Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Scientific guideline

This document assists in the generation of relevant quality, non-clinical and clinical data to support a marketing authorisation of intravenous liposomal products developed with reference to an innovator liposomal product.

Keywords: Intravenous liposomes, comparability, pharmaceutical quality, pharmacokinetics, non-clinical, clinical studies, liposomal products, generics

Current effective version

Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2

AdoptedReference Number: EMA/CHMP/806058/2009/Rev. 2Summary:

Development of drug delivery systems to improve disease-specific targeting, to control drug release rates and/or to produce a pharmaceutical formulation suitable for clinical use is desirable.

Document history - Revision 2 (current version)

Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2

AdoptedReference Number: EMA/CHMP/806058/2009/Rev. 2Summary:

Development of drug delivery systems to improve disease-specific targeting, to control drug release rates and/or to produce a pharmaceutical formulation suitable for clinical use is desirable.

Overview of comments received on reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

Reference Number: EMA/682105/2012

Draft reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

Draft: consultation closedConsultation dates: 21/07/2011 to 31/01/2012Reference Number: EMA/CHMP/806058/2009Summary:

There has been a significant interest to develop drug delivery methods for potent albeit sometimes toxic, highly lipophilic/poorly water soluble, unstable compounds, or for tissue targeting of highly water soluble compounds. One of the strategies has been encapsulation of the active substance(s) in the aqueous phase of a liposome, or incorporation or binding to the lipid components. Liposomes are classically described as vesicles composed of one or more concentric lipidic bi-layers.