* CHMP positive opinion is based on a robust analytical, non-clinical and

    clinical data package comparing TOFIDENCE(TM) to the reference product
    ROACTEMRA(®)

CAMBRIDGE, Mass., April 25, 2024 (GLOBE NEWSWIRE) -- Biogen
(http://www.biogen.com) Inc. (Nasdaq: BIIB) today announced that the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) adopted a positive opinion for TOFIDENCE(TM) (tocilizumab), a biosimilar
monoclonal antibody referencing ROACTEMRA(®1). The intravenous formulation of
TOFIDENCE has been recommended for approval for the treatment of moderate to
severely active rheumatoid arthritis, polyarticular juvenile idiopathic
arthritis, systemic juvenile idiopathic arthritis and COVID-19.
The CHMP's positive opinion will now be referred to the European Commission
(EC), which will decide whether to grant marketing authorization for TOFIDENCE.
If a marketing authorization is granted by the EC, TOFIDENCE will be an addition
to the existing biosimilars portfolio of three widely prescribed anti-TNF
biosimilars commercialized by Biogen in Europe: BENEPALI (etanercept), IMRALDI
(adalimumab) and FLIXABI (infliximab), offering an extension to the cost-
effective treatment options with an additional mechanism of action.
"The positive CHMP recommendation for TOFIDENCE marks another positive step
toward helping more people with inflammatory and immune-mediated conditions gain
access to leading therapies," said Ian Henshaw, Global Head of Biosimilars at
Biogen. "Positive CHMP recommendation for TOFIDENCE is testament to our
continuing efforts to develop and deliver high-quality and proven biologic
medicines to more patients, healthcare providers and healthcare systems in
Europe."
This positive CHMP opinion on TOFIDENCE was based on the totality of evidence
comprising a comprehensive analytical, non-clinical and clinical data package.
Extensive analytical characterization of the structural, physicochemical, and
biological properties of TOFIDENCE was conducted and supports equivalence with
the reference biologic product. Additionally, a randomized double-blind, single-
dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics,
safety and immunogenicity of TOFIDENCE with both the EU and US reference
tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose,
three-arm, parallel group Phase 3 study compared TOFIDENCE with tocilizumab to
establish equivalent efficacy and comparable pharmacokinetic, safety and
immunogenicity profiles, in subjects with rheumatoid arthritis inadequately
controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a
biosimilar of the reference biologic.
Biogen and Bio-Thera entered into a commercialization and licensing agreement
for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, TOFIDENCE,
developed by Bio-Thera, is to be commercialized by Biogen in the European Union.
Under the agreement, Biogen has exclusive regulatory, manufacturing, and
commercial rights to TOFIDENCE in all countries excluding China (including Hong
Kong, Macau and Taiwan).
About TOFIDENCE (tocilizumab)
TOFIDENCE (tocilizumab), an inteleukin-6 receptor antagonist, is a treatment
developed as a biosimilar to the reference product ROACTEMRA. TOFIDENCE is
indicated for the treatment of moderate to severe active rheumatoid arthritis,
polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic
arthritis and COVID-19.
Indications
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely active rheumatoid arthritis who have
had an inadequate response to, or who were intolerant to, one or more Disease-
Modifying Anti-Rheumatic Drug (DMARD) or tumor necrosis factor (TNF) antagonist.
Adult patients with severe, active and progressive RA not previously treated
with methotrexate (MTX).
In these patients, TOFIDENCE can be given as monotherapy in case of intolerance
to MTX or where continued treatment with MTX is inappropriate.
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic
arthritis who have responded inadequately to previous therapy with MTX. In these
patients, TOFIDENCE(TM) can be given as monotherapy in case of intolerance to MTX
or where continued treatment with methotrexate (MTX) is inappropriate.
Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic
arthritis who have responded inadequately to previous therapy with NSAIDs and
systemic corticosteroids. TOFIDENCE(TM) can be given as monotherapy in case of
intolerance to MTX or where continued treatment with MTX is inappropriate.
Coronavirus disease 2019 (Covid-19)
Adult patients who are receiving systemic corticosteroids and require
supplemental oxygen or mechanical ventilation.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers
innovative science to deliver new medicines to transform patients' lives and to
create value for shareholders and our communities. We apply deep understanding
of human biology and leverage different modalities to advance first-in-class
treatments or therapies that deliver superior outcomes. Our approach is to take
bold risks, balanced with return on investment to deliver long-term growth.
We routinely post information that may be important to investors on our website
at www.biogen.com (https://www.biogen.com/). Follow us on social media -
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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
TOFIDENCE; 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 commercialization of TOFIDENCE(TM), 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 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 speak only as of the date of this news release. Biogen does not
undertake any obligation to publicly update any forward-looking statements.
References:
1. RoActemra(®) is a registered trademark of Genentech, Inc.

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 Biogen                                 Biogen
 Jack Cox                               Chuck Triano
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