Samsung Bioepis has won an injunction filed by global pharmaceutical company Johnson & Johnson (J&J) in February, in which J&J alleged a breach of contract related to biosimilars.
According to industry sources on April 30, Samsung Bioepis entered into a settlement and license agreement with Janssen, the developer of Stelara, allowing the company to sell Pyzchiva in the U.S. market starting February 22. Two days later, on February 24, J&J and its subsidiary Janssen filed for an injunction with the U.S. District Court in New Jersey, claiming that Samsung Bioepis had breached the contract and violated the implied covenant of good faith and fair dealing.
J&J argued that Samsung Bioepis granting prescription benefit managers (PBMs) the right to sell private label products was not part of the original agreement, and that previous contracts did not grant the right to approve private label products. Private label refers to a practice where a biotech company does not sell its own biosimilar directly, but instead sells it under a different name through a third party.
On April 28, the U.S. District Court in New Jersey dismissed J&J’s request for an injunction. J&J had claimed that Samsung Bioepis’s private label agreement was a separate commercial partnership not agreed upon with J&J, and that it could cause significant harm to the company. However, this argument was not accepted. The specific details of the ruling were not disclosed in order to protect the confidentiality of the companies involved.
This ruling marks the first case in which an original drug manufacturer sought an injunction to block a biosimilar developer from selling private label products. It is considered a significant precedent, as the court sided with the biosimilar developer. Samsung Bioepis has continued to sell Pyzchiva in the U.S. market since February, regardless of the injunction proceedings.
With the dismissal of the injunction request, Samsung Bioepis is now able to launch Pyzchiva private label products in the U.S. market. As a result, the company is expected to increase both its market share and revenue.
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