SB4 (Benepali®; an etanercept biosimilar): a profile of its use

Compliance with ethical standards

Funding: The preparation of this review was not supported by any external funding.

Conflicts of interest: K. McKeage and K.A. Lyseng-Williamson are employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.

Additional information about this Adis Drug Review can be found here.

Abstract

SB4 [Benepali® (EU); Brenzys™ (Australia, Canada, Korea)] is an etanercept biosimilar approved for all indications for which reference etanercept is approved, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. In a phase 3 trial in patients with moderate to severe rheumatoid arthritis receiving methotrexate, the efficacy of subcutaneous SB4 was equivalent to that of reference etanercept, and both agents had a similar tolerability profile, except for a higher incidence of injection-site reactions with reference etanercept. In patients switched from reference etanercept to SB4, there was no loss of efficacy or an increase in adverse events or immunogenicity. Switching to treatment with SB4, using a well-designed communication strategy, may potentially result in cost savings for healthcare budgets, thereby improving patient access to treatment. Access to the full article can be found here.

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