Merck to Spin Off Company That Will Include Its Biosimilar Marketing in 2021

On February 5, Merck announced that it will create a new spinoff that will include its biosimilar business with Samsung Bioepis as well as its legacy pharmaceuticals (e.g., Zetia®, Vytorin®, and other widely diversified brands). In its press release, Merck emphasized that the as-yet unnamed new company will also have a strong focus on women’s … Continue reading Merck to Spin Off Company That Will Include Its Biosimilar Marketing in 2021 →

Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar

And then there was one. Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant®, an approved Herceptin® biosimilar. A Joint Stipulation of Dismissal is usually the confirmation that a licensing agreement has been reached. This leaves one remaining approved trastuzumab biosimilar maker that has not settled … Continue reading Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar →

Samsung Bioepis Scores FDA Approval of Ontruzant, the Third Biosimilar Trastuzumab

The US Food and Drug Administration (FDA) announced on January 18, 2019 the approval of a new biosimilar version of trastuzumab. Produced by Samsung Bioepis, this agent was dubbed Ontruzant (trastuzumab-dttb). This is the third trastuzumab biosimilar approved by the FDA, following those by Mylan and Biocon in December 2017 (Ogivri®) and Teva and Celltrion … Continue reading Samsung Bioepis Scores FDA Approval of Ontruzant, the Third Biosimilar Trastuzumab →