30 Dec 21 | US | Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the US Patent and Trademark Appeal Board’s decisions of unpatentability for five device patents for Sanofi’s Lantus® (insulin glargine) SoloSTAR® as well as a district court decision on one of these patents. Biocon and Viatris launched Semglee® (interchangeable biosimilar insulin glargine) in November 2021.
05 Jan 22 | US | Samsung Bioepis and Organon announced that the FDA has accepted for review the supplemental Biologics License Application for a citrate-free, high-concentration formulation of SB5 (biosimilar adalimumab). Organon expects to launch this product in the US on or after 1 July 2023, in accordance with a licensing agreement with AbbVie.
05 Jan 22 | Amneal Pharmaceuticals and Saol Therapeutics announced that Amneal will acquire Saol’s Baclofen franchise. This acquisition is expected to bolster Amneal’s commercial infrastructure in advance of its planned launches of biosimilar filgrastim, biosimilar pegfilgrastim and biosimilar bevacizumab in 2022.
07 Jan 22 | Coherus Biosciences announced that it has entered into a loan agreement with investment funds managed by Pharmakon Advisors, LP. The agreement will provide Coherus with up to $300 million committed across four tranches. The third and fourth tranches are conditional upon Coherus receiving approval of the BLA for its toripalimab and its biosimilar ranibizumab, respectively.