Tuesday, 6 August 2019

Development of Therapeutic Protein Biosimilars



The U.S. FDA has issued a new guidance document: “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.”

Given that demonstrating that a proposed product is biosimilar to an FDA-licensed reference product manufactured by a different manufacturer typically will be more complex and will likely require more extensive and comprehensive data than assessing the comparability of a product before and after a manufacturing process change made by the product’s sponsor, the guidance has been produced. 

A manufacturer that modifies its own manufacturing process has extensive knowledge and information about the product and the existing process, including established controls and acceptance parameters.  By contrast, the manufacturer of a proposed biosimilar will have no direct knowledge of the manufacturing process for the reference product and will have its own manufacturing process (e.g., different cell line, raw materials, equipment, processes, process controls, acceptance criteria).


Therefore, comprehensive comparative analytical data are necessary to build the foundation for a development program for a proposed biosimilar product intended for submission under section 128 351(k) of the PHS Act.

For details, see: https://www.fda.gov/media/125484/download

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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