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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 | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 30.09 | 30.32 | 30.36 | 216 | 14:20:58 |
From May 2022 to May 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 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)
Copyright (c) 2022 Dow Jones & Company, Inc.
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