# Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data

> **NIH FDA U01** · ACADEMY OF MANAGED CARE PHARMACY, INC. · 2022 · $1,311,368

## Abstract

Project Summary
The digital sharing and storage of healthcare information—medical claims and
electronic health records—has produced lakes of real-world data (RWD) in the modern
health care landscape. This volume of digital data, along with revolutions in big-data
analysis, provide a new opportunity to use RWD to produce real-world evidence (RWE).
RWD/RWE can improve the regulatory science around the development and review of
biosimilar drugs.
RWD have the potential to capture information from tens of millions of patients in real-
world clinical practice. The use of RWD/RWE to improve the efficiency of clinical trials
for biosimilar products will speed the development of new biosimilars, the process of
granting the regulatory designation of interchangeability, and encourage more rapid
uptake of the products in the market.
The lack of evidence on the quality of RWD and on the relevance of RWE for regulatory
decision-making about biosimilars is a major obstacle to using big-data analyses of
RWD/RWE for these decisions. The study, “Improving the Efficiency of Regulatory
Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World
Data to Produce Real-World Evidence,” will provide the research community with
analytical tools they can re-use for their own tests of interchangeability and other
regulatory questions. In the proposed study, we will:
Aim 1: Determine the quality of RWD and the relevance of RWE for regulatory decision-
making. We will conduct a literature review and convene an expert panel to establish
the data needs for regulatory approvals of new biosimilars and designations of
interchangeability. Then we will determine whether and where RWD/RWE could
reasonably be used to address regulatory data needs.
Aim 2: Use RWD/RWE to emulate an FDA evaluation of interchangeability of a
biosimilar drug. We will design and conduct a target trial emulation of a switching study
and compare outcomes produced from the emulation to those obtained from the FDA’s
evaluations of interchangeability of the reference drug.

## Key facts

- **NIH application ID:** 10618571
- **Project number:** 1U01FD007757-01
- **Recipient organization:** ACADEMY OF MANAGED CARE PHARMACY, INC.
- **Principal Investigator:** Catherine Marie Lockhart
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $1,311,368
- **Award type:** 1
- **Project period:** 2022-09-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10618571

## Citation

> US National Institutes of Health, RePORTER application 10618571, Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data (1U01FD007757-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10618571. Licensed CC0.

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