Biosimilars/News

Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea

Biosimilars/News | Posted 03/12/2021

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.

Adalimumab biosimilar launched in Japan

Biosimilars/News | Posted 03/12/2021

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 accepts Bio-Thera’s application for tocilizumab copy biological BAT1806

Biosimilars/News | Posted 26/11/2021

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

Biosimilars/News | Posted 19/11/2021

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

Biosimilars/News | Posted 12/11/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.

China approves Factor VIII copy biological Anjian

Biosimilars/News | Posted 05/11/2021

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

Biosimilars/News | Posted 29/10/2021

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

Biosimilars/News | Posted 29/10/2021

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

Biosimilars/News | Posted 22/10/2021

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

Biosimilars/News | Posted 15/10/2021

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.