Celltrion Inc. has launched a global Phase 3 clinical trial of CT-P42, an investigational biosimilar candidate referencing Regeneron’s Eylea (aflibercept), the Korean company announced on Sunday.
The trial will be conducted in patients with diabetic macular edema (DME) in 13 countries by the second half of 2022 to compare the biosimilar and its original product in terms of efficacy, safety, pharmacokinetics and immunogenicity.
Eylea is a global blockbuster indicated for the treatment of patients with age-related macular degeneration and DME, and its 2019 worldwide sales amounted to 8.5 trillion won ($7.58 billion).
Celltrion started research of CT-P42, considering the original drug will go off patent in the U.S. in Nov. 2023.
Celltrion expects CT-P42 to significantly fatten its bottom line as a new growth driver alongside other investigational biosimilars including CT-P17 (Humira biosimilar), CT-P16 (Avastin), CT-P39 (Xolaire), CT-P41 (Prolia), CT-P43 (Stelara) in the pipeline.
The company aims to receive regulatory approval for at least one product every year until 2030.
Celltrion shares closed 1.61 percent down at 336,000 won ($300.11), nearly unmoved by the news on Monday.