The Clinical and Economic Value of Follow-on Biologics: Biosimilars, Biobetters, and Bioparallels.

Abstract

The advent of biosimilars into the market of biologic treatments less than 20 years ago in Europe and about 10 years ago in the United States heralded a period of rapid and profound changes in biological therapies. While biosimilars where the first disruptors to the biologics market and some lingering concerns have been addressed, they have since been joined by biobetters and bioparallels in a powerful aggregate of follow-on biologics (FOB) competing with originators biologics. Biobetters are drugs derived from existing biological agents, either by design or by coincidence, with improved pharmacological properties or outcomes. Bioparallels are distinct biologic agents in established classes of biological therapeutics (for instance, Programmed Death 1 (PD-1) inhibitors) that mainly compete on price without the burden of demonstrating equivalence in efficacy and safety. Lingering clinical concerns about biosimilars have been addressed. The economic dynamics of a biologics market that includes lower-priced FOBs continues to be demonstrated, especially how the cost-efficiencies from treatment with FOBs enable expanded patient access to and patient equity in biological therapy on a budget-neutral basis. However, this must be considered within a broader context of potential excess FOB capacity in countries with relatively well-funded healthcare systems, the commoditization of FOBs, and associated downward pricing pressures. Positively, however, is how this excess FOB capacity can be parlayed into increased access to biological therapeutics in low- and middle-income countries.