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.
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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