EU Approval of Humira Biosimilar, ABP501, to Treat Adults and Children with IBD Favored

EU Approval of Humira Biosimilar, ABP501, to Treat Adults and Children with IBD Favored
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.
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