EMA CHMP Issues Positive Opinion for Aflibercept Biosimilar from Celltrion

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and marketing authorization recommendation for Eydenzelt, Celltrion’s biosimilar to aflibercept (Eylea). This marks a significant milestone for Celltrion, a South Korea-based biopharmaceutical company, as it continues to expand its footprint in the European healthcare market.

About Eydenzelt (Biosimilar Aflibercept)

Previously known as CT-P42, Eydenzelt is a 40 mg/mL solution for injection available in both vial and prefilled syringe formats. The biosimilar is recommended for the treatment of several retinal disorders:

       • Neovascular (wet) age-related macular degeneration (AMD)

       • Diabetic macular edema (DME)

       • Macular edema following retinal vein occlusion (branch or central RVO)

       • Myopic choroidal neovascularization (myopic CNV)

Clinical Evidence

A Phase III clinical trial demonstrated Eydenzelt’s:

       • Efficacy

       • Safety

       • Pharmacokinetics

       • Immunogenicity

The study confirmed that Eydenzelt met the predefined equivalence criteria when compared to the reference product aflibercept in patients with DME.

Other Positive Opinions for Celltrion Biosimilars

In addition to Eydenzelt, the CHMP issued positive opinions for two other Celltrion biosimilars:

       • Stoboclo and Osenvelt: Biosimilars of denosumab, used to treat osteoporosis and hypercalcemia.

       • Avtozma: A biosimilar of tocilizumab, used to treat moderate to severe rheumatoid arthritis.

The European Commission (EC) will now decide on granting marketing authorization for these biosimilars, including Eydenzelt.

Celltrion’s Commitment to European Healthcare

Taehun Ha, Vice President of Celltrion and Head of the European Business Unit, emphasized the importance of these approvals:

“These approvals underscore our commitment to supporting European healthcare systems by improving access to high-quality, affordable treatments. Our focus remains on empowering clinicians with the tools and solutions they need, as we aim to transition from a pioneer to a frontier leader in European healthcare.”

Conclusion

The positive CHMP opinion for Eydenzelt reflects the growing momentum in the development of biosimilars for retinal disorders. If approved by the European Commission, Eydenzelt could provide patients and clinicians with a more accessible and cost-effective treatment option for sight-threatening retinal conditions.

Celltrion’s advancements highlight its dedication to enhancing global access to affordable, high-quality biologics, reinforcing its role as a leader in the biosimilar market.