Biosimilars/News
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.
EMA approves bevacizumab and teriparatide biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 June 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Aybintio and for the teriparatide biosimilars Livogiva and Qutavina.
FDA approves pegfilgrastim biosimilar Nyvepria
Pharma giant Pfizer announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Nyvepria (HSP-130).
FDA approves Mylan’s adalimumab biosimilar Hulio
The US Food and Drug Administration (FDA) has approved Mylan/Fujifilm’s adalimumab biosimilar Hulio (adalimumab-fkjp) on 7 July 2020. The product is the sixth adalimumab biosimilar to be approved by FDA and is manufactured by Japan-based Fujifilm Kyowa Kirin Biologics.
