^* Due to the positive opinions of the Committee for Medicinal Products for Human Use
(CHMP), the European Commission has approved the biosimilars
PONLIMSI and DEGEVMA granted by Teva and thus access to important
Bone health treatments expanded across Europe
* These approvals represent another significant milestone in the strong
Teva’s biosimilar portfolio and are consistent with the
Company growth strategy
* The approvals underscore Teva’s commitment to increasing access
Expand biosimilars
TEL AVIV, Israel, Nov. 26, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceuticals
International GmbH, a subsidiary of Teva Pharmaceutical Industries
Ltd. (NYSE: and TASE: TEVA) announced that the European Commission
(EK) received market approval for its two denosumab biosimilar candidates –
PONLIMSI, a biosimilar to Prolia®(1), and DEGEVMA, a biosimilar to Xgeva® –
after the Committee for Medicinal Products for Human Use (CHMP) earlier this year
gave a positive opinion last year.
These approvals represent another significant milestone
Teva’s industry-leading biosimilar portfolio and its ongoing
Commitment to improving patient access to important biologics
therapies across Europe. Teva intends to launch both products in the coming years
months in the most important European markets.
The approval represents a significant step in the implementation of the
Teva’s growth strategy and underlines its commitment
Company to expand access to biosimilar medicines for patients.
Steffen Nock, SVP Head of Biosimilars & Chief Science Officer, said:?This
Approval represents a significant step forward in ensuring patient access
Facilitate biosimilar therapies for serious bone diseases. The
shows how important it is to us to provide better care for patients
support.”
Michal Nitka, SVP Head Generics Europe & Global Head OTC, added:?Through
With product launches like these, we remain committed to providing additional
Providing treatment options to healthcare systems across Europe –
particularly in countries where access to biosimilars is still improving
can be.”
About PONLIMSI
PONLIMSI (denosumab) is indicated for the treatment of osteoporosis
postmenopausal women and men with an increased risk of fractures, for treatment
of bone loss associated with hormone ablation in men
Prostate cancer, which have an increased risk of fractures, or for the treatment of
Bone loss in adults undergoing long-term treatment
undergo systemic glucocorticoids.
The active ingredient denosumab is a human monoclonal IgG2 antibody that works against
the protein RANKL is directed, which is responsible for the formation, function and survival
of osteoclasts – the cells responsible for bone breakdown –
is essential. By binding to RANKL with high affinity and specificity
Denosumab prevents the interaction between RANKL and RANK, resulting in a
Reduction of bone resorption in cortical and trabecular bone
leads.
PONLIMSI is available as a 60 mg/1 ml solution for injection in a pre-filled syringe
be.
PONLIMSI is a biosimilar medicine that is similar to the reference medicine Prolia®
(Denosumab), which was approved in the EU on May 26, 2010.
Comprehensive analytical, preclinical and clinical data demonstrate that PONLIMSI
in terms of quality, safety and effectiveness with the reference product
is comparable.
About DEGEVMA
DEGEVMA (denosumab) is used to prevent bone complications in adults
with advanced cancer that has affected the bones, as well as for treatment
of adults and skeletally mature adolescents with giant cell tumors
Bone indicated.
The active ingredient denosumab is a human monoclonal IgG2 antibody that works against
the protein RANKL is directed, which is responsible for the formation, function and survival
of osteoclasts – the cells responsible for bone breakdown –
is essential. By binding to RANKL with high affinity and specificity
Denosumab prevents the interaction between RANKL and RANK, resulting in a
Reduction of bone resorption in cortical and trabecular bone leads.
DEGEVMA is supplied as a 120 mg/1.7 ml solution for injection in a vial
be available.
DEGEVMA is a biosimilar medicine that is similar to the reference product Xgeva®
(Denosumab), which was approved in the EU on July 13, 2011, is similar.
Comprehensive analytical, preclinical and clinical data demonstrate that DEGEVMA
in terms of quality, safety and effectiveness with the reference product
is comparable.
About Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
innovative biopharmaceutical company with a world-class generics business
is supported. For over 120 years, Teva has been tirelessly committed to the
Improving health. Of innovations in the areas
neuroscience and immunology to global delivery
complex generics, biosimilars and pharmacy brands – Teva has made it its goal
The task is to meet the needs of patients today and in the future.
At Teva, we are all committed to better health: We Are All In For
Better health.
Further information can be found at www.tevapharm.com
(http://www.tevapharm.com/).
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements that are personal
Securities Litigation Reform Act of 1995, based on current assessments
and expectations of management and significant known and
are subject to unknown risks and uncertainties that may result in
our future results, performance or achievements may differ significantly from those in
results expressed or implied by such forward-looking statements
differ. You can identify these forward-looking statements by, among other things:
the use of words such as “should”, “expect”, “anticipate”, “estimate”,
“aim”,?could”,?predict”,?guideline”,?intend”,
“plan”, “believe” and other words and terms with similar meaning
and language related to discussions about the future
recognize operational or financial performance. Among the essential factors
Risks that could cause or contribute to such deviations include:
Regarding: our ability to use PONLIMSI (denosumab) for treatment and prevention
of osteoporosis in postmenopausal women and men with increased
to successfully develop and market fracture risk; our ability,
DEGEVMA (denosumab) for the prevention of bone complications in adults with
advanced cancer that has affected the bones and to treat
Adults and skeletally mature adolescents with giant cell tumors of the bones
to successfully develop and market; our ability to succeed
to compete in the market, including our ability to provide additional
to develop and market pharmaceutical products; our ability,
Successfully implement our growth strategy, including expansion
our pipeline of innovative and biosimilar medicines and the profitable ones
Marketing the portfolio of innovative medicines and biosimilars, be it
organically or through business development; as well as other factors that occur in
our Quarterly Report on Form 10-Q for the third quarter of 2025 and in
our Annual Report on Form 10-K for the period ended December 31, 2024
Fiscal year, including the sections entitled “Risk Factors” and
“Forward-Looking Statements.” Forward-Looking Statements
apply only at the time of publication and we are not obliged to do so
to forward-looking statements or other information contained herein
update or revise, whether as a result of new information,
future events or for other reasons. We hereby point this out to you
not to place undue reliance on these forward-looking statements
set.
Media inquiries to Teva
(mailto:[email protected])
Inquiries about investor relations at Teva
[email protected] (mailto:[email protected])
________________________
1 Prolia® and Xgeva® are registered trademarks of Amgen, Inc.
°
By the way: Teva Pharmaceutical Industries and other US stocks can even be traded on finanzen.net ZERO until 11 p.m. (without order fees, plus spreads). Open a depot now for free and secure a new customer bonus!