FDA Awards $1.3M to Biologics & Biosimilars Consortium

The Food & Drug Administration (FDA) has awarded The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) $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”—will evaluate 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.”
 
The 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.