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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.

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).