Bio-Thera Solutions Files for EU Bevacizumab Approval

November 25, 2020

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

Bio-Thera Solutions of Guangzhou, China, has filed a marketing authorization application to the European Medicines Agency for approval of BAT1706, an investigational biosimilar candidate that references Avastin.

The company said it hopes to obtain authorization for all indications of the reference product in the European Union, Iceland, Norway, and Leichtenstein.

The application marks the first "ex-China" application for biosimilar approval, or approval application for a drug developed in China for marketing abroad.

"Bio-Thera intends to bring its pipeline of biosimilars and innovative therapies to patients around the world and this submission is an important step for extending the global reach of BAT1706," said Shengfeng Li, founder and CEO.

Bevacizumab targets vascular endothelial growth factor (VEGF) by blocking the binding of VEGF to its receptor and thereby reducing vascularization that supports the development of tumors.

The reference product is approved in Europe for colon and rectum cancer; metastatic breast cancer; non–small cell lung cancer; renal cell caner; epithelial ovarian, fallopian tube, and primary peritoneal cancer; and cervical cancer.

Bio-Thera also intends to seek regulatory approval in the United States, and a biologics license application filing is anticipated before the end of 2020, the company said.

The company has one already marketed biosimilar, Qletli, an adalimumab biosimilar, which has been authorized for distribution in China.