Generic antibiotics are more important than ever, but supply shortages threaten their usefulness


On May 15, members of multiple European infectious disease societies highlighted the need to preserve existing generic antibiotics to treat bacterial infections. Antibiotics currently recommended in guidelines are facing increasing pressures of existence. In particular, generic antibiotics, such as penicillins, nitrofurantoin, fosfomycin, or pivmecillinam struggle to be commercially viable in an environment that promotes the discovery of novel broad-spectrum antibiotics with activity against multidrug-resistant (MDR) bacteria.

While in many other disease indications, R&D efforts have excelled in improving available medication by introducing more efficacious and safer drugs to the market, antibiotic drug development efforts have largely struggled to keep pace.

This dearth of antibiotic development, together with the emerging threat of antibiotic resistance, has led to the increased importance that older, generic antibiotics have in the treatment of bacterial infections. GlobalData notes that in an era of documented antibiotic resistance to almost all approved treatment options, antibiotics should be utilised wisely. Novel antibiotics should be reserved for the treatment of MDR pathogens, while older, generic antibiotics continue to play an essential role as first-line therapy for infections that continue to be susceptible to these drugs.

Prof. Pulcini and colleagues identified high registration costs and a limiting market size of old antibiotics as major barriers for their availability in many countries. GlobalData believes that the same arguments hold true for new antibiotic entrants in the market, as these drugs are preliminarily reserved for MDR pathogens and won’t return profits for the developing companies in the interim period. It is estimated that a third of effective generic antibiotics, many of these listed on the World Health Organization (WHO)’s Essential Medicine List, are no longer marketed in over 20 countries. Furthermore in the US, a staggering 148 antibiotics experienced shortages on multiple occasions between 2001 and 2013.

In the current hostile environment for these antibiotics, researchers call upon the WHO and the European Commission to extend their list of essential medicines to include these antibiotics in order to allow for universal access. Furthermore, in an effort to avoid an upsurge in prices for these medicines, like that already experienced in the US market, Prof. Pulcini and colleagues urge future commercialisation of these antibiotics to be regulated by a global antibiotic access and conservation fund, an oversight committee guaranteeing access and funding of these key antibiotics. 

For more strategic insight into drug development trends, take a look at GlobalData's latest reports.