Amgen submits BLA for Infliximab biosimilar ABP 710 to FDA

Amgen Inc. has officially submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson‘s REMICADE (infliximab). This submission marks a significant milestone in Amgen‘s efforts to expand its biosimilar portfolio.

ABP 710: A Biosimilar to Infliximab

ABP 710 is being developed as a biosimilar to infliximab, an established anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. Infliximab is widely used for the treatment of various conditions including 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, ABP 710 contains an anti-TNF monoclonal antibody with an amino acid sequence identical to that of infliximab. Additionally, the biosimilar is formulated in the same pharmaceutical dosage form and strength as the reference drug, ensuring consistency in its therapeutic profile.

Comprehensive Data Submission

The BLA for ABP 710 includes a comprehensive array of data, covering analytical, pharmacokinetic, and clinical findings. This also encompasses the drug’s pharmacology and toxicology data, reflecting a robust submission designed to demonstrate the biosimilar’s comparability to the reference product.

In a phase 3 comparative trial focusing on efficacy, safety, and immunogenicity, ABP 710 showed no confirmed clinically meaningful differences from infliximab in patients with moderate-to-severe rheumatoid arthritis. This trial reinforces the biosimilar’s potential to provide a comparable therapeutic option to existing treatments.

Statements from Amgen

David M. Reese, Executive Vice President of Research and Development at Amgen, expressed the company’s dedication to advancing biologics, stating, “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’s Biosimilar Portfolio

Amgen’s portfolio currently includes 10 biosimilars, with two approved in the U.S. and three approved in the European Union. The company continues to leverage its extensive experience in biologics to enhance its offerings in the biosimilar space, aiming to provide more treatment options for patients globally.