BIOSIMILAR DEVELOPMENT AND MANUFACTURING
Sourcing reference products
A biosimilar is a copy version of an approved, original biological medicine whose patent protection has expired. The development strategies for biosimilar product and a new biological entity (NBE) differ in many ways.**
Author: Andreas Nechansky, Site Manager, ABF Pharmaceutical Services (Member of GBA Group Pharma)
For biosimilar products, the mode of action is the same as than of the marketed product, thus minimizing the risk of failing in clinical trials. However, the regulatory expectations regarding the product quality and the biosimilarity assessment prior to entering into the clinical stage makes the development of a biosimilar product more difficult (and more expensive in the preclinical phase) compared to an NBE. Strict guidelines from the EMA and the FDA have been published that raise the bar very high for companies that develop biosimilars. Because most process information for the innovator is not available to the public, establishing biosimilarity to innovator (also called the reference product) is challenging.