Biosimilars/News
EMA approves adalimumab and pegfilgrastim biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 July 2018 that it had recommended granting marketing authorization for the adalimumab biosimilar Hulio and also for the pegfilgrastim biosimilars Pelgraz and Udenyca.
FDA approves filgrastim biosimilar Nivestym
On 20 July 2018, the US Food and Drug Administration (FDA) approved its second filgrastim biosimilar. The filgrastim biosimilar, Nivestym (filgrastim-aafi), is produced by US pharma giant Pfizer.
Rituximab biosimilar submitted to EMA and Rituxan gains extra indication
Poland-based Mabion announced on 1 June 2018 that its candidate rituximab biosimilar (MabionCD20) had been accepted for regulatory review by the European Medicines Agency (EMA).
Pfizer gains Japanese approval for infliximab biosimilar
Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.
FDA rejects botulinum toxin biosimilar from Evolus
US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of DWP‑450 (prabotulinumtoxinA).
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.
