Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA® [Yahoo! Finance]
Biogen Inc. (BIIB)
Last biogen inc. earnings: 4/22 07:12 am
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Source: Yahoo! Finance
CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA ®1 . The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. The CHMP's positive opinion will now be referred to the European Commission (EC), which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI (etanercept), IMRALDI (adalimumab) and FLIXABI (infliximab), offering
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BIIB
Earnings
- 4/25/24 - Beat
BIIB
Sec Filings
- 5/3/24 - Form 4
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- BIIB's page on the SEC website