Biosimilars/News
EC and FDA approval for first ranibizumab biosimilar Byooviz
On 18 August 2021, the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received European Commission (EC) approval. Then on 20 September 2021 the pair announced that Byooviz had also received approval from the US Food and Drug Administration (FDA). This is the first ranibizumab biosimilar, or indeed ophthalmology biosimilar, to receive approval in either Europe or the US.
EC approval for insulin aspart biosimilar Kixelle
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
Canada’s drug regulator, Health Canada, has approved the insulin aspart biosimilar Trurapi.
EMA recommends approval of insulin aspart biosimilar Kixelle
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
New bevacizumab biosimilars have been launched in Spain and South Korea.
Mabpharm gains approval for infliximab biobetter in China
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
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
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
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
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.
