Defendant
1 case as defendant.
Samsung Bioepis Co., Ltd. is a South Korean biopharmaceutical company headquartered in Incheon, South Korea, founded in 2012. Initially established as a joint venture with Biogen, Samsung Biologics acquired full ownership in 2022. In November 2025, Samsung Bioepis was spun off from Samsung Biologics and became a wholly owned subsidiary of the newly formed Samsung Epis Holdings. The company has approximately 1,000 to 1,274 employees as of late 2025/early 2026. In 2025, Samsung Bioepis recorded consolidated sales of 1.672 trillion Korean won (approximately $1.07 billion USD at 2024 sales conversion) and achieved 454.9 billion won in Q1 2026 revenue (approximately $307.1 million USD).
Samsung Bioepis operates as a developer of biopharmaceutical and biosimilar medicines, focusing on increasing patient access to high-quality, cost-effective treatments. Their portfolio includes biosimilars for immunology, oncology, ophthalmology, endocrinology, hematology, nephrology, and neurology, with specific products such as Etanercept, Infliximab, Adalimumab, Trastuzumab, Bevacizumab, Ranibizumab, Eculizumab, Aflibercept, Denosumab, and Ustekinumab biosimilars. The company also engages in new drug development, including antibody-drug conjugates (ADCs), and commercializes its products globally through partnerships with major pharmaceutical companies.
In terms of patent litigation, Samsung Bioepis is primarily a defendant, with one tracked case. This posture indicates that it is an operating company defending against patent infringement claims, which is typical for biosimilar developers challenging originator patents. The sole tracked case, Regeneron Pharmaceuticals, Inc. v. Samsung Bioepis Co., Ltd., involves a dispute over Samsung Bioepis's proposed biosimilar (SB15) of Regeneron's EYLEA (aflibercept).
The case against Samsung Bioepis was filed in the U.S. District Court for the Northern District of West Virginia. This BPCIA (Biologics Price Competition and Innovation Act) lawsuit alleged infringement of numerous patents related to EYLEA. A preliminary injunction was issued against Samsung Bioepis in June 2024. However, the parties filed a joint stipulation in February 2026 to dismiss all claims and counterclaims without prejudice, indicating a settlement.
Regeneron sued Samsung Bioepis for infringement of US Patent 11084865. The district court granted a preliminary injunction, which the Federal Circuit affirmed. A related IPR challenge (IPR2025-00176) at the PTAB was denied institution.