In a recent publication in the Journal of Hematology Oncology Pharmacy, the authors conducted a review to gather and examine available data regarding clinical efficacy and adverse events associated with biosimilars compared with their reference products. This study focused on the available monoclonal antibodies commonly utilized in oncology care, including bevacizumab, rituximab, and trastuzumab, and available biosimilars prescribed as supportive care in oncology patients.
The authors wrote, “Monoclonal antibodies are a unique class of medications that use larger molecules with specific targets for the treatment of cancer. With drug patents expiring and biosimilar availability increasing, there is a need to determine if biosimilars offer similar benefits to the reference drugs without increasing the adverse events.”
The authors noted that there are currently four FDA-approved biosimilars to bevacizumab, and based on available data, there are no variances in efficacy or adverse effects between bevacizumab and its biosimilars. Additionally, there were no significant variances with regard to overall response rate (ORR), time to progression, or survival between bevacizumab and bevacizumab biosimilars in any of the trials.
The authors indicated that there are three biosimilars approved from rituximab, and the available data for rituximab biosimilars reveal that several trials exploring the use of rituximab biosimilars have demonstrated noninferiority to reference rituximab, primarily in the treatment of low-grade lymphoma. The ORRs, progression-free survival rates, and duration of response rates have been comparable between rituximab and rituximab biosimilars.
Furthermore, data available for trastuzumab and the five FDA-approved trastuzumab biosimilars have demonstrated noninferiority with one another in the previous trials, predominantly in the endpoints of response rates (i.e., pathologic complete response and ORR). In addition, four of the five biosimilars available have been assessed for survival. Clinical trial data reveal that the trastuzumab biosimilars have demonstrated comparable survival to the trastuzumab reference product in breast cancer patients.
The authors wrote, “To date, all biosimilar comparison trials of approved biosimilars have shown at least noninferiority in efficacy and adverse events between the biosimilar and reference drug for the five currently available monoclonal antibodies with biosimilars.”
After conducting their review, the authors indicated that based on the available data, there are no apparent variances between reference drugs and available biosimilars used in oncology care with regard to adverse events and efficacy. The authors also noted that pharmacists, as the medication experts on the healthcare team, are uniquely positioned to recognize and address misconceptions about biosimilars.
The authors indicated that educating providers and patients about biosimilars can diminish hesitation about using biosimilars in both groups and ensure that prescribers and patients have confidence that the prescribed medications are working while sustaining cost savings.
The authors concluded, “The increased use of biosimilars is feasible with education and P&T [pharmacy-and-therapy]-approved buy-in, which can lead to the rapid implementation of biosimilars and a subsequent decrease in cost to health systems.”
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