The Evolving Biosimilar Landscape: Approval of the First Etanercept Biosimilar in Europe


An Interview With Emilio Martín-Mola

Received: 17.03.16 Accepted: 19.07.16
Citation: EMJ. 2016;1[3]:76-84.


On January 14th 2016, SB4 (Benepali®) received marketing authorisation application approval from the European Commission (EC). It is the first biosimilar to etanercept available in Europe as well as the first subcutaneous anti-tumour necrosis factor biosimilar. Benepali® was approved for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic spondyloarthritis), and plaque psoriasis.

SB4 adds to the available biologic armamentarium of biosimilars in rheumatology, which also includes two infliximab biosimilars; one under the brand names Remsima® and Inflectra®, and the other under the brand name Flixabi®. Unlike infliximab biosimilar, which is a chimeric monoclonal antibody, SB4 is a fusion protein.

We aimed to review the current European Medicines Agency (EMA) requirements for the approval of biosimilars and how these products can integrate into daily clinical practice in rheumatology.

To that effect, we recently discussed with Dr Emilio Martín-Mola about the European framework for approval of biosimilars and the controversies that may surround this new category of medicinal products. We discussed how the advent of biosimilars in rheumatology has the potential to truly be a game-changer for both physicians and patients


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