Celltrion Wins First Trial in US Patent Lawsuit Over Aylia Biosimilar

'CT-P42' Indications
"Expecting Smooth Entry into the US Market"

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 18th that it won the first trial in two patent invalidation lawsuits against Regeneron in the United States.

This lawsuit concerns the U.S. patent related to the treatment of neovascular eye diseases for the original drug Eylea (active ingredient Aflibercept), which is related to Celltrion's ophthalmic disease treatment drug under development, 'CT-P42.' Last May, Mylan filed a U.S. patent invalidation lawsuit (IPR) against Regeneron, and Celltrion jointly participated by applying to join the lawsuit in December last year. The first trial result came out 11 months after joining the lawsuit.

The expiration dates of the two patents won in the first trial are January and May 2032, respectively. If Celltrion and other joint plaintiffs ultimately win the U.S. patent invalidation lawsuit, stable entry of CT-P42 into the U.S. market after development completion will be possible. In September last year, Celltrion also proactively filed an invalidation lawsuit against one patent related to the Eylea formulation, and in March this year, Regeneron, the patent holder, declared final patent abandonment, leading to a victory in the invalidation lawsuit.

In April, Celltrion completed global Phase 3 clinical patient recruitment for CT-P42 and is conducting comparative studies on efficacy, safety, pharmacokinetics, and immunogenicity with the original drug in patients with diabetic macular edema (DME) in a total of 13 countries, including Germany and Spain.

A Celltrion official said, "Through this first trial victory in the U.S. patent invalidation case, smooth entry of CT-P42 into the U.S. market is expected," adding, "We will focus on product development to provide high-quality biopharmaceuticals at reasonable prices to patients with ophthalmic diseases in the U.S. and do our best to prepare for the U.S. market entry process."

This content was produced with the assistance of AI translation services.