September 14, 2017—Today, the U.S. Food and Drug Administration approved bevacizumab-awwb as a biosimilar to reference bevacizumab for the treatment of certain colorectal, lung, kidney, cervical, and brain cancers in adult patients. Bevacizumab is a human monoclonal IgG1 antibody that binds to and inhibits vascular endothelial growth factor (VEGF). This approval marks the first time a biosimilar agent has been approved in the U.S. for the treatment of cancer.
“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 healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, MD in a statement. “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.”
Biosimilars are biological products—that is, a drug derived from a living organism, including humans, other animals, yeast, or other microorganisms. Approval of biosimilars require that equivalence to the reference product be established, based on data measuring safety, purity, and efficacy. Structural and functional characterization, animal study data, pharmacokinetic and pharmacodynamic data, and clinical immunogenicity, safety, and effectiveness data are all used to demonstrate biosimilarity.
Biosimilars are unique in their approval process as detailed in the Biologics Price Competition and Innovation (BPCI) Act of 2009, a part of the Affordable Care Act. Under the BPCI, a biosimilar is able to rely on clinical data from the reference drug for its approval, as long as equivalence is established. Bevacizumab-awwb is the seventh biosimilar agent approved since 2009, and the third this year.
Bevacizumab-awwb is approved for use in metastatic colorectal cancer in combination with 5-FU-based chemotherapy as a first- or second-line treatment and in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy in the second-line setting, following progression from a first-line bevacizumab-containing regimen. Bevacizumab-awwb is not approved for the adjuvant treatment of surgically resected CRC.
Bevacizumab-awwb is also approved for non-squamous NSCLC, in combination with carboplatin and paclitaxel in the first-line setting for patients with unresectable, locally advanced, recurrent, or metastatic disease.
Further, bevacizumab-awwb has been approved for use in patients with glioblastoma following progression; in metastatic renal cell carcinoma in combination with INF-α; and in cervical cancers that are persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or topotecan.
The FDA stresses that bevacizumab-awwb has been approved as a biosimilar, and not an interchangeable product. The FDA further emphasizes that health care professionals should review the label and prescribing information for bevacizumab-awwb for more detailed information regarding approved uses.
Jonathan A. Bell
Published Online: Thursday, September 14, 2017