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Comments on TGA’s modified approach to naming biologicals Policies & Legislation | Posted 09/02/2018

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), opened a consultation on how to name biologicals in July 2017. It has now received comments on its proposals to expan...

Quebec adds biosimilar etanercept Erelzi to public drug plan Biosimilars/General | Posted 09/02/2018

In August 2017, Sandoz, the generics division of Novartis, announced that its etanercept biosimilar, Erelzi, was now available in Canada [1], after the company received Health Canada approval for t...

Approval rating and opinion on generic drugs in Italy: a cross-sectional study in the Liguria region Generics/Research | Posted 09/02/2018

Italy has the lowest generics market share by volume in Europe (less than 20%), coming just below Portugal and Spain. While in Northern European countries the introduction of generics took place be...

Structure-function relationship between disulfide bonds and TNF-α neutralization in etanercept Biosimilars/Research | Posted 09/02/2018

Research carried out by Sandoz describes how a novel incorrect disulfide bridge structure present at low levels in commercial etanercept inhibits etanercept potency by reducing its ability to neutr...

Denosumab biosimilar being developed in Australia Biosimilars/News | Posted 09/02/2018

Australian biologicals company NeuClone disclosed on 5 January 2018 the fifth biosimilar candidate that the company is developing in its pipeline of monoclonal antibody (mAb) products. The product...

Collaborative approach to use of biosimilars Reports | Posted 09/02/2018

The importance of having a collaborative approach for the use of biosimilars was a topic discussed during the European Commission’s (EC) third Multi-stakeholder Workshop on Biosimilar Medicinal Pro...

FDA agrees to meet GAO demands on revised guidance for complex generics Guidelines | Posted 09/02/2018

The US Government Accountability Office (GAO) released a report on 16 January 2018, in which it stated that the US Food and Drug Administration (FDA) should release plans to issue or revise gu...

Medicines for Europe 14th Legal Affairs Conference Conferences | Posted 09/02/2018

14th Legal Affairs Conference 25 April 2018 Grange Tower Bridge HotelLondon, UK