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Duodenoscope Design Aimed at Infection Prevention.

The FDA has approved the country’s first biosimilar for adults with cancer. Bevacizumab-awwb, which will be marketed as Mvasi, has been approved to treat the same types of cancers as its reference product, bevacizumab, which is sold as Avastin. The drug is a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF). By blocking VEGF’s interaction with its receptors, bevacizumab-awwb prevents the development of new blood vessels that solid tumors need to thrive. Bevacizumab-awwb and bevacizumab are from different manufacturers that use their own unique cell line and proprietary processes. Differences between the 2 drugs aren’t clinically meaningful in terms of safety, purity, and potency. In a statement, FDA Commissioner Scott Gottlieb, MD, said new biosimilar development, especially for diseases with high-cost treatments, “is an important way to help spur competition that can lower health care costs and increase access to important therapies.” Bevacizumab-awwb was approved for administration with chemotherapy for certain patients with metastatic colon cancer, nonsquamous non–small cell lung cancer, and cervical cancer. The drug also is approved in combination with interferon alfa for patients with metastatic renal cell cancer and following prior therapy for patients with progressive glioblastoma. The FDA said its approval was based on a 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 show bevacizumab-awwb is biosimilar to bevacizumab. Common adverse events include epistaxis, headache, hypertension, rhinitis, proteinuria, dry skin, rectal hemorrhage, taste alteration, lacrimation disorder, back pain, and skin irritation. The drug also can cause fistula formation, arterial and venous thromboembolic events, posterior reversible encephalopathy syndrome, and ovarian failure. In addition, bevacizumab-awwb carries a boxed warning alerting clinicians and patients to the increased risk of gastrointestinal perforation, surgery and woundhealing complications, and hemorrhage.