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New data on biosimilars of the big three anti-TNF drugs presented at EULAR 2016

Published on 08/06/16 at 03:35pm

Samsung Bioepis has presented data at EULAR 2016 on three biosimilars of the highly selling anti-TNF drugs Remicade (infliximab), Enbrel (etanercept) and Humira (adalimumab) showing comparable efficacy and safety profiles of the reference product.

Developed by Samsung Bioepis, their biosimilars Benepali (etanercept) and Flixabi (infliximab) have already received approval in the EU.

Their biosimilar of Humira, called SB5, has yet to reach regulatory approval stage, but Samsung Bioepis has presented Phase III data on SB5 at EULAR 2016 in London. In a 52 week Phase III study, patients received either SB5 for the full duration, Humira for the full duration, or were switched to SB5 from Humira half way through. Broadly similar efficacy and safety profiles were observed across the three groups of patients.

Samsung Bioepis also presented further data on the sustained comparable efficacy and safety profiles after switching from reference product to biosimilar version in Benepali and Flixabi.

Christopher Hansung Ko, CEO of the company, comments: “Payers and healthcare providers must be given sufficient clinical evidence, so that they can make informed decisions when deciding whether to switch to a biosimilar treatment option. Our clinical studies have demonstrated that transitioning from a reference product to its biosimilar version yields comparable outcomes with regards to both the efficacy and safety of treatment.”

Although approved in the EU, many member states differ on their approach to biosimilars. While physicians in some countries will not switch from originator to biosimilar – reserving the biosimilar version for new patients receiving treatment – this data suggests no meaningful clinical downside in switching to the biosimilar.

Samsung Bioepis has already taken Humira makers AbbVie to court, for blocking the launch of its biosimilar version of the arthritis medication.

This data was presented at the 2016 EULAR conference taking place in London 8-11th June.

Sean Murray

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