Regeneron Stock Down on Court Ruling for Amgen's Biosimilar of Eylea
Shares of Regeneron Pharmaceuticals, Inc. REGN were down 4.63% after an unfavorable ruling in its lawsuit against Amgen AMGN in the United States District Court for the Northern District of West Virginia.
The lawsuit was related to a biosimilar of its lead drug Eylea (aflibercept 2 mg).
Regeneron’s shares have rallied 24.3% year to date against the industry’s decline of 1.5%.
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REGN’s Lawsuit Against AMGN
Eylea, REGN’s lead drug, is approved for various retinal conditions such as neovascular age-related macular degeneration, macular edema and diabetic retinopathy.
In January 2024, REGN filed a patent infringement lawsuit against Amgen in the U.S. District Court for the Central District of California. The lawsuit alleged that Amgen's filing for FDA approval of a biosimilar of Eylea infringes certain REGN’s patents.
In April 2024, the U.S. Judicial Panel on Multidistrict Litigation granted Regeneron’s motion to transfer this lawsuit to the U.S. District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the ongoing lawsuits for additional Eylea biosimilars.
In June 2024, REGN filed a motion for a preliminary injunction against Amgen.
However, on Sept. 23, U.S. District Judge Thomas Kleeh rejected Regeneron's request for a preliminary injunction against Amgen.
Reportedly, REGN has appealed against the ruling.
As a result of this ruling, Amgen can launch its biosimilar amid the ongoing litigation. The FDA recently approved Amgen’s biosimilar of Eylea — Pavblu. This is the fifth biosimilar approved for Eylea.
REGN’s Growth Engine Eylea Faces Biosimilar Competition
The FDA had earlier approved Biocon Biologics's Yesafili (aflibercept-jbvf) and Samsung Bioepis' Opuviz (aflibercept-yszy) as Eylea’s biosimilars. Another FDA-approved biosimilar of Eylea is Ahzantive (aflibercept-mrbb).
Last month, the FDA also approved Sandoz biosimilar, Enzeevu, for the same.
Regeneron is involved in various lawsuits for these biosimilars.
Eylea sales came in at $5.7 billion in the United States in 2023. Sales continue to be under pressure in 2024 due to competition from Roche’s RHHBY Vabysmo.
Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The drug raked in sales of CHF 1.8 billion in the first half of 2024 on strong demand in all regions.
Roche has already obtained FDA approval for Vabysmo prefilled syringe for people living with wet age-related macular degeneration, DME and retinal vein occlusion.
To counter the decline in Eylea sales, Regeneron developed a higher dose of the drug. The initial uptake of Eylea HD is encouraging.
REGN has a collaboration with Bayer BAYRY for Eylea.
Regeneron maintains exclusive rights to Eylea and Eylea HD in the United States. Bayer has licensed exclusive marketing rights outside the United States, where the companies equally share the profits from the sales of Eylea 2 mg and Eylea 8 mg following any regulatory approval.
REGN’s Zacks Rank
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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