Biosimilars/News

EC approval for insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 26/03/2021

The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.

Canada approves insulin aspart biosimilar Trurapi

Biosimilars/News | Posted 12/02/2021

Canada’s drug regulator, Health Canada, has approved the insulin aspart biosimilar Trurapi.

EMA recommends approval of insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 29/01/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Bevacizumab biosimilars launched in Spain and Korea

Biosimilars/News | Posted 17/09/2021

New bevacizumab biosimilars have been launched in Spain and South Korea.

Mabpharm gains approval for infliximab biobetter in China

Biosimilars/News | Posted 10/09/2021

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 20 July 2021 that its partner, China-based Mabpharm, had received marketing approval from China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for its infliximab ‘biobetter’ (CMAB008).

Formycon/Bioeq submit European marketing authorization for ranibizumab biosimilar

Biosimilars/News | Posted 03/09/2021

German-headquartered companies Formycon and Bioeq have announced a European marketing authorization application for their ranibizumab biosimilar, FYB201.

Human insulin ‘similar biologic’ InsuTrend launched in India

Biosimilars/News | Posted 27/08/2021

India-based company Anthem Biosciences (AnthemBio) announced that it has launched its human insulin ‘similar biologic’ InsuTrend in India.

EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 16/07/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen.

Canada approves rituximab biosimilar Riabni

Biosimilars/News | Posted 09/07/2021

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilar Riabni for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

Canada approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 02/07/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nyvepria (PF-06881894). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.