Biosimilars/News
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).
EC approval for trastuzumab biosimilar Zercepac
The European Commission (EC) has granted marketing authorization for the trastuzumab biosimilar Zercepac (HLX02) on 27 July 2020. The product is produced by the Shanghai Henlius Biopharmaceutical Co Ltd (Henlius), making it the first China-made biosimilar to receive approval in Europe.
EMA recommends approval of bevacizumab biosimilar Equidacent
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab biosimilar Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics
EC approval for Sanofi’s insulin aspart biosimilar
The European Commission (EC) has issued marketing authorization for Sanofi’s insulin aspart biosimilar, which references Novo Nordisk’s product NovoLog and is used to treat type 1 and 2 diabetes.
