STADA and Alvotech have launched Uzpruvo®, the first approved
biosimilar to Stelara® in Europe, across a majority of European
countries. This includes the largest markets in the region, where
pricing and reimbursement approvals have been secured for market
entry. The pioneering launch comes immediately upon expiry of
exclusivity rights linked to the European reference molecule
patent, offering patients, physicians and payers expanded access at
the earliest possible opportunity to a life-altering medicine used
in certain indications within gastroenterology1, dermatology and
rheumatology. Launches in further European countries are scheduled
over the coming months, following national price approvals, via a
fully European supply chain.
“Launching Uzpruvo at the earliest opportunity in
Europe’s largest pharmaceutical markets, promotes access by
creating competition,” stated STADA CEO Peter Goldschmidt. “This
opportunity to improve patient access through wider usage of a
life-changing biological treatment emphasizes STADA’s purpose of
Caring for People’s Health as a Trusted Partner.”
“We are delighted at the launch of Uzpruvo in
Europe and to be first-to-market,” commented Robert Wessman, Chief
Executive Officer of Alvotech. “This launch symbolizes the
robustness of our platform, the value of our partnership with
STADA, and our collective focus on the importance of
biosimilars.”
In January 2024, Uzpruvo became the first
ustekinumab biosimilar to be approved by the European Commission as
having equivalent efficacy, safety, pharmacokinetics and
immunogenicity to the Stelara® reference product.2 Uzpruvo is
indicated for Crohn’s disease and psoriatic arthritis in adults, as
well as plaque psoriasis in adults and children aged from 6 years.
Uzpruvo® is currently not approved for the ulcerative colitis
indication, since the originator still has exclusivity for this
indication.
Uzpruvo is offered in a pre-filled syringe format
featuring a thinner needle than the reference product and is
latex-free to minimize the risk of allergic reactions. Uzpruvo was
developed, and is manufactured and packaged, entirely within
Europe, and has a 36-month shelf life.
“With comparable safety, efficacy and
immunogenicity, Uzpruvo gives clinicians an opportunity for a
seamless and simple switch for their patients, who can benefit from
a thinner needle and latex-free syringe,” commented STADA’s Global
Specialty Head, Bryan Kim. “Physicians and patients can have full
confidence that STADA has more than 15 years of experience in
enhancing patient access through high-quality biosimilars in
Europe, having launched our first biosimilar in 2008.”
Ustekinumab is the second immunology biosimilar
brought to market through the strategic partnership between STADA
and Alvotech, following the 2022 launch of the Hukyndra
high-concentration, citrate-free adalimumab therapy. The partners
also recently announced a development, manufacturing and marketing
alliance for a proposed biosimilar to Prolia®/Xgeva® (denosumab)
candidate, AVT03. Alvotech is responsible for development and
manufacturing of biosimilars within the partnership at its facility
in Reykjavik, Iceland, that benefits from nearly 100% domestically
produced renewable energy, including geothermal and hydroelectric
power which is aligned with both companies’ core commitments to
sustainability.
Overall, Uzpruvo is STADA’s seventh biosimilar
supplied in Europe, with the German group also offering biosimilars
in the bone health, nephrology, oncology and ophthalmology
therapeutic sectors, alongside differentiated specialty therapies
in nephrology and neurology.
Alvotech is a global leader in the biosimilar space
and boasts a portfolio and pipeline of 11 biosimilars and
biosimilar candidates covering a wide variety of indications.
Alvotech, through its partnership network has now launched
biosimilar to Stelara in Canada, Japan, and now in Europe.
About STADA Arzneimittel AG STADA
Arzneimittel AG is headquartered in Bad Vilbel, Germany. The
company focuses on a three-pillar strategy consisting of consumer
healthcare products, generics and specialty pharma. Worldwide,
STADA Arzneimittel AG sells its products in approximately 115
countries. In financial year 2023, STADA achieved group sales of
EUR 3,735 million and reported earnings before interest, taxes,
depreciation and amortization (EBITDA) of EUR 802 million. As of 31
December 2023, STADA employed 11,667 people worldwide.
About AlvotechAlvotech is a
biotech company, founded by Robert Wessman, focused solely on the
development and manufacture of biosimilar medicines for patients
worldwide. Alvotech seeks to be a global leader in the biosimilar
space by delivering high quality, cost-effective products, and
services, enabled by a fully integrated approach and broad in-house
capabilities. Alvotech has launched two biosimilars. The current
development pipeline includes nine disclosed biosimilar candidates
aimed at treating autoimmune disorders, eye disorders,
osteoporosis, respiratory disease, and cancer. Alvotech has formed
a network of strategic commercial partnerships to provide global
reach and leverage local expertise in markets that include the
United States, Europe, Japan, China, and other Asian countries and
large parts of South America, Africa and the Middle East.
Alvotech’s commercial partners include Teva Pharmaceuticals, a US
affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA
Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma
(EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr.
Reddy’s (US, EU), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New
Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada),
Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH
(Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia,
India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and
North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega
Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus
Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and
South Korea). Each commercial partnership covers a unique set of
product(s) and territories. Except as specifically set forth
therein, Alvotech disclaims responsibility for the content of
periodic filings, disclosures and other reports made available by
its partners. For more information, please visit www.alvotech.com.
