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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.
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.
© Springer International Publishing AG, part of Springer Nature 2017