Samsung Bioepis has secured another legal victory in the Netherlands over its Stelara (ustekinumab) biosimilar, Pyzchiva, easing concerns around its European expansion. On April 8 (local time), the Court of Appeal in The Hague dismissed an injunction filed by U.S. pharmaceutical company Janssen, which sought to block the sale of Pyzchiva.
The court rejected Janssen’s claim that Samsung Bioepis infringed on its Supplementary Protection Certificate (SPC), which extends patent rights to compensate for delays in regulatory approval. The ruling confirmed that Samsung Bioepis did not violate SPC terms by manufacturing Pyzchiva for export to countries where the SPC doesn’t apply, such as the UK and Canada.
This marks the second consecutive legal win for the company in Europe, following a UK High Court ruling last August that invalidated Janssen’s patent.
Samsung Bioepis is a South Korean biopharmaceutical company specializing in biosimilars. Established as a joint venture between Samsung Biologics and Biogen, the company has been expanding globally with cost-effective alternatives to high-priced biologic therapies.
After launching Pyzchiva in July 2023, Samsung Bioepis began aggressively targeting the European market. Backed by its regional distribution partner, Swiss pharmaceutical company Sandoz, Pyzchiva claimed a 43% share of the European Stelara biosimilar market as of January 2025, making it the leading product in its category.
With court wins in both the UK and the Netherlands, Samsung Bioepis is now expected to further solidify its position in Europe, reducing legal uncertainties and gaining competitive momentum.
