Menu

Biosimilars/News

Trastuzumab Herceptin V13D12

Trastuzumab biosimilar from Prestige accepted for review by EMA

Biosimilars/News | Posted 14/06/2019

Singapore-based Prestige BioPharma (Prestige) announced on 28 May 2019 that the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medicines Agency (EMA).

01 AA007239

Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb)

Biosimilars/News | Posted 14/06/2019

South Korean biosimilars firm Celltrion announced on 23 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Herzuma (trastuzumab-pkrb).

122 MD002454

Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system

Biosimilars/News | Posted 14/06/2019

Sandoz, the generics division of Novartis, announced on 9 May 2019 that it had received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin, under the recently introduced Quality Consistency Evaluation (QCE) system.

02 AA010638

Brazilian approval for trastuzumab follow-on biological Ontruzant

Biosimilars/News | Posted 07/06/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 27 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Ontruzant.

health budget cuts 2 V13l06

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.

Clinical Trials 2 V13K29

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.

Biosimilars V13E10

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 V13F21

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.

Approved V13G05

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 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.