"And frankly, we would have to be asking ourselves what kind of stupid pills management have been taking that prevented them from going down this path 10 years ago."
The generic drug market in the US has grown 13% CAGR between 2011-2017. According to one research report, generic drugs have gone from representing <20% of prescriptions to now representing the majority.
Historically though, there's been relatively fewer generic topical products. This has been due to the added difficulty in conducing bioequivalency studies. Even if a topical treatment has the same qualitative and quantitive features, it may differ in its physiochemical (look and feel) attributes.
For topical dermatological treatments, proving bioequivalence also relied heavily on clinical trials which are expensive and long in duration.
The FDA however has recognised this barrier and the need for patients to access affordable topical treatments. As such, they've recently moved to ease the regulatory pathway for new generic topical product approvals.
This is combined with the scientific advances in determining bioequivalency. Have a look into some of the following surrogate approaches: dermatopharmacokinetic study (DPK), dermal microdialysis (DMD), in vitro studies, pharmacokinetic study (PK), near-infrared spectrometry (NIR), and confocal Raman spectroscopy (CRS). The use of biowaivers for topical dermatological products has also been explored by pharmaceutical scientists.
So in answer to your question, the strategy for Acrux to go down this path only recently may have been due to a combination of:
a) Recent FDA loosening of regulatory pathways for getting generic topical products to market.
b) Recent advances in technology to ascertain bioequivalence without the need for expensive and timely clinical trials.
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