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FDA issues final guidance on biosimilar user fees Guidelines | Posted 20/07/2018

The US Food and Drug Administration (FDA) has issued final guidance on the agency’s Biosimilar User Fee Act (BsUFA) II fee structure finalizing the changes introduced since BsUFA I.

Positive phase III results for Amgen’s infliximab biosimilar Biosimilars/Research | Posted 20/07/2018

Biotech giant Amgen announced on 27 June 2018 positive data from a phase III study of their infliximab biosimilar (ABP 710) compared to Remicade (infliximab).

Patient sociodemographics and use of generics Generics/Research | Posted 20/07/2018

Researchers from the US have found that poorer patients are more likely to use generics [1].

Mylan and Lupin make deal for etanercept biosimilar Pharma News | Posted 20/07/2018

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) and US-based drugmaker Mylan announced on 28 June 2018 that they had made a deal to commercialize an etanercept biosimilar.

Russian court approves first compulsory licence Policies & Legislation | Posted 20/07/2018

A court in Moscow has made history by granting a compulsory licence to Russian drugmaker Ukrenergo to make a generic version of Celgene Corporation’s (Celgene) flagship blood cancer drug Revlimid (...

MSF challenges hepatitis C patent in China Generics/General | Posted 20/07/2018

Médecins Sans Frontières (MSF, Doctors Without Borders) announced on 19 June 2018 that it was challenging the ‘unmerited’ patent in China for hepatitis C medicine velpatasvir from Gilead Sciences (...

Rituximab biosimilar submitted to EMA and Rituxan gains extra indication Biosimilars/News | Posted 20/07/2018

Poland-based Mabion announced on 1 June 2018 that its candidate rituximab biosimilar (MabionCD20) had been accepted for regulatory review by the European Medicines Agency (EMA).

Generic cancer pain relief launched in Japan Generics/News | Posted 20/07/2018

Japan-based Daiichi Sankyo announced on 15 June 2018 that it had launched a generic version of cancer pain relief Fentos Tape (fentanyl citrate tape).