clinical registration agency under the U.S. National Institutes of Health (NIH). Last June, Celltrion entered the phase 1 clinical trial of CT-P16 in Korea and started a phase 3 clinical trial in Europe in August.
Avastin is a hugely successful anti-cancer drug. Last year, it placed 7th in the global drug sales ranking by posting US$7.89 billion (about 8 trillion won). Sales of the drug have been continuously growing as its treatment areas have been expanded to breast cancer, lung cancer, and glioblastoma.
Global pharmaceutical companies have been competing to produce an Avastin biosimilar as Roche’s U.S. and European patents are to expire in 2019 and 2020, respectively.
Amgen and Allergan first developed “Mvasi” and obtained an approval from the U.S. and Europe. Recently, Pfizer has completed a phase 3 clinical trial of a biosimilar, while Samsung Bioepis and Boehringer Ingelheim are currently conducting phase 3 clinical trials. The four companies are expected to release their products at the same time.
Samsung Bioepis is confident of becoming the first Korean company to produce an Avastin biosimilar because it has entered the phase 3 clinical trial of “SB8” ahead of Celltrion’s CT-P16. Samsung Bioepis won the previous race against Celltrion over the development of a biosimilar to Herceptin.
An industry official said, "The patents for previous biopharmaceuticals expired first in Europe, but the patent of Avastin will expire first in the U.S., which is the biggest global pharmaceutical market, and this is why all of the global biopharmaceutical companies are showing a big interest in Avastin.”