News

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.

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.

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. 

Centus Biotherapeutics Ltd announced on 29 September 2020 that the European Commission (EC) granted marketing authorization for Equidacent, its Avastin (bevacizumab) biosimilar.

China-based Innovent Biologics (Innovent) has received marketing authorization from the National Medical Products Administration (NMPA) for their adalimumab copy biological Sulinno. 

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 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.

The indications of Merck Canada’s etanercept biosimilar Brenzys have been expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis.

The partnership of US-based drugmaker Mylan and Indian biologicals specialist Biocon announced on 31 August 2020 the launch of their insulin glargine product, Semglee, in the US. 

South Korean biotechnology company Samsung Bioepis has announced the launch of their trastuzumab biosimilar Ontruzant in Brazil. The product was approved by the Brazilian health agency in May 2019.