Amgen reports positive phase 3 results for RA biosimilar treatment

Amgen has announced that the results of a phase 3 clinical trial showed ABP 501, a biosimilar candidate to Humira, met key endpoints in patients with moderate-to-severe rheumatoid arthritis.

The randomized, active-controlled, double-blind study compared the safety, efficacy and immunogenicity of the tumor necrosis factor (TNF)-inhibitor, ABP 501, with Humira (adalimumab, AbbVie). ABP 501 has the same amino acid sequence as the TNF-inhibitor monoclonal antibody, adalimumab.

Adults with moderate-to-severe rheumatoid arthritis (RA) who failed previous treatment with methotrexate were included in the study. The 526 study participants underwent a 4-week screening phase, a 22-week treatment phase and a 2-week follow-up phase. Researchers randomly assigned the participants to receive either ABP 501 40 mg or adalimumab 40 mg subcutaneously every 2 weeks. The study’s primary endpoint, a 20% or greater improvement in American College of Rheumatology assessment (ACR 20), was assessed at week 24, according to a press release.

Study results showed ACR 20 for ABP 501 was within the prescribed margin compared with adalimumab. Additionally, ABP 501’s safety and immunogenicity were comparable to that of adalimumab, according to the release.

“The positive results from Amgen’s biosimilar phase 3 rheumatoid arthritis study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release. “Amgen’s success on both our ABP 501 psoriasis and rheumatoid arthritis studies underscores our expertise in the research and development of high-quality biologic therapies.”

Amgen is currently developing nine biosimilar molecules and expects to release five of them between 2017 and 2019, according to the release.

Reference: www.amgen.com.