News
HIV generics could significantly cut treatment costs
2013-04-12 The US Government could save almost US$1 billion in the first year alone by using generic rather than brand-name drugs for the treatment of HIV… Read More »
Top developments in biosimilars during 2012
2013-04-10 Much has happened in the biosimilars’ industry over the last year. One of the most important developments during 2012 was the progress made in the… Read More »
Mobilization of stem cells in healthy donors by G-CSF biosimilars shows comparable efficacy and safety to Neupogen
2013-04-08 Originator human recombinant granulocyte colony-stimulating factor (G-CSF) filgrastim has been widely used for the mobilization of CD34+ stem cells in healthy donors. However, there is limited… Read More »
Overview of research on regulatory issues for generics in 2012
2013-04-05 Period: January to August 2012 Regulatory issues are a challenge facing generics of all kinds, and one that may limit the competitiveness and sustainability of… Read More »
Positive phase I data for infliximab biosimilar
2013-04-03 US-based Epirus Biopharmaceuticals (Epirus) announced on 4 January 2013 that its biosimilar infliximab candidate had ‘achieved bioequivalence’ to Remicade (infliximab) in a single dose comparator… Read More »
Generic antiepileptic drugs bioequivalent to brand-name drugs
2013-04-01 Results of a study, reported by Dr Ravi Juluru and colleagues at the American Epilepsy Society’s 66th Annual Meeting, held in San Diego, USA on… Read More »
India issues more compulsory licences
2013-03-29 The Indian Government is once again planning to issue compulsory licences for three patented cancer drugs, allowing local drugmakers to launch generic versions of the… Read More »
Top 10 most read GaBI Online articles in 2012
2013-03-27 2012 was a busy year with lots of developments in biosimilars from regulatory guidelines to comparability issues. Biosimilars remain as the hot topic of the… Read More »
Pay-for-delay on the increase in the US
2013-03-25 During 2012 the number of potentially anticompetitive patent dispute settlements between brand-name and generics companies in the US increased significantly compared with 2011 according to… Read More »
Biosimilarity and interchangeability under the BPCI Act
2013-03-22 In the US, the Biologics Price Competition and Innovation (BPCI) Act was signed into law on 23 March 2010, giving FDA the authority to approve… Read More »
