Celltrion said it has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for CT-P42, a biosimilar referencing Eylea (ingredient: aflibercept) for the treatment of ocular diseases.

Based on the global phase 3 results of CT-P42, Celltrion has applied for marketing authorization for all of Eylea's indications, except for pediatric indications such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

In addition to the U.S., the company plans to file for approval of CT-P42 in other key global markets, including Europe.

Celltrion confirmed equivalence and similarity to the Eylea in a phase 3 clinical trial involving 348 patients with diabetic macular edema in 13 countries, including the Czech Republic, Hungary, Poland, and Spain.

"We have confirmed the equivalence and similarity of CT-P42 to Eylea in phase 3 clinical trials and completed the application for marketing authorization with the U.S. FDA," a Celltrion official said. "We will continue to apply for marketing authorization in major countries such as the U.S. and Europe and do our best to expand our biosimilar portfolio in the field of ophthalmic diseases."

Celltrion plans to complete global license applications for up to five biosimilars, including CT-P42, within the year, she added.

Eylea, developed by Regeneron Pharmaceuticals, is a blockbuster ophthalmic treatment that generated global sales of about $9.7 billion last year.

The drug's exclusivity expires in the U.S. in May 2024, and its European substance patent in November 2025.