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.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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