Samsung Bioepis won a lawsuit against Johnson & Johnson (J&J), the parent company of Janssen, the original developer of the autoimmune disease treatment Stelara.
According to the industry on the 30th, the U.S. District Court for New Jersey dismissed J&J’s motion for a preliminary injunction regarding Samsung Bioepis’s sale of the Stelara biosimilar Pyzchiva on the 28th.
If the preliminary injunction had been granted, Samsung Bioepis would have faced a crisis of being banned from selling Pyzchiva in the U.S. market, its main revenue source. Samsung Bioepis launched Pyzchiva, a treatment for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, on February 22 after reaching an agreement with J&J, the developer of the original autoimmune disease drug Stelara.
However, two days later, J&J filed a motion for a preliminary injunction, claiming that “Samsung Bioepis violated the contract and breached the implied duties of good faith and fair dealing.” They requested a sales ban regarding Samsung Bioepis granting private label authority to a pharmacy benefit manager (PBM), calling it “an unagreed matter,” but the New Jersey District Court dismissed the preliminary injunction application.
This court decision marks the first precedent for a case where an original drug company filed a preliminary injunction to block the PBM brand sales of a biosimilar developer, and with Samsung Bioepis winning, a green light has been signaled. Samsung Bioepis competes for the 1st to 2nd market share in the European Stelara biosimilar market with U.S. pharmaceutical company Amgen. Samsung Bioepis has selected Swiss pharmaceutical company Sandoz as its sales partner to target the U.S. Stelara biosimilar market.