Pharmaceutical titan Regeneron has filed a weighty lawsuit against Samsung Bioepis Co., Ltd. The action, which took place in the U.S. District Court for the Northern District of West Virginia, targets an application for a biosimilar drug to Regeneron’s medication EYLEA.
According to the legal documents submitted by JD Supra, Samsung Bioepis is accused of infringing upon 37 patents under the Biologics Price Competition and Innovation Act (BPCIA). These infringement allegations relate to Bioepis’s submission of an abbreviated Biologics License Application (aBLA) for its proposed SB15 product, a Biosimilar of EYLEA (aflibercept).
EYLEA, a drug efficacious in conditions of the eye such as wet age-related macular degradation (AMD), macular edema following retinal vein occlusion, and diabetic macular edema, has been a potent revenue source for Regeneron. The proposed biosimilar from Bioepis threatens to cut into this profitability.
Adding another layer to this legal maelstrom is the allegation from Regeneron that Bioepis has violated laws by commencing Notice of Commercial Marketing for the allegedly infringing biosimilar. Bioepis’s premature marketing is a significant part of the case, suggesting that the company presumed approval for its product and began making commercial inroads before legal entanglements could constrain their movements.
The outcome of the lawsuit may have relevant implications for other biosimilar developers’ tactical maneuvers, as they face the balance between FDA approval processes, IP protections of innovator biologics, and gaining rapid market entry.