How will biosimilar Benepali approval impact European rheumatology market?

Following the recent European Commission approval of the Benepali, a biosimilar of Enbrel (etanercept) from Samsung Bioepis (The Pharma Letter January 18), Anees Malik, principal analyst at global healthcare research firm Decision Resources, offers the following commentary about the approval and its impact on the European rheumatology therapy market:

“The EMA’s approval of Samsung Bioepis’ Benepali is, arguably, a more significant event for European rheumatologists and European payers than the approval of biosimilar infliximab in 2013. The uptake of biosimilar infliximab has been muted based on rheumatologists relatively late-line use of the reference brand, Remicade. In contrast, Benepali’s reference brand, Enbrel, is a favored early-line biologic therapy where physician decisions are relatively uncomplicated by patients’ disease severity and stability, as well as patients’ history with biologics. We believe this will result in rheumatologists being more open to using Benepali, particularly in biologic-naïve patients.”

“Based on these factors and the considerable cost-burden branded TNF-alpha inhibitors represent, European payers expect to aggressively push use of lower-cost biosimilar etanercept, which will also help uptake. These market factors do mean we expect some cross-brand erosion, particularly of Humira [adalimumab, from AbbVie] the other dominant early-line biologic in the rheumatic space, until adalimumab biosimilars launch.”