Generic Drug Equivalence

Viva la “sameness” – Ensuring Generic Drug Equivalence

Generic drugs make up about 80% of drugs used by US consumers and the percentage of generic drugs used elsewhere around the world is rapidly growing as healthcare costs rise and generic drugs look more and more attractive.  But the challenge for generic drug developers has always been ensuring equivalence to the innovator’s original drug.

Recent reports suggest that there is a $20 million quality evaluation and testing program, involving a dozen academic centers, which is being overseen by the FDA.  This program is designed to address fears as to the quality of generic drug products, and is part of a drive for closer links between regulators and generic manufacturers.

Although there might be a dozen ingredients in a tablet, a nasal spray, or topical formulation, for example, it is well understood that the active pharmaceutical ingredient, or API, is the main ingredient of interest. One of the critical quality attributes in ensuring “sameness of the brand”, as described by Tony Mauro, North American President of Mylan, is the particle morphology of the API.

In their efforts to help understand generic drug performance, the FDA has invested in a new technology that helps accelerate the bio-equivalence characterization process by automatically comparing API particle morphology and particle size distributions within innovator and generic finished drug formulations.  The FDA’s Bill Doub , in a recent interview,  talked about the acquisition of the Morphologi G3-ID from Malvern Instruments.

The G3-ID can help “de-formulate” nasal sprays, topical formulations and oral solid dose formulations by automatically measuring critical morphological attributes of API and other components within the formulation.

We will address a number of these applications with a series of blogs over the next few weeks.  To start us off here is a link to an application note describing how the Morphologi G3-ID can help reverse engineer a powder blend. Look out for the next in the series which will look at topical (cream) formulations.