HomeBiotechnologyFDA Accepts Biogen Biologics License Software for BIIB800, A Biosimilar Candidate Referencing...

FDA Accepts Biogen Biologics License Software for BIIB800, A Biosimilar Candidate Referencing ACTEMRA(R) (tocilizumab) – Bio Tech Winners

Final Up to date on December 9, 2022 by GlobeNewsWire

CAMBRIDGE, Mass., Dec. 09, 2022 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) – introduced that the U.S. Meals and Drug Administration (FDA) has accepted for assessment the abbreviated Biologics License Software (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA(R)1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.

ACTEMRA(R) is indicated for a number of indications, together with average to extreme rheumatoid arthritis in adults in addition to juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.

“The FDA submitting is supported by Section 3 information from a comparative medical trial demonstrating equal efficacy and a comparable security and immunogenicity profile to the reference product,” mentioned Ian Henshaw, Head of International Biosimilars at Biogen. “We look ahead to working with regulators to deliver this potential remedy choice for folks with immune mediated inflammatory illnesses.”

As beforehand reported, constructive Section 32 information for BIIB800 as much as week 24 was introduced on the European Congress of Rheumatology on June 3, 2022. The BIIB800 medical program included a Section 3 multicenter, multinational, randomized, double-blind, parallel-group, active-control world research, designed to judge the efficacy, security, pharmacokinetics and immunogenicity of BIIB800 in comparison with ACTEMRA(R) in 621 sufferers with average to extreme rheumatoid arthritis with insufficient response to methotrexate. The info from the Section 3 comparative medical trial demonstrated that the biosimilar candidate BIIB800 has equal efficacy and comparable security and immunogenicity profile to the reference tocilizumab product. The one-year Section 3 outcomes had been introduced on the American School of Rheumatology (ACR) on November 10, 2022.

Biosimilars are organic merchandise which have been demonstrated to be related in efficacy and security to the originator’s reference product, with the benefit that they provide healthcare financial savings and promote sustainable entry to therapies. Financial savings in the US from 2020 till 2024 because of biosimilars throughout therapeutic areas are projected to exceed $100 billion.3

In September 2022, the Advertising Authorization Software (MAA) for BIIB800 was accepted for assessment by the European Medicines Company (EMA).

Biogen introduced in April 2021 that it entered right into a commercialization and license settlement with Bio-Thera Options, Ltd. to develop, manufacture and commercialize BIIB800. Biogen has unique regulatory, manufacturing and business rights to BIIB800 in all nations excluding China (together with Hong Kong, Macau and Taiwan).

About BiogenAs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide revolutionary therapies for folks residing with severe neurological illnesses in addition to associated therapeutic adjacencies. One of many world’s first world biotechnology firms, Biogen was based in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Right this moment, Biogen has a number one portfolio of medicines to deal with a number of sclerosis, has launched the primary accredited remedy for spinal muscular atrophy, and developed the primary and solely accredited remedy to handle a defining pathology of Alzheimer’s illness. Biogen can also be commercializing biosimilars and specializing in advancing one of many trade’s most diversified pipelines in neuroscience that can remodel the usual of take care of sufferers in a number of areas of excessive unmet want.

We routinely submit data that could be vital to buyers on our web site at www.biogen.com. Observe us on social media – Twitter, LinkedIn, Fb, YouTube.

Biogen Secure Harbor This information launch accommodates forward-looking statements, together with statements made pursuant to the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995, referring to the potential advantages, security and efficacy of BIIB800; potential advantages of our collaboration with Bio-Thera; dangers and uncertainties related to drug improvement and commercialization; the potential of Biogen’s business enterprise and pipeline packages; Biogen’s technique and plans; and potential value healthcare financial savings associated to biosimilars. These forward-looking statements could also be accompanied by phrases comparable to “intention,” “anticipate,” “imagine,” “may,” “estimate,” “count on,” “forecast,” “intend,” “could,” “plan,” “potential,” “potential,” “will,” “would” and different phrases and phrases of comparable that means. Drug improvement and commercialization contain a excessive diploma of threat, and solely a small variety of analysis and improvement packages lead to commercialization of a product. Ends in early stage medical trials might not be indicative of full outcomes or outcomes from later stage or bigger scale medical trials and don’t guarantee regulatory approval. You shouldn’t place undue reliance on these statements or the scientific information introduced.

These statements contain dangers and uncertainties that would trigger precise outcomes to vary materially from these mirrored in such statements, together with with out limitation, dangers that dangers of sudden prices or delays or different sudden hurdles; uncertainty of success within the improvement and potential commercialization of BIIB800, which can be impacted by, amongst different issues, sudden considerations that will come up from extra information or evaluation, the prevalence of adversarial security occasions, failure to acquire regulatory approvals in sure jurisdictions, failure to guard and implement information, mental property and different proprietary rights and uncertainties referring to mental property claims and challenges; dangers of authorized actions, regulatory scrutiny or different challenges to biosimilars; the direct and oblique impacts of the continued COVID-19 pandemic on Biogen’s enterprise, outcomes of operations and monetary situation; the dangers of doing enterprise internationally, together with foreign money trade fee fluctuations; product legal responsibility claims; and third occasion collaboration dangers. The foregoing units forth many, however not all, of the elements that would trigger precise outcomes to vary from Biogen’s expectations in any forward-looking assertion. Traders ought to take into account this cautionary assertion, in addition to the danger elements recognized in Biogen’s most up-to-date annual or quarterly report and in different stories Biogen has filed with the U.S. Securities and Alternate Fee. These statements are primarily based on Biogen’s present beliefs and expectations and communicate solely as of the date of this information launch. Biogen doesn’t undertake any obligation to publicly replace any forward-looking statements, whether or not because of new data, future developments or in any other case.


ACTEMRA(R) is a registered trademark of Genentech, Inc.https://ard.bmj.com/content material/annrheumdis/81/Suppl_1/388.2.full.pdf Leng X, et al. Ann Rheum Dis. 2022;81(suppl. 1):388IQVIA Institute for Human Knowledge Science. Biosimilars in the US 2020-2024 Competitors, Financial savings, and Sustainability Institute Report, Sep 29, 2020. Out there at: https://www.iqvia.com/insights/the-iqvia-institute/stories/biosimilars-in-the-united-states-2020-2024 MEDIA CONTACT:BiogenJack Cox+ 1 210 544 7920public.affairs@biogen.comINVESTOR CONTACT:BiogenMike Hencke+1 781 464 2442IR@biogen.com



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