None of the information on the Alvotech website shall be deemed
part of this press release.
Forward Looking StatementsCertain
statements in this communication may be considered “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. Forward-looking statements
generally relate to future events or the future financial operating
performance of Alvotech and may include, for example, Alvotech’s
expectations regarding its ability to satisfy conditions precedent
to close the transaction and draw down the loan, to comply with the
covenants of the Facility and to exercise its rights under the
facility, the expected use of proceeds from the Facility, potential
future financings or strategic transactions, Alvotech’s competitive
advantages, business prospects and opportunities including product
launches, pipeline product development, revenue and
diversification, future plans and intentions, results, level of
activities, performance, goals or achievements or other future
events, regulatory submissions, review and interactions, the
potential approval and commercial launch of its product candidates,
the timing of regulatory approval, and market launches. In some
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such as “may”, “should”, “expect”, “intend”, “will”, “estimate”,
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to risks, uncertainties, and other factors which could cause actual
results to differ materially from those expressed or implied by
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are based upon estimates and assumptions that, while considered
reasonable by Alvotech and its management, are inherently uncertain
and are inherently subject to risks, variability, and
contingencies, many of which are beyond Alvotech’s control. Factors
that may cause actual results to differ materially from current
expectations include, but are not limited to: (1) the ability to
raise substantial additional funding, which may not be available on
acceptable terms or at all; (2) the ability to maintain stock
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affected by other economic, business, and/or competitive factors;
(5) Alvotech’s estimates of revenue, expenses and profitability;
(6) Alvotech’s ability to develop, manufacture and commercialize
the products and product candidates in its pipeline; (7) the
ability of Alvotech or its partners to enroll and retain patients
in clinical studies; (8) the ability of Alvotech or its partners to
gain approval from regulators for planned clinical studies, study
plans or sites; (9) the ability of Alvotech’s partners to conduct,
supervise and monitor existing and potential future clinical
studies, which may impact development timelines and plans; (10)
Alvotech’s ability to obtain and maintain regulatory approval or
authorizations of its products, including the timing or likelihood
of expansion into additional markets or geographies; (11) the
success of Alvotech’s current and future collaborations, joint
ventures, partnerships or licensing arrangements; (12) Alvotech’s
ability, and that of its commercial partners, to execute their
commercialization strategy for approved products; (13) Alvotech’s
ability to manufacture sufficient commercial supply of its approved
products; (14) the outcome of ongoing and future litigation
regarding Alvotech’s products and product candidates; (15) the
impact of worsening macroeconomic conditions, including rising
inflation and interest rates and general market conditions,
conflicts in Ukraine, the Middle East and other global geopolitical
tension, on the Company’s business, financial position, strategy
and anticipated milestones; (16) Alvotech’s ability to meet the
conditions precedent to close Facility and comply with the
covenants of the Facility and (17) other risks and uncertainties
set forth in the sections entitled “Risk Factors” and “Cautionary
Note Regarding Forward-Looking Statements” in documents that
Alvotech may from time to time file or furnish with the SEC. There
may be additional risks that Alvotech does not presently know or
that Alvotech currently believes are immaterial that could also
cause actual results to differ from those contained in the
forward-looking statements. Nothing in this communication should be
regarded as a representation by any person that the forward-looking
statements set forth herein will be achieved or that any of the
contemplated results of such forward-looking statements will be
achieved. You should not place undue reliance on forward-looking
statements, which speak only as of the date they are made. Alvotech
does not undertake any duty to update these forward-looking
statements or to inform the recipient of any matters of which any
of them becomes aware of which may affect any matter referred to in
this communication. Alvotech disclaims any and all liability for
any loss or damage (whether foreseeable or not) suffered or
incurred by any person or entity as a result of anything contained
or omitted from this communication and such liability is expressly
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otherwise hold Alvotech or any of its directors, officers,
employees, affiliates, agents, advisors, or representatives liable
in any respect for the provision of this communication, the
information contained in this communication, or the omission of any
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STADA information for
journalists:STADA Arzneimittel AG - Media
RelationsStadastrasse 2-1861118 Bad Vilbel - Germany Phone: +49 (0)
6101 603-165E-Mail: press@stada.de Or visit us on the Internet at
www.stada.com/press Follow @STADAGroup on LinkedIn
STADA information for capital market
participants:STADA Arzneimittel AG - Investor &
Creditor Relations Stadastrasse 2-1861118 Bad Vilbel –
GermanyPhone: +49 (0) 6101 603-4689Fax: +49 (0) 6101 603-215E-mail:
ir@stada.de Or visit us on the Internet at
www.stada.com/investor-relations
ALVOTECH Investor Relations and Global
CommunicationsBenedikt Stefansson,
VPalvotech.ir@alvotech.com
1 Uzpruvo® is currently not approved for the
ulcerative colitis indication, since the originator still has
exclusivity for this indication2 Union Register of medicinal
products - Public health - European Commission (europa.eu)
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