More Articles

Top 10 most read GaBI Online articles in 2014 Pharma News | Posted 16/01/2015

2014 was once again a busy year for biosimilars, ranging from revision of regulatory guidelines to naming and extrapolation. Biosimilars remain the hot topic for GaBI Online during 2014 and, in fac...

Patient perceptions of generics in Ireland Generics/Research | Posted 16/01/2015

In an attempt to benefit from the cost savings associated with use of generics, in June 2013 the Irish Government introduced generics substitution and reference pricing for the first time via the H...

Hospira submits application to FDA for epoetin alfa biosimilar Biosimilars/News | Posted 16/01/2015

US-based injectables specialist Hospira announced on 12 January 2015 that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its epoetin alfa bi...

Biocomparable has comparable safety and efficacy to originator erythropoietin in haemodialysis patients Biosimilars/Research | Posted 16/01/2015

A study of the treatment of patients with chronic kidney disease undergoing haemodialysis with ‘biocomparable’ and originator erythropoietin in Mexico has shown comparable efficacy and safety in te...

Apotex pegfilgrastim biosimilar under FDA review Biosimilars/News | Posted 16/01/2015

Canada-based Apotex announced on 17 December 2014 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neulasta (pegf...

EMA issues revised guideline on non-clinical and clinical issues for biosimilars Guidelines | Posted 16/01/2015

On 18 December 2014, the European Medicines Agency (EMA) published the new version of its guideline addressing the non-clinical and clinical issues related to similar biological products (biosimila...

US judge invalidates 4 of 5 patents on Cubicin Generics/News | Posted 16/01/2015

A US federal judge has invalidated four out of the five patents on antibiotic Cubicin (daptomycin), paving the way for generics from June 2016.

Compromise reached on US legislation on biosimilars substitution Policies & Legislation | Posted 16/01/2015

Biologicals companies, including Amgen, Actavis, Sandoz, Hospira and Genentech, and the Generic Pharmaceutical Association (GPhA) have agreed to support compromise automatic substitution legislatio...