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Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370.

Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects.

Author information

1
a Christchurch Clinical Studies Trust , Christchurch , New Zealand.
2
b Boehringer Ingelheim , Ingelheim , Germany.
3
c SGS, Clinical Pharmacology Unit , Antwerp , Belgium.
4
d Auckland Clinical Studies Limited , Auckland , New Zealand.

Abstract

BACKGROUND:

This Phase I study (VOLTAIRE®-PK) aimed to evaluate three-way pharmacokinetic similarity (bioequivalence), safety, and immunogenicity of BI 695501 (a Humira® [adalimumab] biosimilar candidate) compared with US- and EU-approved Humira in healthy male subjects.

METHODS:

Subjects (N = 327) were randomized 1:1:1 to receive one 40-mg subcutaneous dose of BI 695501, US- or EU-approved Humira; safety was assessed for 70 days. Bioequivalence was evaluated using the average bioequivalence method to test if the 90% confidence intervals (CIs) of the geometric means (BI 695501 vs US- and EU-approved Humira) for the primary end points were within prespecified acceptance ranges (80-125%). Immunogenicity was assessed using a sensitive bridging method.

RESULTS:

Bioequivalence between BI 695501 and US- and EU-approved Humira was demonstrated with the 90% CIs of the ratios of all primary end points: Cmax, AUC0-inf, pred and AUC0-tz being within the prespecified acceptance ranges of 80-125%. Concentration vs time profiles were similar as were the time course and frequency of immunogenic responses. All study drugs showed similar safety and tolerability results.

CONCLUSIONS:

Three-way bioequivalence of BI 695501 to US- and EU-approved Humira was demonstrated; safety and immunogenicity results of the three study drugs were also similar.

CLINICAL TRIAL REGISTRATION:

2013-003722-84 (EudraCT) and NCT02045979.

KEYWORDS:

Adalimumab; BI 695501; Humira; bioequivalence; biosimilar; pharmacokinetics

PMID:
27813422
DOI:
10.1080/13543784.2016.1255724
[Indexed for MEDLINE]

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