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An obstacle in Celltrion’s path to sell its rituximab biosimilar in Korea has been removed, with a court’s affirmation that a patent covering Genentech/Biogen’s Rituxan original for the use of chronic lymphocytic leukemia is invalid.
Sued by Herceptin sponsor Genentech for patent infringement, Samsung Bioepis has legal hurdles to navigate before it can roll out its trastuzumab biosimilar in the US, which has just become the third biosimilar of the cancer treatment greenlit by the FDA.
In line with its strategy to establish its presence in the US branded market, Aurobindo has through its subsidiary Acrotech Biopharma acquired seven marketed oncology injectables from Spectrum Pharmaceuticals in a deal worth up to US$300 million.
Prioritizing the approval of generics of medicines with little or no competition has been a key part of the FDA’s efforts to support access and reduce costs to patients; the agency has just granted Teva approval for the first generic version of Lundbeck’s Sabril (vigabatrin) 500mg tablets.
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