356 0 Kommentare FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA (tocilizumab) - Seite 3

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, risks that risks of unexpected costs or delays or other unexpected hurdles; uncertainty of success in the development and potential commercialization of BIIB800, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition; the risks of doing business internationally, including currency exchange rate fluctuations; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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ACTEMRA is a registered trademark of Genentech, Inc.
https://ard.bmj.com/content/annrheumdis/81/Suppl_1/388.2.full.pdf Leng X, et al. Ann Rheum Dis. 2022;81(suppl. 1):388
IQVIA Institute for Human Data Science. Biosimilars in the United States 2020–2024 Competition, Savings, and Sustainability Institute Report, Sep 29, 2020. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars ...