In december 2016 the FDA issued guidance to assist applicants seeking FDA approval of a proposed biosimilar product under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The guidance will help develop a clinical pharmacology program to support a decision that a proposed biosimilar isn’t meaningfully different clinically from a branded or reference product.
The document is meant to assist drugmakers with proving they have created a new drug that can be used in the same way as an existing one.
