Biosimilars/News
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.
Indications expanded for Merck’s etanercept biosimilar Brenzys
The indications of Merck Canada’s etanercept biosimilar Brenzys have been expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis.
Insulin glargine biosimilar Semglee launched in US
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.
Samsung Bioepis launches Ontruzant in Brazil
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.
Cadila Pharmaceuticals launches two similar biologics in India
Indian generics maker Cadila Pharmaceuticals Ltd (Cadila) has launched two new similar biologics in the country: Bevaro (bevacizumab) and Ritucad (rituximab).
