The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) has received a major grant from the Food & Drug Administration (FDA) in support of biosimilars research.
The award provides $1.3 million over two years for a new BBCIC study focused on increasing the efficiency of biosimilar drug development and review.
The study, “Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence,” reflects BBCIC’s commitment to evaluating the safety and effectiveness of biologics, including biosimilars, through the generation of reliable, real-world data (RWD) and real-world evidence (RWE).
“The challenges in using real-world data and the relevance of real-world evidence for regulatory decision-making about biosimilars is a major obstacle in the industry,” said Cate Lockhart, executive director of the BBCIC.
“I’m thrilled the FDA has selected our study for funding, as it will have important benefits for the research community at-large, providing analytical tools for tests of interchangeability and other regulatory questions.”
BBCIC’s study will leverage volumes of RWD produced by digital sharing and storage of healthcare information (for example medical claims and electronic health records). The high volume of this digital data, along with revolutions in big-data analysis, provide a new opportunity to use RWD to produce RWE that can improve the regulatory science around the development and review of biosimilar drugs.
The Academy of Managed Care Pharmacy (AMCP) established the BBCIC in 2015 to address anticipated needs for evidence generation in this evolving space. Biosimilars, which are less expensive, highly similar with no clinically meaningful difference, and independently developed versions of original biological medicines, are a focus of AMCP in advancing their mission to provide high-quality, cost-effective medications to patients nationwide.
The BBCIC is a collaboration of managed care organizations, integrated delivery systems, pharmacy benefit management firms, research institutions and pharmaceutical companies. The BBCIC is the only research network dedicated to post-marketing assessment of biosimilars.
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