Celltrion applies for approval in US for eye treatment biosimilar
Jeong Min Nam
Jun 30, 2023 (Gmt+09:00)
South Korean biopharmaceutical company Celltrion Inc. on Friday said it applied for approval from the US Food and Drug Administration (FDA) for CT-P42, a biosimilar of the eye treatment Eylea.
Based on the results of Phase 3 clinical trials worldwide of CT-P42, Celltrion applied with the FDA for approval of Eylea for all indications (excluding pediatric) like wet macular degeneration and diabetic macular edema (DME). After the US, the company will sequentially seek the green light in major economies such as those in Europe.
Celltrion confirmed CT-P42's equivalence to and similarity with Eylea in Phase 3 trials on 348 DME patients in 13 countries like the Czech Republic, Hungary, Poland and Spain.
Developed by Regeneron of the US, Eylea is a blockbuster drug with global sales last year of $9.7 billion. Its exclusive rights in the US expire in May next year and its patents in Europe in November 2025.
“We will do our best to expand our biosimilar portfolio to ophthalmology by sequentially applying for approval in major countries like those in Europe starting with the US,” a Celltrion source said.
The company will complete this year's applications for global approval for up to five biosimilars including CT-P42.