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     356  0 Kommentare FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA (tocilizumab) - Seite 2

    About Biogen
    As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and developed the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing one of the industry’s most diversified pipelines in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

    We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - TwitterLinkedInFacebookYouTube.

    Biogen Safe Harbor 
    This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of BIIB800; potential benefits of our collaboration with Bio-Thera; risks and uncertainties associated with drug development and commercialization; the potential of Biogen’s commercial business and pipeline programs; Biogen’s strategy and plans; and potential cost healthcare savings related to biosimilars. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

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    FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA (tocilizumab) - Seite 2 CAMBRIDGE, Mass., Dec. 09, 2022 (GLOBE NEWSWIRE) - Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar …