FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

FDA’s initial draft guidances for development of biosimilars specify that a sponsor will have to submit at least one clinical study comparing the immunogenicity of its proposed product with that of the reference biologic. A clinical study will also be required for a biosimilar to be considered interchangeable with the reference product.

The agency issued three guidance documents on Feb. 9 to assist the industry in developing products under the biosimilars abbreviated approval pathway