Samsung Bioepis has successfully defeated Janssen Biotech’s appeal in the Hague Court of Appeal in which Janssen sought to overturn an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates (SPC) by manufacturing and stockpiling Samsung Bioepis’ ustekinumab biosimilar, Pyzchiva®, for export outside the European Union.
The Hague Court of Appeal confirmed that the SPC Regulation’s manufacture-for-export exemption did not require trade licences at the time of notification nor that the export countries be duty-free. The Hague Court of Appeal therefore held that stockpiling for export was permissible under the exemption, facilitating a “Day-1 entry” – for generic and biosimilar medicines after the SPC expires – into the market of the intended export country.
Pyzchiva® was developed by Samsung Bioepis, and was approved in Europe in April 2024. It is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis. Sandoz launched Pzychiva® in Europe in July 2024, for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis. Although Pyzchiva® was not the first approved ustekinumab biosimilar product in Europe (it followed approval of Alvotech/Stada’s Uzpruvo® in January 2024 and announcement of its launch on 22 July 2024), it was the first ustekinumab biosimilar to be available in all reference medicine strengths.