STADA and Alvotech launch Uzpruvo, the first approved ustekinumab
biosimilar to Stelara, across Europe
STADA and Alvotech launch Uzpruvo, the first approved
ustekinumab biosimilar to Stelara, across Europe
- Launch of European-made Uzpruvo in
Europe comes immediately upon expiry of exclusivity rights for the
molecule used to treat certain conditions in
gastroenterology1, dermatology and rheumatology
- Creates competition at earliest
opportunity, enabling straightforward switching to broaden patient
access and control costs in a growing market, with accessible
indications currently estimated at approximately €2.4 billion
- Ustekinumab is the second
immunology biosimilar brought to market through the partnership
between STADA and Alvotech, following the 2022 launch of the
Hukyndra high-concentration adalimumab brand
Bad Vilbel, Germany and Reykjavik, Iceland –
22 July 2024 –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 Alvotech
Alvotech 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.
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1 Uzpruvo® is currently not approved for
the ulcerative colitis indication, since the originator still has
exclusivity for this indication
2 Union Register of medicinal products - Public health -
European Commission (europa.eu)