Phase 3 Studies Show Efficacy of Sandoz Biosimilars Adalimumab, Etanercept

Biosimilars adalimumab and etanercept showed equivalent safety and efficacy to reference products in patients with rheumatoid arthritis.

New data from 2 phase 3 studies showed favorable results for Sandoz’s proposed biosimilars adalimumab and etanercept (Erelzi) in patients with moderate-to-severe rheumatoid arthritis (RA).

Adalimumab is an inhibitor of the tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions. Adalimumab works by targeting and blocking the protein that contributes to disease symptoms, making it a potentially appropriate treatment option across a variety of indications, according to Sandoz.

In the ADMYRA trial, biosimilar adalimumab matched the reference biologic in terms of safety, efficacy, and immunogenicity in patients with moderate-to-severe RA at 24 weeks. The trial compared the efficacy and safety of the proposed biosimilar with its reference product in patients with an inadequate response to disease-modifying anti-rheumatic drugs, including methotrexate, up to week 48.

For the study, 353 patients received either 40 mg subcutaneous proposed biosimilar adalimumab or reference adalimumab biweekly up to week 22. According to the data, mean change from baseline at week 12 in Disease Activity Score, including high-sensitivity C-reactive protein (DAS28-CRP), was -2.16 for proposed biosimilar adalimumab (n=140) and -2.18 for reference adalimumab (n=144), meeting the study’s primary endpoint.

Treatment emergent adverse events (TEAs) in the trial were mostly mild or moderate, with the most commonly reported TEAs being infections and infestations.

Etanercept, also a TNF inhibitor, is currently approved for the treatment of RA, juvenile RA, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.

Data from the phase 3 EQUIRA study showed that biosimilar etanercept did not affect efficacy and safety in patients with moderate-to-severe RA. This 48-week study evaluated the efficacy and safety of biosimilar etanercept and reference etanercept (Enbrel), as well as the effects of switching to biosimilar etanercept in patients with moderate-to-severe RA.

Adult patients with active RA received either 50-mg biosimilar etanercept or reference etanercept, subcutaneously and once weekly, for 24 weeks. The study met the primary endpoint of equivalent change from baseline in DAS28-CRP at week 24. At week 24, patients with at least moderate EULAR response either continued treatment or switched to receive the biosimilar etanercept for up to 48 weeks.

According to the findings, ACR 20 response rates were comparable between patients who continued on or switched to biosimilar etanercept at week 48.


Sandoz delivers positive results for proposed biosimilars adalimumab and etanercept [news release]. Sandoz’s website. Accessed October 23, 2018.

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