Allegedly, Samsung Bioepis signed a contract with a third-party health firm that granted it permission to commercialize a Stelara biosimilar under its own private label.
Johnson & Johnson filed a lawsuit against Samsung Bioepis, saying that the South Korean business had illegally allowed a third-party healthcare company to sell a “private label biosimilar” to Stelara, which is J&J’s therapy for Crohn’s disease that targets IL23.
The suit, which was submitted to the U.S. District Court of New Jersey and is largely redacted, asserts that Samsung Bioepis appeared to permit a third firm (not named) to sell its private-label product. In doing so, Samsung Bioepis is stated to be in “clear breach” of the agreement that it had with Janssen, which is a subsidiary of Johnson & Johnson.
As part of a settlement agreement that was made in November 2023 between Samsung Bioepis and Janssen, the Stelara clone will be allowed to enter the United States by February 22, 2025. Monday marked the debut of the biosimilar, which was given the name Pyzchiva.
While refraining from identifying the third-party provider, J&J did disclose in its lawsuit that it is an entity of a vertically integrated health corporation that comprises one of the major insurers and providers in the country. In addition, the conglomerate includes a pharmacy benefit manager and one of the largest drugstore chains in the nation as part of its group.
According to the pharmaceutical company, the arrangement that Samsung Bioepis had with this conglomerate was a covert and intentional violation of the contract. This breach threatens to cause irreparable injury to Johnson & Johnson, including a major reduction in Stelara’s market share. According to the lawsuit, if Samsung Bioepis’s action is permitted to proceed, it might also pose a threat to the capacity of Stelara and other biosimilars to compete in an equitable manner.
As per the complaint, Janssen wasn’t secretive with Samsung about the way it conducted its business unlawfully, even saying that the Korean firm didn’t even attempt justifying its actions. Johnson & Johnson is pursuing both a preliminary and permanent injunction against the agreement between Samsung and its outside partner, in addition to seeking compensatory damages.
The action comes as J&J faces an increasing influx of Stelara biosimilars in the U.S. market, posing a risk to the drug’s market supremacy.
Biocon Biologics introduced its Stelara biosimilar, Yesintek, concurrently with Samsung’s Pyzchiva. Leading the way is Amgen, whose Wezlana was introduced last month and has an FDA interchangeability classification, which allows it to be used in place of the reference medicine without requiring a prescription modification.
