European Commission approves Celltrion’s SteQeyma® (CT-P43), a biosimilar to Stelara® (ustekinumab), for the treatment of multiple chronic inflammatory diseases
August 25 2024 - 5:57PM
Business Wire
- SteQeyma® (CT-P43) is approved as a biologic therapy in
gastroenterology, dermatology and rheumatology indications1
- The European Commission (EC) approval is based on the totality
of evidence including the results from a Phase III study in adults
with moderate to severe plaque psoriasis
- Celltrion is committed to expanding their biosimilar portfolio
and building expertise in immunology
Celltrion today announced that the European Commission (EC) has
approved the use of SteQeyma® (CT-P43), an ustekinumab biosimilar
referencing Stelara®, for the treatment of multiple chronic
inflammatory diseases. SteQeyma is approved as a biologic therapy
in gastroenterology, dermatology and rheumatology indications.1
Stelara was the first biologic therapy for Crohn’s disease to
target interleukin (IL)-12 and IL-23 cytokines, known to play a key
role in inflammatory and immune responses.2
The decision from the EC follows a positive opinion recommending
SteQeyma from the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) in June 2024.3
The EC approval of SteQeyma was based on the totality of
evidence, including the results from a Phase III study in adults
with moderate to severe plaque psoriasis, in which the primary
endpoint was the rate of change in the Psoriasis Area and Severity
Index (PASI) for skin symptoms. The clinical results demonstrated
that SteQeyma is highly similar to its reference product, Stelara,
and has no clinically meaningful differences in terms of efficacy
and safety.4,5
“The EC approval of SteQeyma brings an important new therapeutic
option to patients and we’re excited to launch this innovative
therapy, with a proven track record in Crohn’s and other immune
diseases,” said Taehun Ha, Senior Vice President and Head of Europe
Division at Celltrion. “This approval, alongside those of Remsima
SC and Yuflyma, marks a key milestone in our strategy to strengthen
Celltrion’s immunology offering, and with the recent approval of
Omlyclo in May, we are looking forward to expanding our portfolio
into the dermatology sector. We believe the approval demonstrates
our unwavering commitment to expanding patient access to
affordable, high-quality biologic medicines.”
SteQeyma is Celltrion’s seventh biosimilar approved for use in
the European Union (EU). Alongside Remsima® SC, a subcutaneous
formulation of infliximab approved in the EU, SteQeyma joins
Celltrion’s distinguished portfolio that includes Remsima®
(biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma®
(biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab),
Vegzelma® (biosimilar bevacizumab) and Omlyclo® (biosimilar
omalizumab).
About SteQeyma® (CT-P43, biosimilar ustekinumab)1
SteQeyma®, formerly known as CT-P43, is a human IL-12 and IL-23
antagonist indicated for multiple immune-mediated diseases.
SteQeyma is available in both subcutaneous and intravenous
formulations. The subcutaneous injection comes in two strengths:
45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled
syringe. The intravenous infusion is provided as a 130mg/26 mL
(5mg/mL) solution in a single-dose vial.
About Celltrion
Celltrion is a leading biopharmaceutical company based in
Incheon, South Korea that specialises in researching, developing,
manufacturing, marketing and sales of innovative therapeutics that
improve people's lives worldwide. The company’s solutions include
world-class monoclonal antibody biosimilars such as Remsima®,
Truxima® and Herzuma®, providing broader patient access globally.
Celltrion has also received U.S. FDA and EC approval for Vegzelma®,
Yuflyma® and Omlyclo®, FDA approval for Zymfentra®, and EC approval
for Remsima® SC. To learn more, please visit
www.celltrion.com/en-us.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains
statements related to our future business and financial performance
and future events or developments involving Celltrion Inc. and its
subsidiaries that may constitute forward-looking statements, under
pertinent securities laws.
These statements may be identified by words such as “prepares”,
“hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”,
“is preparing, “once gained”, “could”, “with the aim of”, “may”,
“once identified”, “will”, “working towards”, “is due”, “become
available”, “has potential to”, the negative of these words or such
other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking
statements. Such statements are based on the current expectations
and certain assumptions of Celltrion Inc. and its subsidiaries'
management, of which many are beyond its control.
Forward-looking statements are provided to allow potential
investors the opportunity to understand management’s beliefs and
opinions in respect of the future so that they may use such beliefs
and opinions as one factor in evaluating an investment. These
statements are not guarantees of future performance and undue
reliance should not be placed on them.
Such forward-looking statements necessarily involve known and
unknown risks and uncertainties, which may cause actual performance
and financial results in future periods to differ materially from
any projections of future performance or result expressed or
implied by such forward-looking statements.
Although forward-looking statements contained in this
presentation are based upon what management of Celltrion Inc. and
its subsidiaries believes are reasonable assumptions, there can be
no assurance that forward-looking statements will prove to be
accurate, as actual results and future events could differ
materially from those anticipated in such statements. Celltrion
Inc. and its subsidiaries undertake no obligation to update
forward-looking statements if circumstances or management’s
estimates or opinions should change except as required by
applicable securities laws. The reader is cautioned not to place
undue reliance on forward-looking statements.
Trademark
Stelara® is a registered trademark of Johnson & Johnson.
SteQeyma® is a registered trademark of Celltrion, Inc., used under
license.
References
1 European Medicines Agency Summary of Product Characteristics
(SmPC), SteQeyma. 2 European Medicines Agency. Summary of Product
Characteristics (SmPC), STELARA Available at:
https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf.
[Last accessed August 2024]. 3 European Medicines Agency. Meeting
highlights from the Committee for Medicinal Products for Human Use
(CHMP) 24-27 June 2024. Available at:
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024.
[Last accessed August 2024]. 4 Papp KA et al., Efficacy and Safety
of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in
Moderate to Severe Plaque Psoriasis: 28-Week Results of a
Randomised, Active-Controlled, Double-Blind, Phase III study.
BioDrugs. 2023; Available at:
https://link.springer.com/article/10.1007/s40259-023-00630-5. [Last
accessed August 2024]. 5 Papp K et al., Efficacy and Safety after
Switch from Reference Ustekinumab to Ustekinumab Biosimilar
(CT-P43) in comparison with the Maintenance Group (CT-P43 or
Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque
Psoriasis: 1-Year Result. [EADV 2023, Abstract #4035]. Available
at:
https://eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Biologics-immunotherapy-targeted-therapy.pdf.
[Last accessed August 2024].
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