Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

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

Award Number: U01FD007757
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 02/28/2025

Group Awards By:

View Award Description

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	ACADEMY OF MANAGED CARE PHARMACY	675 N WASHINGTON ST	ALEXANDRIA	VA	22314	ALEXANDRIA CITY	USA	Food and Drug Administration Research	000	1	3/24/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	ACADEMY OF MANAGED CARE PHARMACY	675 N WASHINGTON ST	ALEXANDRIA	VA	22314	ALEXANDRIA CITY	USA	Food and Drug Administration Research	000	1	7/16/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,311,368 )
2022	2022	ACADEMY OF MANAGED CARE PHARMACY	675 N WASHINGTON ST	ALEXANDRIA	VA	22314	ALEXANDRIA CITY	USA	Food and Drug Administration Research	000	1	8/24/2022	NEW	$1,311,368
														Subtotal = $1,311,368

Grand Total All Awards = $1,311,368

Top

All Categories

About

Search

Reports

Data Submission

Award Information

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

Award Number: U01FD007757

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 02/28/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer