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The FDA has approved Jobevne, a biosimilar to Avastin, for IV use in a number of cancer types.
The FDA has approved Jobevne, a biosimilar to Avastin, for IV use in a number of cancer types.
The U.S. Food and Drug Administration has approved Jobevne (bevacizumab-nwgd), a biosimilar to Avastin (bevacizumab) for intravenous use in cancer types including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube or primary peritoneal cancer.
The approval — announced in a news release from Biocon Biologics Ltd., a subsidiary of Biocon Ltd. — is indicated for cancers including metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment and metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
Pharmacokinetics: study of how the drug is absorbed, distributed, metabolized and excreted in the body, providing insight into the drug's action and optimal dosing.
Immunogenicity: the ability of a substance containing antigens to provoke an immune response from the body.
Jobevne is also indicated for unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel chemotherapy as a first-line treatment as well as in recurrent glioblastoma in adults; metastatic renal cell carcinoma, in combination with interferon alfa and persistent, recurrent, or metastatic advanced cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
Additionally, it is indicated for epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by Jobevne as a single agent for stage 3 or 4 disease following initial surgical resection; with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens and in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Jobevne as a single agent, for platinum-sensitive recurrent disease.
The news release further notes that Jobevne is not indicated for the adjuvant, or postsurgical, treatment of colon cancer.
Jobevne, according to the news release, is a recombinant humanized monoclonal antibody, a vascular endothelial growth factor (VEGF) inhibitor designed to bind with VEGF and block the interaction with its receptors in order to prevent angiogenesis, or the formation of new blood vessels, thereby restricting blood supply to a tumor.
A biosimilar medication, as explained by the FDA on its website, is highly similar to a biologic medication already approved by the FDA and has no clinically meaningful differences from the original reference product, meaning patients can expect the same safety and effectiveness over the course of treatment. Biosimilars, the FDA notes on its website, can increase access to lifesaving medications at potentially lower costs.
The approval on Jobevne, according to the news release, was based on pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data confirming that Jobevne is highly similar to Avastin, with no clinically meaningful differences in pharmacokinetics, safety, efficacy and immunogenicity.
Biocon Biologics Ltd., as it noted in the news release, also markets bevacizumab in Europe and Canada under the name Abevmy, with those approvals having been issued in February 2021 and November 2021, respectively.
“The U.S. FDA approval of Jobevne is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio,” said Shreehas Tambe, CEO and managing director of Biocon Biologics Ltd., in the news release. “It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.”
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