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FDA Funds Study of Real World Data for Biosimilars

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10 Oct. 2023. A group of managed care organizations is examining the value of real world data from Europe and the U.S. to help FDA review alternative biologic drugs. The Food and Drug Administration is giving the Biologics and Biosimilars Collective Intelligence Consortium or BBCIC a grant of $1.4 million to assess if real world data from outside the U.S. can play a role in reviewing new so-called biosimilar therapies.

Biosimilars are biologic therapies derived from live cells or microorganisms, such as yeast or bacteria, for treating some chronic and immune-related diseases, which are given to patients and work in the body the same way as the original branded biologics. Unlike generic drugs made as copies of the original brand-name medications, biosimilars may have minor variations from the original biologic chemistry, but they need to show the same purity, potency, and safety of the original product. And like generics, biosimilars are offered as less expensive treatment options as original branded biologics.

BBCIC in Alexandria, Virginia is a not-for-profit organization that evaluates real world safety and effectiveness of biologic drugs, including biosimilars. The group was formed by the Academy of Managed Care Pharmacy in 2015 and includes managed care organizations, research institutes, pharmaceutical companies, and pharmacy benefit managers that administer prescription drug programs and negotiate discounts for health insurance plans. BBCIC conducts research on use of biologics and biosimilars, including real-world experiences and outcomes from using these medications in clinical settings, after their approval by regulatory agencies.

Value of overseas data for regulatory review

The study for FDA seeks to assess the value of real world data, such as de-identified medical records and insurance claims from outside the U.S., to that agency’s regulatory review of biosimilar candidates and other actions. The study team is looking specifically at real world data from Italy and Denmark, as well as the U.S. Leading the research are Gianluca Trifirò, professor of pharmacology at University of Verona in Italy and Jesper Hallas, professor of clinical pharmacology at University of Southern Denmark in Odense.

Cate Lockhart, BBCIC’s executive director, says in an Academy of Managed Care Pharmacy statement that findings from the study can help speed FDA’s review of biosimilars, with benefits for patients. “The current approval process for biosimilar products is complex,” says Lockhart, “delaying patients’ access to cost-effective therapies. Using real world data from foreign countries will help improve the FDA’s work and ultimately help patients receive access to approved therapies in a timelier manner.” Lockhart adds that the study “aligns with the FDA’s mission to make safe and effective drugs available to patients nationwide.”

Real world data from electronic health records and insurance claim databases are becoming more valuable resources to guide medical decision-making, to supplement or follow-up on clinical trials, as well as for regulatory agencies. In April 2023, Science & Enterprise reported on a medical journal article with an analysis of insurance claims records matching the design of randomized clinical trials, which shows claims data can in some cases resemble clinical trial results to make causal inferences. The paper draws on work by the RCT-Duplicate project — RCT standards for randomized clinical trials — that receives financial support from FDA.

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