This past year, the COVID-19 pandemic continued to impact the practice of medicine and the dissemination of treatment advances presented in scientific forums. Adapting to these changes, organizations such as the American Society of Clinical Oncology (ASCO), the American Society of Hematology (ASH), and the European Society for Medical Oncology (ESMO) have adopted virtual formats that delivered cutting-edge research in the advancement of oncology care.
Virtual formats present several challenges in reaching intended audiences that the Year in Review series attempts to ameliorate by presenting effective and timely information about oncology treatment advances to clinicians engaged in cancer delivery and research. This edition of the Year in Review is focused on biosimilars, which are biological products that are highly similar to and have no clinically meaningful differences from existing, FDA-approved reference products in terms of purity, mechanism of action, potency, pharmacodynamics, pharmacokinetics, clinical efficacy, safety, and immunogenicity. Biosimilars have the potential to increase affordability and improve patient access to biologic drug therapies, as well as significantly alleviate the financial burden on healthcare systems. In this issue, we focus on data demonstrating equivalence between biosimilars and reference products, potential cost-savings, and real-world practice patterns.
Several biosimilars for patients with cancer continue to be developed. We provide an overview of presented data on the investigational trastuzumab biosimilars TX05 and SB3 and the bevacizumab biosimilars BCD-021 and MIL60 that have demonstrated bioequivalence to the originator in terms of efficacy, safety, and immunogenicity. Practice trends show real-world utilization of many of the biosimilars in patient populations with cancer as well as comparable efficacy and safety between the biosimilar and its originator in these settings. Real-world data confirmed that treatment with the trastuzumab biosimilar trastuzumab-anns was associated with an acceptable cardiac safety profile, even when switching from the trastuzumab reference product or combined with pertuzumab.
Simulation modeling data for cost-effectiveness demonstrates considerable cost-savings achieved by converting from a reference product to its biosimilar. The models may potentially create opportunities for reallocation of the cost-savings toward additional biosimilar cycles, anticancer therapies, or food/transport support. Such cost-savings could be allocated on a budget-neutral basis to provide additional chemotherapy-induced (febrile) neutropenia prophylaxis, antineoplastic treatments, and food/transportation support.
We are pleased to present the highlights of these topics.
Adam M. Brufsky, MD, PhD
Professor of Medicine
University of Pittsburgh School of Medicine