Bioequivalence and Bioavailability Forum

❝ One of our sponsor wants to conduct Bioequivalence study for an Emulsion formulation for intravenous route. Sponsor plans to market the drug as generic version of Innovator in South Africa. But, he enquired whether we can go for biowaiver instead of BE study for Emulsion formulation.

Dear Mr Suraj,

Biowaiver is acceptable for Emulsion provided if fulfills the following requirements as per MCC's Biostudies Guidance.

Quote from Guidance

Emulsions normally do not qualify for a biowaiver.
However, emulsion formulations may be considered eligible for a biowaiver where:

(a) the product is not designed to control release or disposition
(b) the method and rate of administration is the same as the currently approved product

In these cases, the composition should be qualitatively and quantitatively the same as the currently approved emulsion as stated above, and satisfactory data should be provided to demonstrate very similar physicochemical characteristics, including size distribution of the dispersed lipid phase, and supported by other emulsion characteristics considered relevant e.g. surface properties, such as Zeta potential and rheological properties.

Unquote

Reference: https://www.sahpra.org.za/wp-content/uploads/2020/01/61de452d2.06_Biostudies_Jun15_v6.pdf