Stability Design and Analysis of Biosimilar Products

• Activity Number: 179
• Type: Contributed
• Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Annpey Pong*+ and Shein-Chung Chow
• Companies: Merck Research Laboratories and Duke University
• Keywords: Biosimilars ; Follow-on biologics ; Expiration dating period ; Drug shelf-life ; Bracketing design ; Matrixing design

Abstract

For every drug product, the United States Food and Drug Administration (FDA) requires that an expiration dating period (shelf-life) must be indicated in the immediate container label for consumer's protection. Unlike small molecule drug products, biological drug products are highly sensitive to environmental factors, which may impact the quality and effectiveness of the drug. Biosimilars can only be similar to the reference product due to variations within the manufacturing process. Because of this, rigorous stability testing is crucial in comparison of originator biological products and biosimilars. This paper presents matrix study designs and statistical analyses for the establishment of stability profiles of biological products in long term stability studies. It considers matrix designs based on 1/3 and 2/3 on sampling time designs with multiple factors such as strength, batch, and package. Statistical analyses of the matrix data may be performed as one analysis either with or without testing for pool-ability. Such methods will help reduce costs for developers of biological drug products in establishing the stability and shelf life of a drug for regulatory approval.