Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product

Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product is the final version of a draft guidance for industry originally released in 2012. It describes the Agency’s current thinking about factors to consider when demonstrating that a proposed therapeutic protein product is highly similar to a reference product, with recommendations focused on scientific and technical information related to chemistry, manufacturing, and controls (CMC). In particular, this document provides guidance on analytical studies relevant to assessing whether the proposed product and a reference product are highly similar.

The full document is available on the FDA website.