Biosimilars Year in Review Introduction

Colleagues,

Due to the COVID-19 pandemic, the year 2020 has witnessed unprecedented changes in the practice of medicine and dissemination of treatment advances presented in scientific forums. Adapting to the changes, organizations such as the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), and the American College of Rheumatology (ACR) have adopted abbreviated virtual formats for their national and international meetings that delivered cutting-edge research in the advancement of oncology care. Recognizing the challenges of the virtual format in terms of reach and impact, we are bringing you the Year in Review series that seeks to synthesize the presented treatment advances and distribute the information to clinicians in a timely and effective manner to support cancer care 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 an existing, FDA-approved reference product 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.

The regulatory pathway for demonstration of biosimilarity between the biosimilar and reference product requires rigorous comparative stepwise evaluations, beginning with comprehensive analytical (structural and functional) characterization that forms the foundation for demonstrating biosimilarity, followed by preclinical animal studies, pharmacokinetic, pharmacodynamic, and immunogenicity studies in humans, and, if necessary, comparative clinical studies. The totality of evidence generated supports a demonstration of equivalence between the biosimilar and reference product. In this issue, we focus on data demonstrating equivalence between biosimilars and reference products, potential cost-savings, practice patterns, and ongoing challenges in the utilization of biosimilars.

The use of biosimilars is currently evolving as patents on several biologic drugs are expiring. Several biosimilars to approved biological products are continuing to be under development in different diseases, particularly oncology, rheumatic diseases, and inflammatory bowel diseases. We provide an overview of presented data on biosimilars, including trastuzumab, bevacizumab, and rituximab in oncology, and infliximab, etanercept, and adalimumab in rheumatic diseases and inflammatory bowel diseases. Emerging data on adherence patterns and practice trends show real-world utilization of many of the biosimilars, with no impact on disease activity or safety from switching from a reference product to a biosimilar. Simulation cost-savings modeling data indicate that cost-savings achieved by converting from a reference product to its biosimilar may potentially create opportunities for reallocation of the savings toward additional curative therapies.

We are pleased to present the highlights of these topics and more!

Gary H. Lyman, MD, MPH (Biostatistics), FASCO, FACP, FRCP
Professor, Public Health Sciences and Clinical Research Divisions, Fred Hutchinson Cancer Research Center
Senior Lead, Healthcare Quality and Policy, Hutchinson Institute for Cancer Outcomes Research
Professor of Medicine, Public Health, and Pharmacy, University of Washington School of Medicine

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