In this issue
Issue 104 • March 2021
For nearly 40 years, generic drug manufacturers have benefitted from a regulatory system that allows generic drugs to be approved for non-patented indications. This practise – known as skinny labelling – enables drugmakers to enter the market before the brand-name drug’s patent expires, just so long as the generic is not marketed for the same indication as the patent.
Under this system, the generics market has flourished. However, the glory days of skinny labelling may be about to come to an end thanks to an ongoing legal case between GlaxoSmithKline and Teva.
As part of the case, the US federal circuit ruled that a generic pharma company could be at risk of patent infringement based on skinny labelling as generics may still be prescribed for off-label indications – including indications still covered by patent law – if the drug has been promoted as equal to its branded counterpart. But what does this mean for the future of generics? We find out.
Elsewhere in this issue, we take a look at the legacy of the HeLa cell line and the woman behind them, Henrietta Lacks, chart the rise of antibody-drug conjugates, and examine the overlooked GI symptoms of Covid-19.
All this and more in this latest issue of Pharma Technology Magazine.
Eloise Mclennan, editor