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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...

Bulgaria and Cyprus added to EU-US mutual recognition agreement Policies & Legislation | Posted 14/06/2019

The European Medicines Agency (EMA) announced on 29 April 2019 that the mutual recognition agreement (MRA) between the European Union (EU) and the US had been extended to include two additional EU...

Biosimilars to replace older biologicals for IBD Biosimilars/Research | Posted 07/06/2019

Biosimilars will gradually replace older biological drugs for IBD, however, issues – such as the safety of multiple switches – remain, says a recent assessment published in Digestive Diseases and S...

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.

Irish hospitals to get incentives to switch patients to biosimilars Biosimilars/General | Posted 07/06/2019

Hospitals in Ireland are being offered a Euros 500 incentive for every patient they switch off two expensive biologicals to cheaper biosimilars.

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 approv...

Dramatic price reduction of trastuzumab in Malaysia Biosimilars/General | Posted 07/06/2019

The price of the cancer drug trastuzumab has dropped by more than half in Malaysia following a recent tender to the Ministry of Health.

US considering eight years protection for biologicals in China Policies & Legislation | Posted 07/06/2019

Makers of copy biologicals in China may be set to get a further boost, as the Trump administration is said to be considering conceding to China’s proposal to shorten the period of protection grante...