EMA: Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

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.