In the recent news cycles dominated by catastrophic hurricanes and earthquakes, not to mention the prospect of nuclear war, some may have missed an important drug approval—the first biosimilar approved in the United States for treating cancer. In mid-September, the FDA approved bevacizumab-awwb, a biosimilar medication to bevacizumab (Avastin) for treating adults with metastatic colorectal and renal cancers, glioblastomas, and cervical and nonsquamous non–small-cell lung cancers.
This event is important on several levels, both clinical and financial. Marking the first biosimilar approval, the drug has the potential to make inroads into reducing often-exorbitant costs associated with oncology treatments, a subject that made news headlines during last year’s presidential election season.
As FDA Commissioner Scott Gottlieb, MD, put it, “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.” (A biosimilar drug is highly similar to an already-approved biological product and has no clinically meaningful differences.)
Biosimilar approvals appear to be picking up steam. Bevacizumab-awwb’s approval comes on the heels of other biosimilar drug approvals that target noncancer illnesses. In late August, the FDA approved the sixth medication in this class, adalimumab-adbm, a biosimilar to Humira. Before that, the most recent biosimilar approval in the U.S. was for infliximab-abda, an IV infusion for multiple indications.
Author Clarence Moore, PharmD, BCPS, BCOP, cautioned in his article “Biosimilars in Oncology” in our February 2017 Specialty Pharmacy, Oncology & Hematology Supplement, “As biosimilar mAbs [monoclonal antibodies] begin to enter the field of oncology, it is increasingly important for cancer practitioners to understand the biosimilar development and evaluation process of data in order to make an informed decision and incorporate these medications into clinical practice. With a true biosimilar to the reference product, it is expected that therapeutic effects such as efficacy, safety, and immunogenicity are similar.”
FDA Commissioner Gottlieb also sounded sanguine about biosimilars’ presumed efficacy. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly,” he said, “through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”
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