Amgen has taken a key step toward obtaining European Union approval of its ABP 501 biosimilar therapy for rheumatoid arthritis (RA) and other conditions.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that the EU authorize ABP 501 as a biosimilar to AbbVie’s Humira (adalimumab) for adults with moderate to severe rheumatoid arthritis. The European Commission will make the final decision on whether to approve ABP 501.
A biosimilar is a biological product similar to a treatment that the European Medicines Agency (EMA) or U.S. Food and Drug Administration (FDA) has already authorized. It is often cheaper than the original therapy.
The EMA also recommended ABP 501’s use as a treatment for adults with psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis, moderate to severe chronic plaque psoriasis, moderate to severe hidradenitis suppurativa, moderate to severe ulcerative colitis, and non-infectious intermediate, posterior and panuveitis cases of moderate to severe Crohn’s disease.
In addition, the committee recommended ABP 501 for children with four conditions: moderate to severe Crohn’s disease in children 6 and older; severe chronic plaque psoriasis in those 4 and older; enthesitis-related arthritis in children 6 and older; and polyarticular juvenile idiopathic arthritis in those 2 and older.
“The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release. “This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”
ABP 501 is an anti-TNF-α monoclonal antibody that the FDA approved as a biosimilar in September 2016 under the brand name Amjevita (adalimumab-atto).
Clinical trial results were part of the evidence the EMA weighed in deciding to recommend ABP 501.
Amgen conducted two Phase 3 clinical trials to evaluate ABP 501’s biosimilarity to Humira in patients with moderate to severe rheumatoid arthritis (NCT01970475) and in patients with moderate to severe plaque psoriasis (NCT01970488).
In both trials, ABP 501 displayed no meaningful differences from Humira as a therapy. It also showed comparable safety and immunogenicity, or an ability to trigger an immune response.
Amgen also presented sufficient data to support the notion that Humira patients could make a safe transition to ABP 501.