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Biosimilars/News

FDA V17F30

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.

Health Budget 1 V13D12

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%.

Health Canada V13I20

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.

Approved V13G05

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).

Checklist V14A17

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).

Approved-V13G05

Japanese approval for Lupin’s etanercept biosimilar

Biosimilars/News | Posted 01/04/2019

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 26 March 2019 that its joint venture YL Biologics and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry) had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan.

Toclizumab Roche V16G29

Bio-Thera advances bevacizumab and tocilizumab copy biologicals

Biosimilars/News | Posted 01/04/2019

China-based Bio‑Thera Solutions (Bio‑Thera) has made a licensing agreement for its bevacizumab copy biological and has started a phase III trial for its tocilizumab copy biological.

Trastuzumab Herceptin V13D12

FDA approves trastuzumab biosimilar Trazimera

Biosimilars/News | Posted 22/03/2019

Pharma giant Pfizer announced on 11 March 2019 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Roche’s Herceptin (trastuzumab).

Rituximab V13D29

China approves rituximab copy biological

Biosimilars/News | Posted 15/03/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological.

Chemotherapy V13E17

UK’s NICE recommends pertuzumab with biosimilar trastuzumab

Biosimilars/News | Posted 15/03/2019

The UK’s National Institute for Health and Care Excellence (NICE) has recommended originator pertuzumab with intravenous biosimilar trastuzumab and chemotherapy for the treatment of breast cancer.