FDA Moves to Facilitate Biosimilar Development
Alex Brill and Christy Robinson
Yesterday, the Food and Drug Administration (FDA) announced long-overdue reforms to the biosimilar approval process that will boost biosimilar development and competition in the United States. The most significant of these reforms is eliminating the requirement for comparative efficacy studies, which, as we wrote earlier this year, “generally do not meaningfully contribute to the demonstration of biosimilarity . . . [and] impose substantial costs that can deter development.”
According to FDA Commissioner Marty Makary, eliminating comparative efficacy studies will cut biosimilar development time in half and save companies $100 million in development costs.
The reforms announced yesterday also include finalizing draft guidance the FDA issued last year that will eliminate switching studies for biosimilar manufacturers seeking an interchangeability designation. This is a welcome development given the untapped savings potential for interchangeable biosimilars.
Six months ago, we looked at barriers to success in the second decade of US biosimilars and identified a range of impediments pertaining to access and utilization, development, and market entry and sustainability. The just announced FDA reforms represent an important step toward addressing these barriers.
