A protracted legal battle between Samsung Bioepis and Regeneron Pharmaceuticals over a biosimilar version of the eye drug Eylea has concluded with a settlement and license agreement, . This resolution follows a similar agreement with Celltrion Inc. And Formycon AG, leaving Amgen Inc. As the sole remaining defendant in Regeneron’s broader campaign to protect its blockbuster drug.
The dispute originated in late , when Regeneron filed a patent infringement complaint alleging that Samsung Bioepis’s development and submission of an abbreviated Biologics License Application (aBLA) for its Eylea biosimilar, OPUVIZ (aflibercept-yszy), violated 37 of its patents. Regeneron specifically claimed that Samsung imported 17 shipments of the biosimilar to the United States between and , in breach of patents covering manufacturing methods, formulations, and administration of aflibercept.
OPUVIZ received FDA approval in as one of the first two biosimilars to Eylea 2 mg (aflibercept) in the United States, approved for all indications except one. The case centered on the Biologics Price Competition and Innovation Act (BPCIA), which governs the expedited review process for biosimilars, and specifically, Regeneron’s allegations that Samsung’s actions violated the BPCIA’s provisions regarding patent protection.
Under the terms of the settlement, as outlined in a court order issued by Judge Thomas S. Kleeh in the US District Court for the Northern District of West Virginia, Samsung Bioepis and Regeneron have agreed to dismiss all claims, and counterclaims. The injunction that had previously barred Samsung Bioepis’s biosimilar has been lifted, and the payment held as a bond has been released. This effectively clears the way for Samsung Bioepis to commercially distribute OPUVIZ.
Samsung Bioepis is a wholly owned subsidiary of Samsung Biologics, a South Korean biopharmaceutical company specializing in biosimilar development across a range of therapeutic areas including ophthalmology, immunology, oncology, hematology, endocrinology, and gastroenterology. Biosimilars are designed to be highly similar to existing biologic drugs, offering a potentially more affordable alternative for patients. The development of biosimilars is a complex process, requiring extensive testing to demonstrate similarity in terms of safety, efficacy, and quality.
Regeneron’s aggressive defense of its Eylea franchise highlights the significant financial stakes involved in the biosimilar market. Eylea is a widely used treatment for several retinal conditions, including age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. The introduction of biosimilars poses a competitive threat to originator biologic drugs, potentially eroding market share and revenue.
The settlement with Samsung Bioepis represents a strategic move for Regeneron, allowing the company to focus its legal resources on the remaining case against Amgen. The outcome of that case will likely have further implications for the competitive landscape of the Eylea biosimilar market. The legal battles underscore the challenges inherent in navigating the BPCIA and protecting intellectual property rights in the rapidly evolving biopharmaceutical industry.
The case also has implications for the broader pharmaceutical industry, particularly concerning the interpretation and enforcement of patent laws related to biologic drugs. The BPCIA was designed to balance the need to incentivize innovation with the goal of increasing access to more affordable medications. The ongoing litigation surrounding Eylea biosimilars demonstrates the complexities of achieving this balance.
A separate, related legal proceeding took place in the High Court, as evidenced by an approved judgment from October , involving Formycon and Samsung against Regeneron and Bayer concerning aflibercept. Details of this judgment are limited in the available information, but it indicates a parallel legal front in the dispute.
The resolution of the Samsung Bioepis case, coupled with the ongoing litigation against Amgen, signals a continued period of legal maneuvering in the Eylea biosimilar space. The outcome of these cases will shape the future of competition in the market and influence the strategies of other companies developing biosimilar products. Biocon Biologics is also making advances with its Eylea biosimilars, further intensifying the competitive dynamics.
