Researchers recently compared the safety, efficacy, and pharmacodynamics of adalimumab manufactured by Hetero and marketed as Mabura, versus reference adalimumab manufactured by Abbvie and marketed as Humira.
“Adalimumab (Humira®, AbbVie Inc., USA) was first approved in December 2002 by the US Food and Drug Administration (FDA) and is currently approved for multiple immune-mediated inflammatory diseases in addition to RA [15, 16]. Biosimilar development has become imperative to improve patient’s accessibility to [biologic disease-modifying antirheumatic drugs] with potentially low drug prices and resulting in reduction of treatment cost for healthcare systems and patients,” the study authors explained.
A total of 168 active RA patients were randomized 2:1 to receive either test (n = 112) or reference (n = 56) product for 24 weeks with concomitant methotrexate. Eligible patients were aged between 18 and 65 years with at least six swollen joints (66-joint count), at least six tender/painful joints (68-joint count), C-reactive protein level > 6 mg/L, and erythrocyte sedimentation rate >28 mm/h. The main outcome was the proportion of patients achieving 12-week American College of Rheumatology 20 (ACR20) criteria. Secondary outcomes included changes in Disease Activity Score of 28 joints–C-reactive protein (DAS28-CRP), Health Assessment Questionnaire–Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24.
At week 12, the proportion of patients achieving ACR20 responses was similar between the test (96.43%) and reference (96.43%) groups in intention-to-treat (ITT) analysis. There were no significant differences between the groups in the proportion of patients who attained ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (P>0.05 for all). DAS28-CRP and HAQ-DI did not significantly differ between the groups. A total of 88 adverse events (AEs) were reported by 54 patients; 60 AEs were reported in 34 Mabura patients and 28 AEs were reported in 20 Humira patients. One patient in each group reported a serious AE (sinusitis and viral infection), both of which were completely resolved. There were no reported deaths or life-threatening AEs.
The study was published in BMC Rheumatology.
“Results of this study demonstrated no clinically meaningful difference in efficacy, pharmacodynamics, and safety between test and reference treatment groups. Hence, the test adalimumab is being equally efficacious and safe biosimilar to the reference adalimumab for treatment of active RA in patients concomitantly on [methotrexate] therapy,” the researchers concluded.