Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nypozi (TX01). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.
Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.
New Zealand has announced that, in order to widen access to adalimumab, it will now fund the adalimumab biosimilar Amgevita.
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved three bevacizumab.
South Korean biotechnology company Celltrion announced in October 2021 that it had applied for marketing approval for its candidate bevacizumab biosimilar (CT P16) in Europe, Korea and the US.
Japan-based Mochida Pharmaceutical (Mochida) announced on 25 November 2021 that its adalimumab biosimilar had been launched in Japan following the listing of the drug on the National Health Insurance (NHI).
China’s National Medical Products Administration (NMPA) has accepted a marketing authorization application for Bio-Thera Solutions’ (Bio-Thera) copy biological of tocilizumab, an immunosuppressant used in the treatment of arthritis.
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the Pharmaceutical Benefits Scheme (PBS) listing for the rituximab biosimilars Riximyo and Truxima be changed to ‘Unrestricted Benefit listings’.
Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.
China-based drugmaker SinoCellTech (formerly known as Shenzhou Cell) announced on 23 July 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its recombinant human coagulation factor VIII (susoctocog alfa) copy biological Anjian.