Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Abstract

Almost two decades since biosimilars arrived, we still await their broader adoption, as anticipated. The roadblocks to this adoption include the high amortized cost of goods due to regulatory burden, hurdles created by the distribution system, perception of safety and efficacy, and lack of focus by stakeholders on removing these roadblocks. In this paper, I analyze the source of these roadblocks and offer practical solutions to remove them. These efforts are needed to maximize the adoption of biosimilars to encourage the entry of 100+ biological molecules that can bring affordable healthcare direly missing today across the globe.

Keywords:

• biosimilars
• biosimilarity
• development cost
• regulatory planning
• accessibility
• affordability
• FDA
• EMA
• WHO
• MHRA

Disclosure

The author declares no conflict of interest.