Biosimilars/News
China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806
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 PBAC recommends unrestricted benefit listing for rituximab biosimilars
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 approves filgrastim and insulin aspart biosimilars Nypozi and Kirsty
Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.
China approves Factor VIII copy biological Anjian
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.
FDA approves adalimumab biosimilar Cyltezo as interchangeable
The US Food and Drug Administration (FDA) has approved the first interchangeable adalimumab biosimilar. This is the second interchangeable biosimilar to gain FDA approval in the US and follows the landmark decision to approve an interchangeable insulin glargine biosimilar in July 2021 [1].
Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars
China’s Bio-Thera Solutions and South Korea’s Samsung Bioepis have begun phase III clinical trials for biosimilars to Janssen’s blockbuster anti-inflammatory drug Stelara (ustekinumab).
Canada approves adalimumab and bevacizumab biosimilars
Canada’s drug regulator, Health Canada, has approved the bevacizumab biosimilar Bambevi and the adalimumab biosimilar Abrilada (PF-06410293).
Bioeq submits application for ranibizumab biosimilar to FDA
A ranibizumab biosimilar developed by Swiss biotechnology company Bioeq AG (Bioeq) has been successfully submitted to the US Food and Drug Administration (FDA) for review.
CuraTeQ submits application to EMA for pegfilgrastim biosimilar
India-based generics maker Aurobindo Pharma (Aurobindo) announced on 22 September 2021 that its subsidiary CuraTeQ Biologics (CuraTeQ) had submitted an application to the European Medicines Agency (EMA) for its pegfilgrastim biosimilar, BP14.
EMA recommends approval of two adalimumab biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 17 September 2021 that it had recommended granting marketing authorization for the adalimumab biosimilars Hukyndra and Libmyris.
