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

    Basic Details

    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.


    Catherine M. Lockhart, Cara L. McDermott, Thomas Felix, Nancy D. Lin, Mark J. Cziraky, Aaron B. Mendelsohn, Jeffrey S. Brown