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Biosimilars Month in Review: December 2023

The biosimilars month in review highlights interviews with experts discussing the cost-saving potential of increased biosimilars uptake in the US, a recent US Food and Drug Administration (FDA) approval, and the impact of a mandatory switch to an adalimumab biosimilar in New Zealand.

BioBlast w/e 08 Dec 23

FDA Issues CRL For Biocon/Viatris Bevacizumab Biosimilar - Life Sciences, Biotechnology & Nanotechnology

On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab)

Innovent and Etana Jointly Announce the Approval of Bevagen® (Bevacizumab Biosimilar) by the Indonesian Food and Drugs Authority (BPOM)

Innovent and Etana Jointly Announce the Approval of Bevagen® (Bevacizumab Biosimilar) by the Indonesian Food and Drugs Authority (BPOM)
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Innovent and Etana Jointly Announce the Approval of Bevagen (Bevacizumab Biosimilar) by the Indonesian Food and Drugs Authority (BPOM)

SAN FRANCISCO and SUZHOU, China, June 14, 2022 /PRNewswire/ Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), 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"), today 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

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