China-based BioDlink has announced that its self-developed bevacizumab injection biosimilar has received marketing approval from Colombia’s National Institute for Surveillance of Medicines and Foods (INVIMA) and Pakistan’s Drug Regulatory Authority of Pakistan (DRAP).

This follows its recent approval in Nigeria, marking key regulatory milestones in high-need emerging markets.

Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), is widely used in the treatment of various cancers, including metastatic colorectal cancer (mCRC) and metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC).

Colombia and Pakistan are reportedly seeing an increase in the incidence of colorectal cancer. The launch of bevacizumab injection aims to lower the cost of treatment for both public health systems and patients, while maintaining rigorous global quality standards.

“Cancer incidence is rising sharply, especially colorectal cancer, which has seen a global increase in early-onset cases in middle- and low?income countries. With our partnership with Kexing Biopharm, we are committed to serving South American and other emerging markets and combat colorectal and lung cancers, the top two leading causes of cancer-related deaths worldwide,” said Dr. Jun Liu, CEO and Executive Director of BioDlink.

BioDlink, in partnership with Kexing BioPharm, is fast-tracking access to high-quality oncology biosimilars in underserved regions.

Following GMP certification in China, Colombia, Brazil, Argentina, Egypt, Indonesia and Pakistan, Kexing BioPharm, the global licensee for bevacizumab injection in emerging markets, has initiated regulatory filings in 35 countries.  

Since signing an international commercialization agreement in early 2022, the two companies have achieved an efficient closed-loop “R and D-manufacturing-access” model. BioDlink focuses on ensuring international manufacturing and supply chain robustness, while Kexing BioPharm leverages its global channels to drive localized market access efficiently.

They share an operational philosophy of “leading with quality and building on compliance” to focus on emerging markets such as South America, South Asia, Southeast Asia, and Africa. Both companies look forward to deepening their global collaboration to fulfill a shared mission of advancing global healthcare.  

BioDlink operates 50,000 square meters of manufacturing facilities, which have passed EU-QP inspection for antibody drugs and ADCs five times in four years, each with zero defects.

The company has delivered over 100 clinical projects covering development, clinical filings, and manufacturing services in markets worldwide, including Europe and the US.