Tony Hagen is senior managing editor for The Center for Biosimilars®.
Their rituximab biosimilar candidate was advancing in clinical trials for equivalence but represented a business conflict.
Samsung Biologics has decided to abandon efforts to develop SAIT101, a rituximab biosimilar for the treatment of follicular lymphoma, according to a report in the Korea Biomedical Review.
The report cited a corporate financial disclosure and official statement this week that stated Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of the rituximab candidate. Samsung Biologics said the subsidiary would be dissolved.
There was a conflict of interest in that a member of the Samsung Group, Samsung Bioepis, was in business collaboration with Biogen, the original developer of Rituxan, the reference brand of rituximab, the report said.
The report estimated that Samsung Biologics had invested $126 million in Archigen Biotech since its founding in 2016. A global phase 3 trial of SAIT101 in patients with follicular lymphoma was completed in August 2020 and demonstrated similar therapeutic effects to the reference product, with an objective response rate of 66.3% vs 70.6% for the Republic of Korea–marketed version of rituximab, MabThera.
Phase 1 trial results of the biosimilar candidate vs MabThera in patients with rheumatoid arthritis demonstrated therapeutic equivalence.