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  1. FDA STEM Outreach, Education and Engagement

Development of a Biosimilar 351(k) BLA Clinical Pharmacology Study Database

Authors:
Poster Author(s)
Wong, Mitchell, FDA/CDER (Student); Wang, Yow-Ming, FDA/CDER (Mentor)
Center:
Contributing Office
Center for Drug Evaluation and Research

Abstract

Poster Abstract

Background

Biosimilars, are licensed through the 351(k) BLA pathway, are becoming an ever increasingly important part of the American medication market today. As novel biologic patents expire, it is expected that the number of 351(k) BLAs will increase tremendously. This unique situation requires that OCP be prepared in advance to know what to expect of clinical pharmacology studies in 351(k) BLAs. Even though FDA has published guidances that laid out general principles on how to use clinical pharmacology data to support biosimilarity, the implementation of clinical pharmacology programs for biosimilar development tends to vary from product to product due to the diverse PK profiles of biosimilars.

Objective

This project aims to establish a database for the clinical pharmacology studies in 351(k) BLAs which will explore the similarities or differences in study design, enhance special considerations across products, and facilitate evaluation of potential areas with opportunities to improve efficiency in biosimilar programs. Such analysis will give OCP the chance to streamline the 351(k) approval process and allow the clinical pharmacology review of biosimilars to progress in a more timely and efficient manner.

Methods

This Biosimilar 351(k) Clinical Pharmacology Study Database will consolidate all of the clinical pharmacology studies (PK, PD, CCS, and Safety) from the 351(k) BLAs that have been filed with CDER to date (7/30/21). A total of 30 approved biosimilar BLAs were identified using DARRTS. Study reports in DocuBridge and FDA reviews are reviewed and study information is parsed and brought into the database. The goal is to include study design information as well as study results information in the database which is being built using Microsoft Excel.

Results

As of 7/30/21, the FDA has approved 30 351(k) biosimilar BLAs. Based on the work completed so far, the database contains 5 worksheets: (1) the master list of all the 351(k) BLAs, (2) PK similarity studies, (3) PD similarity studies, (4) Comparative Clinical Studies (CCS), and (5) Safety studies. Sheets 2-5 have the following parameters: Study number, Study design, Products compared, Study population, Sample size, Dose, and Route of administration. In addition to these common parameters, each sheet has unique parameters specific to the study type. Sheet 2 (PK similarity studies) has PK endpoints, PK Sampling Times, and the statistical method used to evaluate similarity. Sheet 3 (PD similarity studies) has PD biomarker, PD Endpoints, PD Sampling Times, and the statistical method used to evaluate similarity. Sheet 4 (CCS) has study endpoints, clinical primary endpoint time, study duration, and statistical method used to evaluate similarity. Sheet 5 (Safety studies) has Safety/Immunogenicity Endpoints, Immunogenicity Sampling Times, and statistical methods.

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