European Biologic Manufacturers Issue Warnings About Biosimilar Switching Save

Reuters has reported that European drugmakers have taken the tact of warning EU physician contemplating the switch from existing (originator) biologic therapy to newer, cut-rate biosimilar.  Biosimilar use is widespread outside the USA.

The European Medicines Agency (EMA) has to date approved two dozen biosimilars compared to only 4 in the USA. For instance, just last month, Celltrion launched Truxima, its new biosimilar version of Rituximab (Rituxan or MabThera) Truxima has been approved in all of Rituxan/MabThera's indications.

Reuters reports that 3 industry associations representing branded drug firms issued a joint statement that doctors should look at the circumstances of each individual patient before switching them from established drugs to cheaper biosimilars.

The issue of interchangeability has yet to play out in and outside of the USA. First companies have to show studies proving the safety and efficacy of changing out to a biosimilar.  This hurdle was first met by the recently presented NOR-Swich Study.  In the EU, most biosimilar use has been mandatory and concerns were mitigated by steep (~50-70%) discounts.  In the US, the discounts thus far are embarassingly low, with Inflectra price at 15% less than Remicade.

This report may reflect the defensive posturing of biologic manufacturers who stand to loose a great deal should biosimilar use become mandatory or financially prudent.  

Manufacturers can either play the price game or create a safety concern to stall the update of biosimilars. It remains to be seen if either approach will benefit patients or confuse prescribers.