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Samsung Biologics and AstraZeneca Dissolve Rituximab Partnership
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.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer
February 8th 2025A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
