BioDlink, a China-based pharmaceutical company, announced on Wednesday 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).
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 in close collaboration with BioDlink.
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). According to industry estimates, bevacizumab injection achieved global sales of USD8.5 billion in 2023.
"Cancer incidence is rising sharply, especially colorectal cancer, which has seen a global increase in early-onset cases in middle- and low-income countries," said Dr. Jun Liu, BioDlink CEO and executive director. "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."
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