Amgen Files First Marketing Authorization Application for Humira® in the EU

Following Amgen’s U.S. biosimilar application for AbbVie’s Humira® (adalimumab) in late November, Amgen has now filed a Marketing Authorization Application for ABP 501, a biosimilar candidate to Humira®, with the European Medicines Agency (EMA). Amgen believes this submission is the first adalimumab biosimilar application submitted in the European Union (EU).

Humira® is indicated in Europe for use in adults with moderate to severe rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's Disease, moderately to severely active ulcerative colitis and active moderate to severe hidradenitis suppurativa.

An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbraith

Like its U.S. biosimilar application, Amgen supported its EU biosimilar application with data from Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.1 The studies demonstrated clinical equivalence to the reference biologic (Humira®) in the study patient populations and a comparable safety profile. Although EMA lacks the authority to designate a biosimilar as ‘interchangeable,’ data to support the transition of Humira® patients to ABP 501 are included in the submission.

Humira®, a monoclonal antibody against TNF-alpha, is the world’s best-selling prescription drug, with over $12 billion in sales last year. AbbVie has predicted annual sales will hit $18 billion by 2020.2

More than 700 follow-on biologic therapies are currently in development, with 245 biopharma companies and institutions now developing or already marketing biosimilars throughout the world. Europe is ahead of the U.S. when it comes to biosimilar adoption. The EMA approved its first biosimilar in 2006, while the first approval in the U.S. was in March 2015. EMA has approved 21 biosimilars. Two biosimilar approvals have been withdrawn; one for filgrastim in April 2011 and one for somatropin in May 2012, leaving a total of 19 biosimilars approved for use in Europe. To date, the U.S. has only approved one biosimilar, Zarxio®, a biosimilar to Neupogen®. As of July 31, 2015, 57 proposed biosimilar products to 16 different reference products were enrolled in FDA’s biosimilar review program.3

For more information on Amgen’s U.S. biosimilar application for adalimumab, see our previous blog post entitled, “Amgen Files Application for Humira Biosimilar,” available at: http://blognetwork.kilpatricktownsend.com/hlt/2015/12/01/amgen-files-application-for-humira-biosimilar.

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1 http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-newsArticle&ID=2120167

2 http://www.abbvie.com/newsroom/stories/2015/10/well-positioned-for-success-q3results.html

3 http://www.fda.gov/NewsEvents/Testimony/ucm463036.htm

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