Three biosimilars by Celltrion near EU approval following CHMP endorsement

Celltrion, a leading South Korean biopharmaceutical company, has received positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for three biosimilar candidates. This development is a significant step toward marketing authorisation approval in the European Union (EU), highlighting the company’s dedication to improving biosimilar treatment access in key therapeutic areas, including retinal disorders, autoimmune diseases, and skeletal-related conditions.

With the EMA’s backing, Celltrion’s biosimilar portfolio—comprising Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab), and Avtozma (tocilizumab)—could redefine treatment affordability and accessibility across Europe.

What Is a Biosimilar Candidate Approval, and Why Does It Matter?

Biosimilar candidate approval refers to regulatory validation of drugs developed to be highly similar to already authorised biological medicines, known as reference products. This process ensures that biosimilars deliver equivalent safety, efficacy, and quality, offering more affordable options to healthcare systems burdened by high treatment costs.

For Celltrion, the positive CHMP opinion for three distinct biosimilars signifies a pivotal moment in its mission to address unmet medical needs while fostering cost-effectiveness within European healthcare systems.

Eydenzelt: A Breakthrough in Retinal Disorder Biosimilars

Eydenzelt (CT-P42), a biosimilar to Bayer’s Eylea, has been recommended for approval to treat various retinal conditions, including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

Phase III clinical trial data for Eydenzelt revealed its equivalence to Eylea in terms of safety, efficacy, and immunogenicity, particularly for patients with diabetic macular edema. The approval of Eydenzelt could introduce one of the first-wave aflibercept biosimilars to Europe, a move that is expected to enhance biosimilar treatment access for retinal diseases while reducing the financial strain on healthcare systems.

How Will Stoboclo and Osenvelt Transform Osteoporosis Treatment?

Celltrion’s Stoboclo and Osenvelt, biosimilars referencing Amgen’s Prolia and Xgeva respectively, have been recommended for marketing authorisation to treat osteoporosis and prevent skeletal-related events in cancer patients.

Stoboclo targets osteoporosis in postmenopausal women, men at high fracture risk, and individuals experiencing bone loss due to prolonged corticosteroid use or hormone ablation therapy. Osenvelt, on the other hand, is designed for patients with advanced malignancies involving bone or inoperable giant cell tumours of the bone.

Clinical trial data demonstrated that both biosimilars matched their reference products in efficacy, pharmacodynamics, and safety. If approved, they will provide cost-effective alternatives for patients and help alleviate the economic burden on healthcare systems managing osteoporosis and cancer-related skeletal complications.

Avtozma: Meeting the Demand for Affordable Autoimmune Treatments

Avtozma (CT-P47), a biosimilar referencing Roche’s RoActemra (tocilizumab), is poised to meet the growing demand for accessible treatments for autoimmune diseases. Recommended for all indications of its reference product, Avtozma is intended to address conditions such as moderate to severe rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), and giant cell arteritis (GCA).

Clinical trials demonstrated Avtozma’s equivalence in safety and efficacy to RoActemra, with no clinically significant differences observed. If granted marketing authorisation approval, Avtozma will provide a more affordable option for patients in need of advanced therapies for autoimmune conditions.

Why Does Positive CHMP Opinion Matter for European Healthcare Systems?

Positive CHMP opinion serves as a critical endorsement for biosimilar candidates, paving the way for marketing authorisation approval by the European Commission. For Celltrion, this endorsement validates the company’s ability to develop high-quality biosimilars that align with stringent EU regulatory standards.

The availability of these biosimilars will not only improve biosimilar treatment access for patients across Europe but also empower healthcare providers with cost-effective tools to manage chronic and complex conditions.

What Sets Celltrion Apart in the Biosimilar Market?

Celltrion’s integrated approach to biosimilar development ensures supply chain stability and high manufacturing standards. With a diverse portfolio that includes biosimilars for oncology, autoimmune diseases, and infectious conditions, the company has consistently demonstrated its commitment to addressing unmet medical needs.

According to Taehun Ha, Vice President and Head of Europe at Celltrion, the company aims to transition from a pioneer in the biosimilar industry to a frontier leader, offering innovative solutions tailored to the unique challenges of European healthcare systems.

What Comes Next for Celltrion?

The CHMP’s recommendations for Eydenzelt, Stoboclo, Osenvelt, and Avtozma will now move to the European Commission for final approval. If granted marketing authorisation, these biosimilars will be available across EU member states, significantly enhancing access to high-quality treatments.

This milestone reflects Celltrion’s broader strategy to expand its footprint in the global biosimilar market while prioritising affordability and innovation.