China-based Innovent Biologics Inc. (HKG: 1801) has announced receiving indication approvals from Indonesia’s Badan Pengawas Obat dan Makanan (BPOM) for its Bevagen (bevacizumab), a biosimilar version of Avastin. This approval marks a significant milestone for Innovent as it expands its market presence in Southeast Asia.
Approved Indications
Innovent’s bevacizumab has been approved to treat several cancers, including metastatic colorectal cancer, metastatic triple-negative breast cancer, advanced non-small cell lung cancer, ovarian cancer, and cervical cancer. These approvals are based on robust clinical data demonstrating the safety and efficacy of Bevagen in these indications.
Strategic Partnership
In a strategic move in January 2021, Innovent licensed the commercialization rights of its bevacizumab biosimilar to PT Etana Biotechnologies Indonesia. This partnership leverages Etana’s local expertise and market knowledge to ensure effective distribution and commercialization of Bevagen across Indonesia.
Market Background
Roche’s originator Avastin first gained approval in China in February 2010, with its patent expiring in 2018. Innovent’s bevacizumab became the second biosimilar to receive approval in China and has since obtained marketing approvals for multiple indications, including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, advanced hepatocellular carcinoma, ovarian cancer, and cervical cancer.-Fineline Info & Tech
