Barriers and Facilitators to Conduct High‐Quality, Large‐Scale Safety and Comparative Effectiveness Research: The Biologics and Biosimilars Collective Intelligence Consortium Experience

In 2010, the Biologics Price Competition and Innovation Act was enacted in the United States to balance biologic innovation with fos­tering competition by establishing an abbreviated regulatory approval pathway for biosimilar drugs. Approved biosimilars are highly similar with no clinical difference to an already Food and Drug Administra­tion (FDA)-approved biologic drug (i.e., "reference"). The complexity of manufacturing biologic products, coupled with lack of understand­ing about regulatory approval requirements for biosimilars, has led to lingering uncertainty among patients and healthcare providers regarding the comparative safety and effectiveness of these products. Real-world evidence can help alleviate stakeholder concerns by providing additional evidence beyond trials required for registration. To address the need for real-world evidence, the Academy of Man­aged Care Pharmacy convened the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) in 2015 as a nonprofit, multistakeholder, collaborative, and scientific initiative for conducting rigorous postmarketing observational research to monitor the effec­tiveness and safety of biosimilars and novel biologics. BBCIC leverages infrastructure from the FDA Sentinel Initiative, including a distributed research network (DRN) with access to curated data formatted in the Sentinel Common Data Model, and publicly available Sentinel analytic tools. BBCIC is governed as a collaboration between industry part­ners, health plans, patients, and the research community focusing on transparency and stakeholder engagement.