News | October 3, 2022

FDA Awards $1.3M Grant To Biologics & Biosimilars Collective Intelligence Consortium

Alexandria, VA /PRNewswire/ - The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) announced today that it 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—entitled "Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence"—reflects BBCIC's longstanding commitment to evaluating the safety and effectiveness of biologics, including biosimilars, through the generation of reliable, real- world data (RWD) and 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 (medical claims and electronic health records, e.g.). 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 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. To date the following organizations have made financial and in-kind commitments: AbbVie, Aetna/CVS Health Clinical Trial Services, Amgen, Anthem/Healthcore, Apobiologix, Arthritis Foundation, Boehringer Ingelheim Pharmaceuticals, Inc, Express Scripts, Inc., Group Health Cooperative/Kaiser Permanente of

Washington Research Institute, Harvard Pilgrim Health Care, HealthPartners, Henry Ford Health System, Hematology Oncology Pharmacy Association, IQVIA, Momenta Pharmaceuticals, Inc., Merck, Optum, Patient Advocate Foundation, Pfizer, and Sandoz.

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About AMCP
AMCP is the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP's diverse membership of pharmacists, physicians, nurses, biopharmaceutical professionals, and other stakeholders leverage their specialized expertise in clinical evidence and economics to optimize medication benefit design and population health management and help patients access cost-effective and safe medications and other drug therapies. AMCP members improve the lives of nearly 300 million Americans served by private and public health plans, pharmacy benefit management firms, and emerging care models.

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Source: AMCP

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