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.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.