Celltrion said it recently submitted a marketing authorization application for CT-P42, an Eylea (aflibercept) biosimilar, to the European Medicines Agency (EMA).

The application is for wet age-related macular degeneration (wAMD), cystoid retinal vein occlusive (CRVO-BRVO) macular edema, diabetic macular edema (DME), and choroidal neovascularization (CNV).

The anticipated timeframe for completing the marketing authorization is currently unknown.

The company stated that plans for selling CT-P42 in the EU market will be finalized after obtaining marketing authorization.

The application is based on phase 3 results of CT-P42, confirming the equivalence and similarity of CT-P42 to Eylea, which included 348 patients with diabetic macular edema in 13 countries, comprising the Czech Republic, Hungary, Poland, and Spain.

The original drug, Eylea, generated global sales of approximately $9.7 billion last year.

However, Eylea's U.S. exclusivity is set to expire in May next year and its patent in the E.U. is to expire in November 2025.

Based on the phase 3 results of CT-P42, Celltrion is preparing for global market entry by submitting marketing authorization applications in major countries such as the U.S., South Korea, and Europe.

The company said it will gradually strengthen its influence in the global market by expanding its product portfolio to various areas ranging from autoimmune diseases and anticancer therapies, where it has shown its existing strengths, to eye diseases, asthma and urticaria, and osteoporosis therapies.

In addition, the company will finalize the pending merger with Celltrion Healthcare by the end of the year and continue to develop new drugs and open innovation to achieve its target of 12 trillion won ($9.2 billion) in sales by 2030.