Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe
May 23 2024 - 9:26PM
Business Wire
- Omlyclo® (CT-P39), used to treat allergic asthma, chronic
rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous
urticaria (CSU), becomes the first omalizumab biosimilar approved
in the European Union
- The European Commission (EC) decision is based on clinical
evidence, including results from a Phase III clinical trial
demonstrating a comparable efficacy and safety profile with the
reference product Xolair®
- Omlyclo® is the first omalizumab biosimilar in allergic
diseases approved by the EC; the approval further bolsters the
expansion of Celltrion’s biosimilar portfolio in Europe
Celltrion today announced that the European Commission (EC) has
approved Omlyclo® (CT-P39), an omalizumab biosimilar referencing
Xolair®. Omlyclo® is approved for the treatment of allergic asthma,
chronic spontaneous urticaria (CSU), and chronic rhinosinusitis
with nasal polyps (CRSwNP).
The EC approval of Omlyclo® follows the recommendation for
marketing authorisation issued by the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) in March 2024.
The decision is based on clinical evidence, including results
from a global Phase III clinical trial designed to evaluate the
efficacy, safety and pharmacokinetics of Omlyclo® compared to the
reference product Xolair® in patients with CSU up to Week 40.
“For more than two decades, omalizumab, a blockbuster monoclonal
antibody anti-IgE, has revolutionised the management of chronic
immune-mediated inflammatory diseases,” said Professor Marcus
Maurer, Professor of Dermatology and Allergy, Co-Director for the
Fraunhofer Site for Immunology and Allergology of the Fraunhofer
Translational Medicine and Pharmacology ITMP and Executive Director
for the Institute of Allergology, Charité - Universitätsmedizin
Berlin, Germany. “The development of a biosimilar of omalizumab is
a welcome solution to help alleviate some challenges with treatment
access. The recently approved treatment Omlyclo® has a comparable
efficacy, safety and immunogenicity profile to Xolair®.”
“Immunological conditions such as asthma can have a significant
impact on the day-to-day lives of patients without appropriate
treatment and care. This is why we are pleased to receive the first
EC approval for an omalizumab biosimilar in Europe, an important
step towards improving patient access to treatment. As we continue
to expand our biosimilar offerings across the globe, building on
our immunology and oncology product portfolio, we look forward to
making a meaningful difference for patients living with
immunological conditions,” said Hyoung-Ki Kim, Vice Chairman at
Celltrion.
Omlyclo® is Celltrion’s sixth biosimilar, besides Remsima® SC, a
subcutaneous formulation of infliximab, approved for use in the EU,
following the approval of Remsima® (biosimilar infliximab),
Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab),
Yuflyma® (biosimilar adalimumab), and Vegzelma® (biosimilar
bevacizumab). Omlyclo® is currently under review by the U.S. Food
and Drug Administration (FDA), following the submission in March
2024.
About OMLYCLO® (CT-P39, biosimilar omalizumab)
Omlyclo® is the first European Commission (EC) approved anti-IgE
antibody biosimilar referencing Xolair® (omalizumab). In the
EU, Omlyclo® is indicated for the treatment of patients with
allergic asthma, chronic spontaneous urticaria (CSU) and chronic
rhinosinusitis with nasal polyps (CRSwNP).
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®
and Yuflyma®, FDA approval for Zymfentra™, and EC approval for
Remsima® SC. To learn more, please visit
www.celltrion.com/en-us.
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Trademark
Xolair® is a registered trademark of Novartis AG.
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