Biogen: FDA Accepts Application for Actemra Biosimilar
December 09 2022 - 8:20AM
Dow Jones News
By Colin Kellaher
Biogen Inc. on Friday said the European Medicines Agency has
accepted its application seeking approval of BIIB800, a proposed
biosimilar to Roche Holdings AG's blockbuster anti-inflammatory
drug Actemra.
Cambridge, Mass.-based Biogen said the filing is supported by
Phase 3 data from a comparative clinical trial showing equivalent
efficacy and a comparable safety and immunogenicity profile to
Actemra, which is approved for several U.S. indications, including
moderate-to-severe rheumatoid arthritis in adults, as well as
juvenile idiopathic polyarthritis and systemic juvenile idiopathic
arthritis.
Biosimilars are near-copies of biologic drugs that are made from
living cells and are analogous to generic copies of traditional
pill-form medicines.
Roche, which also markets Actemra as RoActemra, reported sales
of roughly $2.2 billion for the drug for the first nine months of
the year.
Biogen has exclusive regulatory, manufacturing and commercial
rights to BIIB800 in all countries excluding China under a 2021
licensing agreement with Bio-Thera Solutions Ltd.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 09, 2022 08:05 ET (13:05 GMT)
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