資料來源：https://www.reuters.com/article/us-biogen-humira-idUSKCN1B5041

A biosimilar version of AbbVie Inc’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc and Samsung Biologics, was approved by European Union regulators, the partners said on Thursday.

The new drug, Imraldi, marks the third European Commission approval for “biosimilar” versions from the 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.

“As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics,” Jean-Paul Kress, head of global therapeutic options at Biogen, said in a statement.

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.

A Samsung Bioepis spokesman said both Benepali and Flixabi began launching in 2016 in Europe, but the company was unable to provide any details on a timeline for Imraldi's launch.

Anti-TNF therapies represent some of the EU's largest drug expenses, costing an estimated $9 billion a year, Biogen said. The company estimates 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.