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Humira Copy Shows Clinical Equivalence in RA

Safety and immunogenicity data for adalimumab biosimilar pass pivotal test

A biosimilar version of adalimumab (Humira, Abbvie) performed as well as the reference product on clinical outcomes in patients with moderate-to-severe rheumatoid arthritis (RA), with similar overall safety and immunogenicity.

According to MedPageToday, the phase III study, presented at the American College of Rheumatology (ACR) annual meeting, met its primary endpoint of clinical equivalency for the biosimilar, ABP 501, which was the ACR20 response (20% reduction in symptoms according to ACR criteria) at week 24.

The FDA definition of a biosimilar is a biologic product that is highly similar to the reference product notwithstanding minor differences in clinically inactive compounds, and there are no clinically meaningful differences from the reference product in terms of safety, purity, and potency. One study is required to test immunogenicity, and at least one clinical study is needed in a sensitive population to confirm safety and efficacy.

ABP 501 has the same amino acid sequence as adalimumab. It had previously demonstrated pharmacokinetic similarity, and nonclinical assessments and analytical characterization indicate that ABP 501 is highly similar to adalimumab.

The phase III study enrolled 526 patients with moderate-to-severe RA who had an inadequate response to methotrexate, randomly assigned to receive 40 mg subcutaneously of either adalimumab or ABP 501 every 2 weeks until week 22. Safety was assessed to week 26.

To be eligible for inclusion, patients had to have active RA for at least 3 months, be rheumatoid factor-positive or anti-cyclic citrullinated peptide-positive at screening, and be taking methotrexate for at least 12 consecutive weeks and be on a stable dose for at least 8 weeks. Patients could not have received adalimumab or two or more biologic therapies for RA previously.

ACR20 responses were achieved by 74.6% of the ABP 501 group and 72.4% of the adalimumab group (estimated relative risk: 1.04). The 90% confidence interval was within the prespecified margin for demonstration of clinical equivalence. ACR50 responses were also similar between ABP 501 and adalimumab (49.2% for both), as were ACR70 responses (26% versus 22.9%, respectively).

The rates of adverse events were 50% in the ABP 501 group and 54.6% in the adalimumab group; the rates of grade ≥3 adverse events were 3.4% and 6.5%, respectively, and the rates of serious adverse events were 3.8% and 5.0%.

Source: MedPageToday, November 12, 2015

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