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FDA accepts biosimilar filgrastim application Biosimilars/News | Posted 01/08/2014

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 24 July 2014 that the US Food and Drug Administration (FDA) had accepted its application for approval of the company’s b...

Biosimilars of darbepoetin alfa Biosimilars/General | Posted 01/08/2014

Last update: 26 February 2016Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated...

Data protection provisions in CETA Generics/Research | Posted 01/08/2014

The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1]. In particular, certain intellectual property provi...

Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity Biosimilars/Research | Posted 01/08/2014

Results of phase I trials of pharma giant Pfizer’s biosimilar infliximab and rituximab candidates have demonstrated similar pharmacokinetic properties compared to the originator products [1, 2].

EC expected to dish out more pay-for-delay fines Policies & Legislation | Posted 01/08/2014

The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations o...

Healthcare providers concerned about FDA’s generics labelling rules Reports | Posted 01/08/2014

A survey by the Generic Pharmaceutical Association (GPhA) and the National Coalition on Healthcare (NCH) has revealed that healthcare providers have serious concerns about the US Food and Drug Admi...

Generic valsartan approved in US Generics/News | Posted 01/08/2014

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (F...

India planning to extend pricing control to more drugs Generics/General | Posted 01/08/2014

India is thought likely to increase the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.