Biogen: EMA Accepts Application for RoActemra Biosimilar
September 30 2022 - 7:56AM
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 RoActemra.
The Cambridge, Mass., drugmaker said the application includes
positive data from a Phase 3 study evaluating the efficacy, safety,
pharmacokinetics and immunogenicity of BIIB800 compared to
RoActerma, which is marketed in the U.S. as Acterma.
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 reported Actemra/RoActemra sales of roughly $1.5 billion
in the second quarter. The drug is approved in more than 100
countries for the treatment of rheumatoid arthritis.
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
September 30, 2022 07:41 ET (11:41 GMT)
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