Abstract
Cancer therapy has evolved significantly with increased adoption of biologic agents ("biologics"). That evolution is especially true for her2 (human epidermal growth factor receptor-2)-positive breast cancer with the introduction of trastuzumab, a monoclonal antibody against the her2 receptor, which, in combination with chemotherapy, significantly improves survival in both metastatic and early disease. Although the efficacy of biologics is undeniable, their expense is a significant contributor to the increasing cost of cancer care. Across disease sites and indications, biosimilar agents are rapidly being developed with the goal of offering cost-effective alternatives to biologics. Biosimilars are pharmaceuticals whose molecular shape, efficacy, and safety are similar, but not identical, to those of the original product. Although these agents hold the potential to improve patient access, complexities in their production, evaluation, cost, and clinical application have raised questions among experts. Here, we review the landscape of biosimilar agents in oncology, with a focus on trastuzumab biosimilars. We discuss important considerations that must be made as these agents are introduced into routine cancer care.
Highlights
In recent years, cancer treatment has been revolutionized by the introduction of biologic agents (“biologics”)
Trastuzumab was subsequently added to the list in 2015, with the caveat that the petition for inclusion was based on the possibility of obtaining a lower-cost biosimilar product
The Heritage study, a phase iii study evaluating the biosimilar MYL-1401O combined with docetaxel in her2+ mbca, showed a noninferior orr of 69.6% compared with 64% with Herceptin–docetaxel, meeting the endpoint of equivalence
Summary
Cancer treatment has been revolutionized by the introduction of biologic agents (“biologics”). For biosimilars to be approved, Health Canada, the ema, and the U.S Food and Drug Administration (fda), require that the quality, activity, safety and efficacy of the new agent be comparable to those of the original agent (Table i).
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