The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing of ABP 501, a biosimilar for Abbvie’s Humira (adalimumab). The committee recommended approval for all available indications, including moderate-to-severe rheumatoid arthritis, chronic plaque psoriasis, Crohn’s disease and ulcerative colitis.
ABP 501 is the first Humira biosimilar recommended for EMA Approval. In September 2016, ABP 501 won FDA approval in the US, where it goes by the brand name AMJEVITA™ (adalimumab-atto). AMJEVITA is currently not available commercially, though, amid ongoing patent litigation in the U.S. Humira is Abbvie’s biggest seller, accounting for approximately $4 billion of AbbVie’s $6.7 billion earnings last quarter.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. (Source: Amgen.com and news.abbvie.com)