Technical considerations in demonstrating interchangeability of the biosimilar with the reference product
HU Xiao-min
ZONG Ying
GAO Chen-yan
WANG Hai-xue
XIA Yu-ye
ZHU Jiang-bo
YUAN Bo-jun
LU Guo-cai
WANG Qing-li
Abstract：Biosimilar is a therapeutic biological product with similarity in quality,safety and efficacy to the reference product.To determine whether the biological product is interchangeable with the reference product,FDA requires further evidence to show that the biological product is biosimilar to the reference product.Namely it can be expected to produce the same clinical result as the reference product in any given patient.The risk in terms of safety,or diminished efficacy of alternating or switching between use of the biological product and the reference product,is not greater than the risk of using the reference product without such alternation or switch.The draft guidance "Considerations in demonstrating interchangeability with a reference product" released by the FDA in January 2017 requires the sponsor to provide data and information needed to support a demonstration of interchangeability.The technical requirements in demonstrating interchangeability of the biosimilar with the reference product include but not limited to:study endpoints,study design and analysis,study population,condition of use to be studied,route of administration,and extrapolation of data.
Keywords：biosimilarinterchangeabilityproposed interchangeable productreference producttechnical requirement
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1767-1772 )