Biogen: FDA Accepts Application for Actemra Biosimilar

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 [e-mail]

(END) Dow Jones Newswires

December 09, 2022 08:05 ET (13:05 GMT)

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