Biologics and Biosimilars Intelligence Consortium Awarded $1.3 Million

On October 3, 2022, the FDA awarded the Biologics and Biosimilars Collective Intelligence (BBIC) a $1.3 million grant to be paid out in the next two years. The grant is intended to fund a study on developing biosimilars and improving their efficacy.

According to the press release, the study is called "Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence." The purpose is to ensure safe, effective, and reliable biosimilars using real-world data and evidence.

The press release states, “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.”

This grant and the conduction of this study — if successful — will allow for improved availability of biosimilars and will improve their uptake. A survey conducted by Vizient earlier this year stated that biosimilars have saved the United States approximately $12.6 billion between 2014 and 2022.

Since biosimilars do not require extensive clinical trials, their production is significantly cheaper. Additionally, another available medication can increase competition, reducing costs for patients and payers.

Despite the potential benefits of biosimilars, there are some limitations in the creation, development, testing, and implementation of these medications.

"The challenge 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, in the press release. "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."

As the cost of prescription drugs continues to rise, the potential for reduced medication costs provides significant hope for patients, payers, and providers. While biosimilars will continue to undergo vigorous regulation protocols by the FDA and other organizations, extensive research on the development and efficacy of these molecules may streamline the process.