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| Name | Symbol | Market | Type |
|---|---|---|---|
| Roche Holdings Ltd AG (QX) | USOTC:RHHBY | OTCMarkets | Depository Receipt |
| Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 1.20 | 3.03% | 40.76 | 40.59 | 40.80 | 40.80 | 40.12 | 40.15 | 2,775,124 | 22:20:00 |
From Jul 2022 to Jul 2024
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)
Copyright (c) 2022 Dow Jones & Company, Inc.
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