Biosimilar Adalimumab, Hulio, Is Safe Long-Term, Causes Less Injection-Site Pain Than Humira

Mylan’s adalimumab biosimilar, developed by Fujifilm Kyowa Kirin Biologics and recently approved and launched in the European Union, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use on the basis of data including those from a phase 3 clinical trial comparing the biosimilar to its reference (Humira) in patients with rheumatoid arthritis (RA).

During this week’s European League Against Rheumatism Annual European Congress of Rheumatology, researchers will present on the long-term safety, immunogenicity, and efficacy of the biosimilar versus the reference in an open-label extension study that involved switching between the biosimilar and the reference.¹

In the open-label extension, 645 patients with RA who completed the phase 3 clinical trial with clinical response and without serious adverse events (AEs) received the biosimilar through week 76. Pooled data were analyzed up to 2 years.

In total, 216 patients received the biosimilar only for 3 treatment periods; 108 received the biosimilar, switched to the reference, then switched to the biosimilar; 108 started with the reference, then received the biosimilar for 2 treatment periods; and 213 received the reference for 2 treatment periods before switching to the biosimilar.

Across the 4 groups described above, the percentages of patients who achieved response were as follows:

• American College of Rheumatology (ACR) criteria for 20% improvement: 83.2%, 83.7%, 85.9%, and 83.6%
• ACR criteria for 50% improvement: 60.5%, 58.2%, 54.3%, and 59.8%

In total, the following percentages of patients tested positive for anti-drug antibodies (ADA) across the 4 groups, respectively: 51.9%, 61.0%, 45.2%, and 51.6%. The majority of patients with positive ADA status had neutralizing activity.

According to the authors, the safety, immunogenicity, and efficacy of the biosimilar were maintained over long-term treatment and after switching.

Separately, a research team also reported on injection-site pain linked with the administration of the biosimilar versus the reference, saying that the biosimilar had a clear advantage over the brand-name Humira in terms of pain related to administration.²

The researchers pooled data from 4 studies on the biosimilar—which has different excipients from the reference—in patients with RA and in healthy volunteers. Data were analyzed from a total of 2007 assessments in 1001 individuals.

A linear mixed model of the visual analog scale showed a 12.6-point lower pain score for the biosimilar than for the reference (95% CI, —14.3 to –10.8; P <.001). For the autoinjector and prefilled syringe presentations of the biosimilar, the autoinjector had a 1.7-point lower pain score compared with prefilled syringe (95% CI, —3.3 to –0.1; P = .035).

The biosimilar, write the authors, has a “significant advantage” over the reference adalimumab in terms of injection pain.

References

1. Alten R, Genovese MC, Muninz AR, Kellner H. Long-term safety, immunogenicity and efficacy in randomized, double-blind, and open-label extension studies comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product in patients with rheumatoid arthritis. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019, June 12-15, 2019; Madrid, Spain. Abstract SAT0132.

2. Alten R, Genovese MC, Boyce M, Yonemura T, Ito T, Kellner H. Systematic analysis of injection-site pain caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus administration of the adalimumab reference product via different delivery methods. Presented at: The European League Against Rheumatism European Congress of Rheumatology 2019, June 12-15, 2019; Madrid, Spain. Abstract FRI0075.