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First generic versions of Duetact and Maxalt approved Generics/News | Posted 01/02/2013

First-to-file generics from Mylan and Sandoz have been approved by FDA for rizatriptan benzoate and pioglitazone hydrochloride/glimepiride tablets, respectively.

Biosimilarity and interchangeability under the BPCI Act Biosimilars/Research | Posted 24/01/2013

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 biosimilars. FDA then issued guidelines for biosimilar...

Pay-for-delay on the increase in the US Reports | Posted 24/01/2013

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 a new re...

Top 10 most read GaBI Online articles in 2012 Pharma News | Posted 24/01/2013

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 year for GaBI Online.

India issues more compulsory licences Policies & Legislation | Posted 24/01/2013

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 drugs before the patents expir...

Positive phase I data for infliximab biosimilar Biosimilars/Research | Posted 24/01/2013

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 t...

Generic antiepileptic drugs bioequivalent to brand-name drugs Generics/Research | Posted 24/01/2013

Results of a study, reported by Dr Ravi Juluru and co-authors at the American Epilepsy Society’s 66th Annual Meeting, held in San Diego, USA on 30 November–4 December 2012, shows that generic slow-...

ProCognia completes global glycoanalysis centre Biosimilars/News | Posted 24/01/2013

Israeli biotech company ProCognia announced on 14 January 2013 the completion of its global centre of excellence for glycoanalytics.