Amgen Submits BLA for Proposed Infliximab Biosimilar

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

The BLA contains analytical, pharmacokinetic, and clinical data, as well as pharmacology and toxicology data on the proposed biosimilar. Earlier in 2018, Amgen reported positive topline data from its phase 3 study of the drug in patients with rheumatoid arthritis (RA).

In the study, 588 patients with RA were randomized to receive either the proposed biosimilar or its reference at a dose of 3 mg/kg infused on day 1, at weeks 2 and 6, and every 8 weeks thereafter. The primary end point of the study the proportion of patients achieving 20% or greater improvement as defined by the American College of Rheumatology criteria (ACR20) at week 22. Secondary endpoints included achieving ACR50, ACR70, and disease activity score 28-joint count C reactive protein (DAS28-CRP). The primary end point of ACR20 had a prespecified equivalence margin of ±15%, and the observed upper end of the confidence interval was 15.96%.

The researchers said that their data confirmed the noninferiority of ABP 710 compared with infliximab, but “could not rule out superiority based on its primary efficacy endpoint,” according to Amgen. In addition, the safety profile and immunogenicity were comparable between ABP 710 and the originator.

David M. Reese, MD, executive vice president of research and development at Amgen, said in a statement announcing the BLA submission, "At Amgen, we have spent nearly [4] decades developing, manufacturing, and producing transformative medicines…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."

If the product is eventually approved, it will join 2 existing infliximab biosimilars in the United States market: Inflectra and Renflexis, both of which have struggled to gain US market share against the reference Remicade.

Among the other biosimilar products in Amgen’s pipeline are proposed biosimilars of rituximab (ABP 798), cetuximab (ABP 494), eculizumab (ABP 959) and trastuzumab (ABP 980), the last of which received a Complete Response Letter from the FDA in June 2018.