Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and PT Etana Biotechnologies Indonesia (“Etana”), jointly announced that the Indonesian Food and Drugs Authority (BPOM) has approved Bevagen® (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug, for five indications including metastatic colorectal cancer (mCRC), locally recurrent or metastatic triple negative breast cancer (mTNBC), advanced, metastatic, or recurrent non-small cell lung cancer(NSCLC), epithelial ovarian, fallopian tube, and primary peritoneal cancer (OC), and cervical cancer(CC). Etana will commercialize Bevagen® in Indonesia under the current licensing agreement with Innovent. Bevagen® will potentially be the first Chinese antibody drug to be marketed and locally produced in Southeast Asia.
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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, said “We are pleased that under the strategic collaboration with Etana, the approval of Bevagen® in Indonesia marked a meaningful step toward bringing Innovent’s innovative portfolio into the global market, benefitting patients globally. Pairing Etana’s commercial expertise in the local Indonesian market with Bevagen®’s clinical profile, high-quality production and relative affordability, we are confident that Bevagen® will launch to the market quickly and benefit many cancer patients.”
Nathan Tirtana, President Director of Etana said, “Etana appreciates the support of BPOM for approving Bevagen® for cancer patients in Indonesia. With this product, we believe we can provide better access to high quality and affordable biosimilar drug to meet the need of cancer patients in Indonesia. Our next step is to implement the technology transfer and local Bevagen® production in Indonesia, via collaboration with Innovent. According to GLOBOCAN 2020 data, breast cancer (16.6%), cervical cancer (9.2%), lung cancer (8.8%), liver cancer (5.4%) and colorectal cancer (4.4%) are the most frequent cancer types in Indonesia, and Bevagen® is approved for most of these indications.”
The approval of Bevagen® with the active ingredient Bevacizumab (humanised anti-VEGF monoclonal antibody) was granted by BPOM on 13 Jun 2022. Each single use Bevagen® vial contains 100mg of bevacizumab in 4mL vial (25mg/mL). The approval in Indonesia confirms that Bevagen® has complied with the drug safety and efficacy standards set by the Indonesian government, both in terms of product quality and production processes.