Biochemical Engineering Special Interest Group
biological engineering professionals
29 December 2016

FDA Completes Guidance on Developing Biosimilars

Drugmakers received guidance from the FDA Dec. 28 on developing cheaper imitations of certain biologic drugs, known as biosimilars. The guidance will help drugmakers 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 Food and Drug Administration said. 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. Source: Bloomberg 29/12/2016

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