Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has initiated phase III trials for its denosumab biosimilar, while development on a rituximab biosimilar through subsidiary company Archigen Biotech has been stopped.
Samsung Bioepis has announced the start of phase III trials for their denosumab biosimilar, currently known as SB16. Denosumab is a monoclonal antibody treatment for osteoporosis, as well as other bone conditions, which has been sold by the originator company Amgen under the trade name Prolia. The antibody works by inhibiting the development of cells which break down bone, thus protecting bone from degradation.
The multinational trial involves 432 post-menopausal osteoporosis patients and will compare the efficacy and safety of SB16 with the originator drug. The development of SB16 has been accelerated via an ‘overlap’ strategy, allowing the phase III clinical trial to be conducted at the same time as phase I testing on healthy participants, which began on 10 November 2020 .
A Samsung Bioepis official commented: ‘We will speed up efforts to complete the clinical trials of SB16 to develop biosimilar drugs that would benefit more patients’.
In other news for Samsung, Samsung Biologics has now ceased research and development activities on their rituximab biosimilar, which can be used to treat autoimmune disease and certain types of cancer. The biosimilar, known as SAIT101, was being developed by Archigen Biotech, a joint venture between Samsung Biologics and UK firm Astra Zeneca.
According to a quarterly report from Samsung Biologics, the companies decided to suspend activities at Archigen Biotech in September 2020. As a result, Archigen Biotech will be liquidated.
Although a phase III trial for SAIT101 was completed in 2020 and with valid results, Samsung Biologics and Astra Zeneca deemed that the biosimilar would not be sufficiently competitive due to market entry of a number of other Rituxan biosimilars. Teva/Celltrion, for example, launched their biosimilar, Truxima, which has since been pre-qualified by the World Health Organization [2, 3].
A Samsung Biologics official commented that SAIT101 ‘lacks commercial viability’, however details of the liquidation, such as asset distribution, have not yet been released.
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Biosimilars of denosumab
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar advances for Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-advances-for-Samsung-Bioepis
2. GaBI Online - Generics and Biosimilars Initiative. Teva launches rituximab biosimilar Truxima in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22] Available from: www.gabionline.net/Biosimilars/News/Teva-launches-rituximab-biosimilar-Truxima-in-US
3. GaBI Online - Generics and Biosimilars Initiative. WHO prequalifies first rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 22]. Available from: www.gabionline.net/Biosimilars/General/WHO-prequalifies-first-rituximab-biosimilar
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