A multinational group of researchers conducted a systematic review of the real-world data collected when patients taking one biosimilar switch to another biosimilar for the same reference product. They assessed 626 reports of biosimilar switching, which were screened for duplication and validity, resulted in a comprehensive evaluation of 23 peer-reviewed articles and abstracts, comprising 3,657 patients.
The research, led by Hillel Cohen, PhD, Executive Director, Scientific Affairs, Sandoz, and published in BioDrugs, has significant implications for the U.S. biosimilar industry. As the general population changes health plans or insurer over the course of time (owing to costs, relocation, employer preference, etc), these payers vary in their formulary coverage of reference and biosimilar products. A patient taking an infliximab biosimilar, such as Inflectra®, may find that they will need to switch to Renflexis® in the following year to ensure the affordability of the medication. Therefore, a key underpinning of the success of the biosimilar industry is that switching between biosimilars for the same reference product should not cause significant loss of efficacy or a different side effect profile, including important changes in immunogenicity.
The research covered searchable items through December 2021 on multiple common medical publishing databases (including Biosis, Embase, MEDLINE, and Cochrane Database of Systematic Reviews). Building upon previous research by Barbier and colleagues, publications were evaluated for effectiveness and/or safety data linked to switching from one biosimilar to another, and had to meet stringent data requirements to be included in the review. Sixteen reports assessed the effects of switching between biosimilar infliximabs, three focused on adalimumab biosimilars, two on etanercept, and one on rituximab (on its oncology indications only).
“Within the limitations of this systematic review, available data suggests that biosimilar-to-biosimilar switching is a safe and effective clinical practice, although it is not covered by current health authority regulations or guidance,” concluded the authors. “No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date.”
The study did not include information on all variations of biosimilar-to-biosimilar switches because of the limited reports available. For example, available data for adalimumab biosimilars were limited to switches between Amgen’s and Samsung Bioepis’ agents. Once again, since the other adalimumab biosimilars were approved as physically and clinically equivalent to Humira®, there is little reason to believe that the conclusion would not be applicable to other switches as well.
In an Email to BR&R, Dr. Cohen said, “All adalimumab biosimilars approved in the U.S. and EU have undergone an extensive regulatory evaluation and approval process proving they match the quality, safety, and efficacy of the reference medicine. Moreover, clinical and real-world evidence shows that patients can effectively and safely switch from the reference biologic to a biosimilar and experience the same clinical benefits. As such, there is no scientific reason to expect that there would be clinically relevant differences if there are switches among adalimumab biosimilars.”
He continued, “I anticipate additional biosimilar-to-biosimilar switching data will become available in the future, but I’m pleased that the results of this systematic review confirm that providers and patients should feel confident if they switch between biosimilars.”
In other biosimilar news…Prestige Pharma announced that it has reached an accord with India-based Intas Pharmaceuticals’ U.S. subsidiary, Accord Healthcare. After receiving regulatory approval, Accord will market HD204, a bevacizumab biosimilar that is currently undergoing phase 3 trials, in North America and Europe.
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