Tuesday, June 18, 2024

Biosimilar Breakthrough: Celltrion’s Omlyclo ® (CT-P39) Receives European Commission Approval as First Omalizumab Biosimilar in Europe

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Biosimilar advancements in the treatment of allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria (CSU) have taken a significant step forward with the European Commission’s (EC) approval of Omlyclo ® (CT-P39). This marks the first time an omalizumab biosimilar has been approved in the European Union, providing new treatment options for patients.

The EC’s decision to approve Omlyclo ® is based on robust clinical evidence, including results from a global Phase III clinical trial. This trial demonstrated that Omlyclo ® has an efficacy and safety profile comparable to the reference product, Xolair ®. Specifically, the trial focused on patients with CSU and showed positive results through week 40.

Biosimilar Breakthrough: EMA Recommends and Approves Omlyclo ®, Expanding Access to Critical Treatments

This approval follows the marketing authorization recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024. The decision underscores the importance of biosimilars in expanding access to critical treatments.

Omlyclo ® is expected to address treatment access issues, providing a more affordable option compared to the original biologic. This is particularly important for patients with conditions like allergic asthma, CSU, and CRSwNP, where access to effective treatments can significantly impact quality of life.

Marcus Maurer, a professor of dermatology and allergology, highlighted the significance of this development, noting that the availability of a biosimilar to omalizumab is a welcome solution to treatment access challenges. He emphasized that Omlyclo ® has shown comparable efficacy, safety, and immunogenicity to Xolair ®, making it a viable alternative for patients.

The approval of Omlyclo ® reinforces Celltrion’s commitment to expanding its biosimilar portfolio in Europe. Hyoung-Ki Kim, Vice President of Celltrion, expressed enthusiasm for the approval, emphasizing its role in improving patient access to treatment for immunological diseases like asthma. This approval marks Celltrion’s sixth biosimilar drug, adding to its portfolio, which includes Remsima ® SC, Truxima ®, Herzuma ®, Yuflyma ®, and Vegzelma ®.

Biosimilar

Biosimilar Breakthrough: Omlyclo ® Under FDA Review, European Approval Sets Positive Precedent for Global Expansion

Omlyclo ® is currently under review by the US Food and Drug Administration (FDA), with a submission made in March 2024. The approval in Europe sets a positive precedent for future approvals in other regions.

Omlyclo ® is the first anti-IgE antibody biosimilar approved by the European Commission, referencing Xolair ® (omalizumab). In the EU, it is indicated for the treatment of patients with allergic asthma, CSU, and CRSwNP. The drug’s development and approval are significant milestones in providing broader access to effective treatments for these conditions.

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Celltrion, based in Incheon, South Korea, is a leading biopharmaceutical company focused on the research, development, manufacturing, marketing, and sales of innovative therapeutic products. The company’s solutions include world-class monoclonal antibody biosimilar medicines, such as Remsima ®, Truxima ®, and Herzuma ®, providing broader access to patients globally. Celltrion has also received FDA and CE approval in the United States for Vegzelma ® and Yuflyma ®, FDA approval for Zymfentra™, and CE approval for Remsima ® SC.

Celltrion’s forward-looking statements highlight the company’s optimism about the future of Omlyclo ® and its potential impact on patient care. The company acknowledges the inherent risks and uncertainties in developing and commercializing biosimilars but remains committed to providing innovative and accessible treatment options.

As biosimilars continue to gain acceptance and regulatory approval, they are poised to play a crucial role in expanding access to affordable healthcare solutions. The approval of Omlyclo ® is a significant step in this direction, offering hope for better management of allergic asthma, CSU, and CRSwNP.

The introduction of Omlyclo ® into the European market not only strengthens Celltrion’s position as a leader in biopharmaceutical innovation but also sets a new standard for biosimilar approvals. The company’s ongoing efforts to develop and commercialize biosimilars will likely continue to make a meaningful difference in the lives of patients worldwide.

Resource:  Businesswire, May 28, 2024

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