ABP 501 (adalimumab biosimilar) meets endpoint in Phase III trial for rheumatoid arthritis- Amgen

Amgen has presented detailed findings from a head-to-head Phase III study comparing the safety, efficacy and immunogenicity of ABP 501 (adalimumab biosimilar) with Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis. The study met the primary endpoint, which was achievement of ACR20 (20% or greater improvement in ACR assessment) at week 24. At week 24, 74.6% of patients in the ABP 501 group and 72.4% in the adalimumab group met the ACR20 response criteria. The risk ratio of ACR20 was 1.039 with the two-sided 90 percent CI of 0.954-1.133, which fell within the predefined equivalence margin.

Secondary endpoints included the achievement of ACR50 and ACR70 (a 50 or 70 percent improvement in ACR assessment) within the predefined equivalence margin. At week 24, patients treated with ABP 501 compared with those treated with adalimumab achieved ACR50 (49.2 vs. 52.0 percent) and ACR70 (26.0 vs. 22.9 percent), respectively. The incidence of treatment-emergent adverse events (TEAEs) was 50% for ABP 501 and 55% for adalimumab. The most frequently reported TEAEs (for ABP 501 and adalimumab, respectively) were nasopharyngitis (6.4 vs. 7.3 percent) and headache (4.5 vs. 4.2 percent). The results were presented at the 2015 American College of RheumatologyAssociation of Rheumatology Health Professionals meeting.

Comment: Humira goes off patent in the EU in 2016. More than 550 biosimilars are now in development worldwide, and demand is set to surge as a result of patent expiration on major biologics.