Amgen seeks FDA approval for infliximab biosimilar ABP 710
Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab).
ABP 710 is being studied as a biosimilar candidate to infliximab, which is an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. Infliximab has approval in several regions for the treatment of moderate to severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate to severe Crohn’s disease, psoriatic arthritis, moderate to severe ulcerative colitis and ankylosing spondylitis.
According to Amgen, the active ingredient present in ABP 710 is an anti-TNF monoclonal antibody that has similar amino acid sequence as infliximab. ABP 710 also has the same pharmaceutical dosage form and strength as its reference drug.
The BLA submission for its infliximab biosimilar covers analytical, pharmacokinetic and clinical data in addition to the drug’s pharmacology and toxicology data.
In a phase 3 comparative efficacy, safety and immunogenicity trial, which was carried out in patients having moderate-to-severe rheumatoid arthritis, no confirmed clinically meaningful differences were shown between ABP 710 and infliximab.
David M. Reese – executive vice president of Research and Development at Amgen said: “At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We’re leveraging our deep expertise and heritage in biologics to produce a portfolio of biosimilars to serve patients with the most complex diseases.
“We’re committed to providing patients with serious illnesses access to high-quality biological therapies and look forward to working with the FDA to potentially bring ABP 710 to market.”
Amgen boasts of 10 biosimilars in its portfolio, out of which two have approval in the US while three are approved in the European Union.