News

Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.

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).

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.

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).

An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has been launched in Japan.

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.

The US Food and Drug Administration (FDA) announced on 4 June 2018 that it had approved its first pegfilgrastim biosimilar.

Turkish pharma start-up firm TRPharm announced on 9 March 2018 that it had received Turkish approval and was ready to launch its rituximab biosimilar Redditux.

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).

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).