Biosimilar Cell Line Biosimilar Cell Line | Page 2

Biosimilar Cell Line
A biosimilar is a biological medical product that is claimed to be highly similar to an already approved
original biological product (known as a reference product). With expiry of patents on many top
revenue biological medicines, there is an increasing interest in biosimilars for biopharmaceutical
manufacturers.
The development process of biosimilars involves: 1) selection of a reference product that is off patent
(hormone/cytokine/antibody); 2) in-depth analysis of the reference product to obtain the critical
quality attributes (CQAs); 3) development of a manufacturing process to match the CQAs of the
reference product involving cell line establishment and optimization, protein purification, rigorous
similarity evaluations between the reference product and the biosimilar etc.