Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar Candidate Referencing RoACTEMRA® (tocilizumab)
30 September 2022 - 9:00PM
Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar
Candidate Referencing RoACTEMRA® (tocilizumab)
Biogen Inc. (Nasdaq: BIIB) announced that the European Medicines
Agency (EMA) has accepted the Marketing Authorization Application
(MAA) for BIIB800, a biosimilar candidate referencing RoACTEMRA®1
(tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.
RoACTEMRA® is indicated in Europe as an intravenous formulation for
severe, active and progressive rheumatoid arthritis in adults not
previously treated with methotrexate, moderate to severe rheumatoid
arthritis in adults who have either responded inadequately to, or
who were intolerant to, previous therapy with one or more
disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis
factor (TNF) antagonists, as well as for the treatment of patients
from 2 years of age with juvenile idiopathic polyarthritis who have
responded inadequately to previous therapy with methotrexate,
patients from 2 years of age with active systemic juvenile
idiopathic arthritis who have responded inadequately to prior
therapy with NSAIDs and systemic corticosteroids. RoACTEMRA® is
also used to treat chimeric antigen receptor (CAR) T cell-induced
severe or life-threatening cytokine release syndrome in adults or
paediatric patients 2 years of age or older, and severe coronavirus
disease 2019 (COVID-19) in adults who are receiving systemic
corticosteroids and require supplemental oxygen or mechanical
ventilation. The MAA includes positive Phase 32 data for BIIB800
from the clinical program of a multicenter, multinational,
randomized, double-blind, parallel-group, active-control study,
designed to evaluate the efficacy, safety, pharmacokinetics (PK)
and immunogenicity of BIIB800 compared to RoACTEMRA® in 621
patients with moderate to severe rheumatoid arthritis with
inadequate response to methotrexate. The Phase 3 data from the
comparative clinical trial demonstrated that the biosimilar
candidate BIIB800 has equivalent efficacy and a comparable PK,
safety and immunogenicity profile to reference tocilizumab and
these positive results were presented at the European Congress of
Rheumatology on June 3, 2022.
“The EMA filing acceptance for BIIB800 brings us a step closer
to potentially offering broader patient access to another more
affordable and important new biosimilar treatment option in Europe,
and we look forward to continued engagement with the EMA throughout
the review process,” said Ian Henshaw, Head of Global Biosimilars
at Biogen. “If approved, BIIB800 will be a valuable treatment
option for people with chronic immune mediated inflammatory
diseases. We believe our biosimilar offerings are essential as we
collaborate with payers and health authorities with the goal of
generating savings to ensure sustainable healthcare systems.” On
April 8th, 2021, Biogen and Bio-Thera Solutions, Ltd. entered into
a commercialization and license agreement 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).Biosimilars
are products that have been demonstrated to be similar in efficacy
and safety to the originator’s reference product, with the
advantage that they offer cost savings and promote sustainable
access to therapies. Biogen is committed to advancing development,
manufacturing and commercialization of additional biosimilar
candidates with the goal of optimizing the disease management with
biosimilars and helping more people and healthcare systems across
the world to benefit from biologics treatments.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.
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to address the deeply interrelated issues of climate, health, and
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Safe HarborThis 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 and results
that may be achieved through Biogen’s commercialization and license
with Bio-Thera Solutions; the potential benefits, safety and
efficacy of BIIB800; risks and uncertainties associated with drug
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commercial business and pipeline programs; Biogen’s strategy and
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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
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update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
References:
- ACTEMRA®/RoACTEMRA® is a registered
trademark of Genentech, Inc.
-
https://ard.bmj.com/content/annrheumdis/81/Suppl_1/388.2.full.pdf
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