FDA - Labelling for Biosimilar Products

The principal components of therapeutic biological products are large, complex molecules like monoclonal antibodies and cell signaling proteins. The nature of biological products creates unique challenges that generally do not exist with small molecule drugs. For instance, unlike small molecule drugs made through chemical synthesis, biological products are produced in living systems, such as microorganisms, plant cells or animal cells.

In relation to these products, the U.S. FDA has issued new guidance on how they should be marketed and labelled.

A draft guidance for industry has been produced, which can be accessed here. 



Posted by Dr. Tim Sandle