Biosimilars/News

Trastuzumab biosimilar Ogivri approved in Canada

Biosimilars/News | Posted 07/06/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 22 May 2019 that Health Canada had approved Mylan’s trastuzumab biosimilar Ogivri.

NeuClone to start phase I trial for ustekinumab biosimilar

Biosimilars/News | Posted 31/05/2019

Australian biologicals company NeuClone announced on 15 May 2019 that it would start a phase I clinical trial of its ustekinumab biosimilar, NeuLara, in the second half of 2019.

Russian approval for non-originator eculizumab

Biosimilars/News | Posted 24/05/2019

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 9 April 2019 that the Russian Ministry of Health had approved their eculizumab non-originator biological drug, Elizaria. The drug is a non-originator biological of Soliris (eculizumab), which is made by Alexion Pharmaceuticals.

Adalimumab biosimilar Idacio launched in Germany

Biosimilars/News | Posted 17/05/2019

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 3 May 2019 that it had launched its adalimumab biosimilar Idacio in Germany.

EMA approval for pegfilgrastim biosimilar Grasustek

Biosimilars/News | Posted 10/05/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek.

FDA approves etanercept biosimilar Eticovo

Biosimilars/News | Posted 03/05/2019

Korean biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 25 April 2019 that it had received approval from the US Food and Drug Administration (FDA) for its etanercept biosimilar.

Intas launches trastuzumab similar biologic in India at 65% discount

Biosimilars/News | Posted 26/04/2019

India-based generics maker Intas Pharmaceuticals (Intas) announced on 9 April 2019 the launch of its product Eleftha, a ‘similar biologic’ of trastuzumab, in India. The new product, claims the company, will bring down the cost of breast cancer treatment by nearly 65%.

Rituximab biosimilar Truxima approved in Canada

Biosimilars/News | Posted 19/04/2019

Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, announced on 10 April 2019 that Health Canada had approved its rituximab biosimilar Truxima. This marks the first rituximab biosimilar to be approved by the Canadian medicines’ regulator.

EC approval for adalimumab biosimilar Idacio

Biosimilars/News | Posted 12/04/2019

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar Idacio (MSB11455).

Sandoz resubmits pegfilgrastim biosimilar to FDA

Biosimilars/News | Posted 05/04/2019

Sandoz, the generics division of Novartis, announced on 3 April 2019 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the US Food and Drug Administration (FDA).