|
 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.
[to top of second column] |
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.
(Reporting by Deena Beasley in Los Angeles; Editing by Peter Cooney
and Himani Sarkar)
[© 2017 Thomson Reuters. All rights
reserved.] Copyright 2017 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
