UPDATE : Friday, May 29, 2020
Samsung, Genentech settle patent dispute on Herceptin biosimilar
  • By Lee Han-soo
  • Published 2019.07.05 11:47
  • Updated 2019.07.05 11:47
  • comments 0

Samsung Bioepis has settled a patent infringement case with Genentech, a subsidiary of Roche, regarding Ontruzant, its trastuzumab biosimilar (Original: Herceptin) to treat breast cancer, and signed a licensing agreement.

Samsung Bioepis headquarters in Songdo, Incheon.

The agreement will allow Samsung Bioepis to distribute, market, and sell the biosimilar Ontruzant in the United States. The company did not disclose the details of the settlement or when they will start marketing the drug, due to a confidentiality clause.

The settlement between the two companies came after Samsung received U.S. Food and Drug Administration approval for Ontruzant in January.

Although the Korean company received approval and major patents for Herceptin in the U.S. expired last month, Samsung was unable to launch its product as Genentech had been barring the launch of Herceptin biosimilars by partnering with biosimilar developers or bringing up patent disputes.

Through this agreement, Samsung has managed to clear uncertainties regarding the launch of Ontruzant in the U.S.

Ontruzant is used to treat patients with early breast cancer, metastatic breast cancer, and metastatic gastric cancer, and was the first trastuzumab biosimilar to receive regulatory approval in Europe. Its original, Herceptin, is one of the world’s most purchased medicines with an annual sale of $6.9 billion in 2015.


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