Prescriber Education, FDA Guidance May Be Keys to Promoting Biosimilar Adoption

May 20, 2019

Biosimilars Team

Prescriber education programs focusing on evidence from clinical switching studies, along with Food and Drug Administration (FDA) guidance on pharmacy-level substitution of reference biologics with biosimilars, may be the most promising strategies for overcoming barriers to biosimilar adoption, based on an October 2018 survey of 300 managed care and specialty pharmacy professionals. The survey study findings are available online ahead of print from the Journal of Managed Care & Specialty Pharmacy (JMCP) website.

The online survey presented 16 strategies for overcoming key barriers to biosimilar adoption. Using a 5-point scale, participants rated the likelihood that each strategy would assist in achieving the goals of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which established pathways for FDA approval of biosimilar products. Participants also rated the perceived difficulty in overcoming six barriers to biosimilar adoption. The survey concluded with an open-text item that asked participants to list three additional strategies for overcoming biosimilar adoption barriers.

Based on pooled percentages for ratings of “likely” and “extremely likely” to overcome barriers to biosimilar adoption, the highest-rated strategies were prescriber education about evidence from switching studies (91%) and FDA guidance on pharmacy-level substitution of biosimilars (90%). The lowest-rated strategies were using quotas to incentivize providers to prescribe biosimilars (40%) and requiring therapeutic drug monitoring for patients who switch to biosimilars (39%). One unexpected finding was the relatively low percentage of respondents (63%) who indicated that postmarketing surveillance and pharmacovigilance initiatives are likely or extremely likely to overcome barriers to biosimilar adoption.