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 * Home
 * Breaking News
 * Regeneron Files Lawsuit Against Celltrion Over Biosimilar Version of Eylea


REGENERON FILES LAWSUIT AGAINST CELLTRION OVER BIOSIMILAR VERSION OF EYLEA

November 13, 2023

Regeneron Pharmaceuticals Inc. has taken legal action against Celltrion Inc.,
filing a lawsuit to prevent the production and marketing of Celltrion's proposed
biosimilar version of Eylea®. Eylea, a crucial retinal disease treatment,
accounted for over half of Regeneron's revenue in 2022.

The legal complaint, lodged in the US District Court for the Northern District
of West Virginia, alleges that Celltrion's biosimilar, known as CT-P42,
infringes on 38 patents owned by Regeneron for Eylea. The lawsuit follows
Celltrion's announcement on June 30, revealing the submission of an abbreviated
Biologics Drug Application to the US FDA for CT-P42.



Regeneron contends that Celltrion's intention to launch CT-P42 immediately upon
FDA approval poses a direct threat to their patented technology.

Celltrion had earlier announced the results of its Phase III trials for CT-P42
on April 3, 2023, demonstrating its equivalence and similarity to Eylea.
However, Regeneron contends that the biosimilar violates its intellectual
property rights.

This legal battle is not the first involving Eylea. In November 2022, Celltrion
won a trial against Regeneron in a U.S. patent lawsuit related to Eylea. The
current lawsuit further underscores the complexity and competitiveness within
the biopharmaceutical industry, particularly in the realm of biosimilars.

About EYLEA®

EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is a prescription medicine
approved for the treatment of patients with Wet Age-related Macular Degeneration
(AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular
Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP).

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