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- 01/11/2017

FDA guidance to assist applicants seeking FDA approval of a proposed biosimilar product

Pharma Horizon

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.

 

Read the guidance




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