Posted by Michael Wonder on 30 Dec 2016
FDA completes guidance on the development of biosimilars
29 December 2016 - Drug makers received guidance from the FDA on 28 December on the development of biosimilar medicines.
The guidance will help drug makers 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 FDA said. The document is meant to assist drug makers with proving they have created a new drug that can be used in the same way as an existing one.
