ABP 710 filed with FDA as biosimilar to Remicade in various indications.- Amgen.

Amgen announced the submission of a Biologics License Application (BLA) to the FDA for ABP 710, a biosimilar candidate to Remicade (infliximab). ABP 710 is being investigated as a biosimilar candidate to infliximab, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, which is approved in many regions for the treatment of moderate to severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate to severe Crohn's disease, moderate to severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis.

The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase III comparative efficacy, safety and immunogenicity study was conducted in patients with moderate-to-severe rheumatoid arthritis and confirmed no clinically meaningful differences between ABP 710 and infliximab.