colorful map of Europe

On January 16th 2016, Samsung Bioepis announced that it had succeeded in gaining EMA approval for Benepali (biosimilar etanercept). The product, which underwent clinical development in healthy volunteers and rheumatoid arthritis patients, was approved for all the adult indications for which Enbrel is approved, namely rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and plaque psoriasis. However, unlike Enbrel, Benepali is not approved for juvenile idiopathic arthritis or pediatric plaque psoriasis. This is due to Benepali only being available in presentations (single-use pre-filled syringe and pre-filled pen) that contain 50mg etanercept per dose.

Benepali’s approval is a remarkable achievement for the joint venture established between Samsung and Biogen just over 4 years ago. The product will be marketed by Biogen in Europe.

The EMA’s approval of Samsung Bioepis’s Benepali is, arguably, a more significant event for European rheumatologists and European payers than the approval of biosimilar infliximab in 2013. It is fair to say that the uptake of biosimilar infliximab has been muted amongst rheumatologists based on the relatively late-line use of the reference brand, Remicade. In contrast, Benepali’s reference brand, Enbrel, is favored in early lines of biologic therapy where physician decisions are relatively uncomplicated by the patient’s disease severity and stability, as well as the patient’s history with biologics. We believe this will result in rheumatologists being more open to using Benepali, particularly in biologic-naïve patients. Furthermore, based on these factors and the considerable cost-burden branded TNF-alpha inhibitors represent, our research shows that European payers expect to push use of lower-cost biosimilar etanercept aggressively, which will also help uptake. These market factors do mean we expect some cross-brand erosion, particularly of Humira, the other dominant early-line biologic in the rheumatic space, until adalimumab biosimilars launch.

However, Benepali will be less attractive to European dermatologists than rheumatologists, since the drug’s approval in psoriasis was based on indication extrapolation. Benepali is unlikely to capture a portion of Enbrel’s sales generated in juvenile idiopathic arthritis and pediatric psoriasis because it was not approved by the EMA for those indications.

From a competitor perspective, we expect Benepali to benefit from being the only etanercept biosimilar on the European market until the launch of Sandoz’s GP2015, which we forecast to occur in Q2 2017. Based on Benepali and GP2017 being tested in differing patient populations, RA and psoriasis, respectively, each product might end up the preferred etanercept biosimilar amongst different specialty groups, at least until a third etanercept biosimilar launches. Furthermore, with Biogen marketing Benepali in Europe a lot of concerns and trust issues physicians might have had with Benepali being developed by Samsung Bioepis, a new entrant into the biopharmaceutical market, are likely to be reduced.

Subscribers to DRG’s Biosimilars Advisory Service may access further analysis of this event. Please contact for further information.

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