A lawsuit filed by Regeneron Pharmaceuticals Inc. is targeting Celltrion Inc. for its proposed production and marketing of a biosimilar version of Eylea (aflibercept).
Lots to unpack here … let’s start with Celltrion.
Based in South Korea—with U.S. headquarters established in 2018 in New Jersey—Celltrion is a biopharmaceutical company with a focus on small-molecule pharmaceuticals.
The company previously launched the first antibody biosimilar from a country with a “relatively underdeveloped pharmaceutical” industry, according to Celltrion.
More recently, in October 2023, Celltrion announced it would merge with Celltrion Healthcare Co. Ltd. by the end of 2023 (and Celltrion Pharm Inc. six months after).
Developed by Regeneron and Bayer AG, Eylea is a vascular endothelial growth factor (VEGF) inhibitor administered as an intravitreal injection.
The molecule was designed to inhibit new blood vessel growth and reduce vascular permeability in the eye by blocking major growth factors involved in ocular angiogenesis (VEGF-A and placental growth factor).
The formulation can be administered as an intravitreal injection 6-8 times a year. For infants with retinopathy of prematurity (ROP), treatment might require extended periods of monitoring.
And its clinical status?
Eylea was most recently approved by the FDA (in February 2023) for ROP treatment in preterm infants.
Prior to that, it was approved for the following retinal diseases:
- Wet age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR)
Gotcha. So what exactly is a biosimilar?
By definition, a biosimilar is essentially a biologic that is highly similar to—and contains no clinically meaningful difference from—an existing biologic medicine or product that has already been granted approval by the FDA.
Per the agency, biosimilars are intended to be safe and effective treatment options available for patients at a lower cost with increased access.
Now … let’s discuss this lawsuit.
Filed in the U.S. District Court for the Northern District of West Virginia, the complaint alleges that a biosimilar developed by Celltrion (CT-P42), would be an infringement on 38 Regeneron-owned patents for Eylea.
See the full lawsuit here.
Backup a moment … explain CT-P42.
CT-P42 is a biosimilar formulated by Celltrion to reference aflibercept (Eylea) for DME.
Back in June 2023, the company filed for FDA approval—via an abbreviated Biologics Drug Application (aBLA)—based on positive data from a global phase 3 clinical trial (NCT04739306) that compared CT-P42 to Eylea in 348 DME patients from 13 countries for 52 weeks.
To note, that data indicated CT-P42 demonstrated equivalence and similarity to Eylea.
And Regeneron’s basis?
Per the complaint, the company states that Celltrion’s plans for an imminent launch of CT-P42 (pending FDA approval, according to its commercial marketing plans) would pose a direct threat to its patented technology.
Yikes. But this isn’t the first Eylea lawsuit between these companies, right?
Nope. In fact, the companies duked it out in November 2022 over Eylea, where Celltrion won a U.S. patent lawsuit trial against Regeneron.
And didn’t Regeneron recently win a lawsuit of its own?
Yup. In January 2023, the company won a patent case against Novartis AG, in which the U.S. court ruled in favor of protecting its Eylea drug delivery system.
Brief background on that:Novartis filed a complaint in 2020 to the U.S. International Trade Commission that some of Regeneron’s pre-filled intravitreal injectable syringes— and Eylea delivery system—were in violation of its patent for Lucentis (ranibizumab). Regeneron then submitted a request for reconsideration of Novartis’s claims in 2021.
See our full Glance coverage here.
So how significant is Eylea to Regeneron’s profits?
Pretty significant, I’d say. The company generated over $1.6 billion in revenue (per its Q3 2022 financial report) in 2022—over half of its total 2022 revenue.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.