FDA Biosimilars Draft Guidance - Quality Considerations in Demonstrating Biosimilarity to Reference Product

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  • Date: March 23, 2012

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

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