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The FDA has approved bevacizumab-awwb as a biosimilar to bevacizumab for the treatment of multiple types of cancer. This is the first biosimilar approved in the U.S. for the treatment of cancer.

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"Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower health care costs and increase access to important therapies," said FDA Commissioner Scott Gottlieb, MD. "We'll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA's rigorous gold standard for safety and effectiveness."


This biosimilar is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney, and cervical cancers. Specifically, the approved indications include the following:


* Metastatic colorectal cancer, in combination with IV 5-fluorouracil-based chemotherapy for first- or second-line treatment. It is not indicated for the adjuvant treatment of surgically resected colorectal cancer.


* Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. It is not indicated for the adjuvant treatment of surgically resected colorectal cancer.


* Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent, or metastatic disease.


* Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.


* Metastatic renal cell carcinoma, in combination with interferon alfa.


* Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.



Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.


Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms, or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity, and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.


The FDA's approval is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates bevacizumab-awwb is biosimilar to bevacizumab. It has been approved as a biosimilar, not as an interchangeable product.


Common expected side effects include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.


Serious expected side effects include perforation or fistula, arterial and venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, proteinuria, infusion-related reactions, and ovarian failure.