FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)
09 December 2022 - 11:30PM
FDA Accepts Biogen Biologics License Application for BIIB800, A
Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)
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
candidate referencing ACTEMRA®1 (tocilizumab), an
anti-interleukin-6 receptor monoclonal antibody.
ACTEMRA® is indicated for several indications, including
moderate to severe rheumatoid arthritis in adults as well as
juvenile idiopathic polyarthritis and systemic juvenile idiopathic
arthritis.
“The FDA filing is supported by Phase 3 data from a comparative
clinical trial demonstrating equivalent efficacy and a comparable
safety and immunogenicity profile to the reference product,” said
Ian Henshaw, Head of Global Biosimilars at Biogen. “We look forward
to working with regulators to bring this potential treatment option
for people with immune mediated inflammatory diseases.”
As previously reported, positive Phase 32 data for BIIB800 up to
week 24 was presented at the European Congress of Rheumatology on
June 3, 2022. The BIIB800 clinical program included a Phase 3
multicenter, multinational, randomized, double-blind,
parallel-group, active-control global study, designed to evaluate
the efficacy, safety, pharmacokinetics and immunogenicity of
BIIB800 compared to ACTEMRA® in 621 patients with moderate to
severe rheumatoid arthritis with inadequate response to
methotrexate. The data from the Phase 3 comparative clinical trial
demonstrated that the biosimilar candidate BIIB800 has equivalent
efficacy and comparable safety and immunogenicity profile to the
reference tocilizumab product. The one-year Phase 3 results were
presented at the American College of Rheumatology (ACR) on November
10, 2022.
Biosimilars are biological products that have been demonstrated
to be similar in efficacy and safety to the originator’s reference
product, with the advantage that they offer healthcare savings and
promote sustainable access to therapies. Savings in the United
States from 2020 until 2024 as a result of biosimilars across
therapeutic areas are projected to exceed $100 billion.3
In September 2022, the Marketing Authorization Application (MAA)
for BIIB800 was accepted for review by the European Medicines
Agency (EMA).
Biogen announced in April 2021 that it entered into a
commercialization and license agreement with Bio-Thera Solutions,
Ltd. to develop, manufacture and commercialize BIIB800. Biogen has
exclusive regulatory, manufacturing and commercial rights to
BIIB800 in all countries excluding China (including Hong Kong,
Macau and Taiwan).
About BiogenAs 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
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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.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.
References:
- 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-in-the-united-states-2020-2024
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INVESTOR
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