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FDA approves biosimilar infliximab Renflexis

Samsung Bioepis announced on 24 April 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Remicade (infliximab).

EMA approval for etanercept and rituximab biosimilars

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 April 2017 that it had recommended granting marketing authorization for the etanercept biosimilar Erelzi and for the rituximab biosimilars Rixathon and Riximyo.

Advances in ranibizumab and teriparatide biosimilars

Positive results have been reported from a ranibizumab biosimilar and a teriparatide biosimilar has entered phase III trials.

Trastuzumab biosimilar submitted for approval in Japan

Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-P6, to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Basal analogue insulin ‘copy biological’ launched in Indonesia

Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.

EC approval for adalimumab biosimilar Amgevita

Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.

Amgen submits trastuzumab biosimilar to EMA

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

Global settlement clears a pathway for trastuzumab biosimilar

Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlement with Genentech and Roche in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licences for its trastuzumab biosimilar.

Russian approval for non-originator interferon beta-1a

Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s interferon beta-1a non-originator biological drug, BCD-033. The drug is a non-originator biological of Merck’s multiple sclerosis blockbuster Rebif (interferon beta-1a).

EC approval for first cancer biosimilar Truxima

South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) approval for the marketing authorization for its rituximab biosimilar Truxima.