ABP501, a biosimilar of Humira (adalimumab), was recommended for approval in the European Union to treat adults and some children with various inflammatory diseases, including inflammatory bowel disease (IBD), by the Committee for Medicinal Products for Human Use (CHMP).
CHMP, an arm of the European Medicines Agency (EMA), issued its positive opinion for ABP 501 as a treatment for adults with IBD, including moderate-to-severe Crohn’s disease and ulcerative colitis, rheumatoid arthritis and psoriatic arthritis (PA), among other diseases. The opinion also recommends the treatment for certain pediatric patients, including children ages 6 and older with moderate-to-severe Crohn’s. The European Commission will now take the opinion under consideration, and issue a decision.
ABP 501 is a biosimilar to Humira, an anti-TNF-α monoclonal antibody approved in many countries for the treatment of several inflammatory diseases. As a biosimilar, ABP 501’s active ingredient has the same amino acid sequence as Humira (biosimilar drugs must be similar in clinically meaningful ways to the referenced biological product).
ABP 501, under the brand name Amjevita (adalimumab-atto), was approved by the U.S. Food and Drug Administration (FDA) in September 2016 to treat multiple inflammatory diseases, including moderately to severely active Crohn’s and ulcerative colitis. In the U.S., the biosimilar is for use in adult IBD patients only.
The EMA submission made by Amgen, the biosimilar’s developer, was grounded on data from two Phase 3 studies, supporting biosimilarity to Humira, that were conducted in moderate-to-severe plaque psoriasis (NCT01970488) and moderate-to-severe rheumatoid arthritis (NCT01970475) patients.
Both trials each met their primary endpoint with comparable safety and immunogenicity (immune system response to the drug) and with no clinically meaningful differences to Humira. The submission also includes data supporting the transition of Humira patients to ABP 501.
If approved, the biosimilar will be available in all 28 EU states, and possibly in Norway, Liechtenstein and Iceland as well.
“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.”