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Samsung, Biogen version of AbbVie's Humira approved in Europe
August 25, 2017 / 1:00 AM / 4 months ago

Samsung, Biogen version of AbbVie's Humira approved in Europe

Aug 24 (Reuters) - Biogen Inc’s version of AbbVie Inc’s blockbuster arthritis drug Humira has been approved by European Union regulators, Biogen and joint venture partner Samsung Biologics said on Thursday.

The new drug, Imraldi, marks the third European Commission approval for “biosimilar” versions from joint venture Samsung Bioepis of drugs in a class known as TNF inhibitors.

Biosimilar copies of expensive biotech drugs are gaining momentum in Europe, which has been faster to adopt their use than the United States, and their potential to take business from companies making the original products is being monitored closely by investors.

Imraldi was approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

Last year, Samsung Bioepis received European Commission marketing authorization for Benepali, a biosimilar version of Amgen Inc’s Enbrel and for Flixabi, a version of Remicade, which is sold by Johnson & Johnson.

Earlier this year, Amgen won European approval for the first copy of Humira, also called adalimumab.

The green lights clear the way for biosimilar copies of Humira to be launched in Europe in due course, although lawyers do not expect that to happen before October 2018, given the patents protecting adalimumab.

Anti-TNF therapies represent some of the EU’s largest drug expenditures, costing an estimated $9 billion a year, Biogen said in a statement. The company estimated that having lower-cost versions of the drugs in Europe could generate savings of over $11 billion between the patent expiry date of each reference product and 2020.

Reporting by Deena Beasley in Los Angeles; Editing by Peter Cooney

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