Merck & Co.

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Public Policy Statement | December 2023
Biosimilars

Biologics are complex proteins derived from living sources and are generally more complex
than small-molecule drugs. Due to the specific development and manufacturing process
for biological products, a biosimilar cannot be “identical” to its reference product, as is the
case for small-molecule generics. Biosimilar policies must therefore reflect the specificities
of biologics, particularly regarding switching and substitution,...