Biosimilars/News
FDA rejects Amgen’s trastuzumab biosimilar
Biotech giant Amgen announced on 4 June 2018 that the US Food and Drug Administration (FDA) had rejected the application for approval of its trastuzumab biosimilar.
Celltrion resubmits biosimilar trastuzumab to FDA
South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing approval for its candidate trastuzumab biosimilar, CT‑P6, to the US Food and Drug Administration (FDA).
Etanercept biosimilars submitted to EMA and launched in Japan
An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has been launched in Japan.
EMA approves adalimumab and trastuzumab biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 June 2018 that it had recommended granting marketing authorization for the adalimumab biosimilars Halimatoz, Hefiya and Hyrimoz, and also for the trastuzumab biosimilar Trazimera.
FDA approval for pegfilgrastim biosimilar Fulphila
The US Food and Drug Administration (FDA) announced on 4 June 2018 that it had approved its first pegfilgrastim biosimilar.
Celltrion resubmits biosimilar rituximab to FDA
South Korean biotechnology company Celltrion announced on 30 May 2018 that it had resubmitted its application for marketing approval for its candidate rituximab biosimilar, CT‑P10, to the US Food and Drug Administration (FDA).
EC approval for infliximab biosimilar Zessly
Sandoz, the generics division of Novartis, announced on 24 May 2018 that it had received European Commission (EC) approval for its infliximab biosimilar Zessly (PF‑06438179).
Hetero launches adalimumab similar biologic in India
India-based generics maker Hetero Group (Hetero) announced in January 2018 the launch of its product Mabura, a ‘similar biologic’ of adalimumab, in India.
Pegfilgrastim biosimilar Lapelga approved in Canada
Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision made on 5 April 2018. This marks the first pegfilgrastim biosimilar to be approved by the Canadian medicines regulator.
FDA approves epoetin alfa biosimilar Retacrit
The US Food and Drug Administration (FDA) approved its first epoetin alfa biosimilar on 15 May 2018.
