Bio-Thera's Avastin Biosimilar Application Accepted by NMPA

Guangzhou, China-based Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has accepted a biologics license application (BLA) for its bevacizumab biosimilar (BAT1706).

Bio-Thera Solutions is seeking to commercially license the product referencing Genentech’s Avastin for all approved indications of the reference product in China, including advanced, metastatic, or relapsed non—small cell lung cancer, and metastatic colorectal cancer.

"Lung cancer and colorectal cancer are high-risk cancers, and patients need safe, effective, and affordable treatment drugs. BAT1706, developed in accordance with NMPA, FDA, and [European Medicines Agency] drug regulations, will provide a high-quality, low-cost treatment option for patients worldwide," Li Shengfeng, PhD, founder and CEO of Bio-Thera Solutions, said in a statement.

So far, BAT1706 has not been approved for marketing in any country.

BAT1706 demonstrated similar pharmacokinetics, efficacy, and safety compared with reference bevacizumab in a series of preclinical and clinical comparison studies.

Bevacizumab is a humanized monoclonal antibody (mAb) used to target vascular endothelial growth factor (VEGF) by binding to VEGF and blocking the binding of VEGF to its receptors. As a result, neovascularization is reduced, there is a degradation of existing blood vessels and tumor growth is inhibited.

Bio-Thera’s Growing Biosimilar Pipeline

BAT1706 is the second proposed biosimilar from Bio-Thera Solutions with positive phase 3 study results. Its first biosimlar, Qletli, a biosimilar adalimumab (Humira), received marketing approval and launched on the Chinese market in January 2020.

Bio-Thera Solutions is currently conducting phase 1 trials for its ustekinumab biosimilar (BAT2206) and its golimumab biosimilar (BAT2506). The company is also pursuing biosimilar versions of tocilizumab (Actemra) and secukinumab (Cosentyx) among others.

Increased Bevacizumab Competition

Recently, the NMPA approved Innovent Biologics’ bevacizumab biosimilar, Byvasda for all Chinese indications of the reference product.

Currently, lung cancer has the highest incidence and mortality rate in China among all malignant tumor types, with more than 770,000 newly diagnosed patients and 690,000 deaths in 2018, according to a report from the World Health Organization's International Agency for Cancer Research.