Biosimilars/News
EMA and FDA accept application for adalimumab biosimilar AVT02
Iceland-based biopharmaceutical company Alvotech announced on 19 November 2020 that its US subsidiary, Alvotech USA, had filed an application for its adalimumab biosimilar (AVT02). The company also announced that the European Medicines Agency (EMA) had accepted for review its application for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.
Trials of ustekinumab biosimilars advance
Japan-based Meiji Seika Pharma, together with the South Korean company Dong-A, have begun a phase I trial for their ustekinumab biosimilar. Meanwhile, the Australian firm NeuClone has reported results from the phase I trial of its ustekinumab biosimilar, NeuLara.
EMA recommends approval of bevacizumab biosimilar Onbevzi
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 November 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Onbevzi.
EMA accepts application for bevacizumab biosimilar BAT1706
China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 25 November 2020 that it had submitted an application for its proposed bevacizumab biosimilar, BAT1706, to the European Medicines Agency (EMA).
Australia approves etanercept and insulin aspart biosimilars
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), announced in October 2020 the approval of etanercept and insulin aspart biosimilars.
FDA accepts application for ranibizumab biosimilar
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) and partner US biotechnology company Biogen announced on 18 November 2020 that the US Food and Drug Administration (FDA) had accepted the application for their proposed ranibizumab biosimilar (SB11).
Canada approves enoxaparin biosimilars Inclunox and Noromby
Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.
Innovent and Eli Lilly receive approval for rituximab copy biological in China
Innovent Biologics and Eli Lilly have received joint marketing approval from the National Medical Products Administration (NMPA) in China for their rituximab copy biological, Halpryza.
Canada approves trastuzumab biosimilar Kanjinti
Canada’s medicines regulator, Health Canada, has approved the trastuzumab biosimilar Kanjinti by Amgen. This marks the second trastuzumab biosimilar to be approved by Health Canada.
EMA accepts application for ranibizumab biosimilar from Samsung Bioepis
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.
