Biosimilars/News
FDA accepts application for ranibizumab biosimilar
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) and partner US biotechnology company Biogen announced on 18 November 2020 that the US Food and Drug Administration (FDA) had accepted the application for their proposed ranibizumab biosimilar (SB11).
Canada approves enoxaparin biosimilars Inclunox and Noromby
Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.
Innovent and Eli Lilly receive approval for rituximab copy biological in China
Innovent Biologics and Eli Lilly have received joint marketing approval from the National Medical Products Administration (NMPA) in China for their rituximab copy biological, Halpryza.
Canada approves trastuzumab biosimilar Kanjinti
Canada’s medicines regulator, Health Canada, has approved the trastuzumab biosimilar Kanjinti by Amgen. This marks the second trastuzumab biosimilar to be approved by Health Canada.
EMA accepts application for ranibizumab biosimilar from Samsung Bioepis
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.
China accepts application for bevacizumab copy biological
The National Medical Products Administration (NMPA) in China has accepted an investigational new drug (IND) application for a bevacizumab copy biological developed by 3SBio and Samsung Bioepis.
EC approval for bevacizumab biosimilar Equidacent
Centus Biotherapeutics Ltd announced on 29 September 2020 that the European Commission (EC) granted marketing authorization for Equidacent, its Avastin (bevacizumab) biosimilar.
China approves adalimumab copy biological Sulinno
China-based Innovent Biologics (Innovent) has received marketing authorization from the National Medical Products Administration (NMPA) for their adalimumab copy biological Sulinno.
Cadila launches two new similar biologics in India
Cadila Pharmaceuticals (Cadila) has launched two similar biologics onto the Indian market: NuPTH, a teriparatide similar biologic and Cadalimab, a similar biologic of the auto-immune treatment adalimumab. Cadila has launched four new products on the domestic market since July 2020.
Biocon and Celltrion make progress in the battle against COVID-19
Biocon has reported promising results from a clinical trial of its biosimilar itolizumab in patients hospitalised with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Meanwhile, Celltrion Healthcare (Celltrion) is investigating the use of its infliximab biosimilar CT-P13 to treat patients with COVID-19 infection.
