BBCIC

The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a research organization focused on advancing the development and understanding of biosimilars. Established in 2015 by the Academy of Managed Care Pharmacy, BBCIC addresses the need for more evidence regarding novel biologics, biosimilars, and related products. The consortium employs a transparent, science-driven approach to its research projects, which aim to improve the regulatory science surrounding biosimilar drugs.

BBCIC's work primarily involves leveraging real-world data (RWD) from medical claims and electronic health records to produce real-world evidence (RWE). This approach utilizes the vast amounts of digital healthcare information available, combined with advanced big-data analysis techniques, to enhance the development and review processes for biosimilars. The consortium's research efforts are particularly focused on identifying opportunities and challenges in using foreign real-world data to accelerate the approval process for biosimilars in the US.

In October 2022, BBCIC was awarded a USD 1.3 million grant from the FDA to fund a study titled "Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence." This study aims to ensure the safety, effectiveness, and reliability of biosimilars using RWD and RWE. In October 2023, the FDA awarded BBCIC an additional USD 1.4 million grant to support a new study that will examine the use of real-world data from the US, Italy, and Denmark to create recommendations for the FDA on addressing issues related to the use of international data in its regulatory decision-making process for biosimilars.

Key customers and partnerships

BBCIC collaborates with various academic institutions for its research projects. The consortium's latest study involves primary investigators from the University of Verona and the University of Southern Denmark, demonstrating its international partnerships in the field of biosimilar research.