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Hospira recalls overfilled hydromorphone hydrochloride vials Generics/News | Posted 01/06/2012

Hospira first alerted FDA in April and May 2012 of overfilled cartridges containing morphine and hydromorphone. Subsequent investigation by the company has revealed that as many as 280 batches...

Alternative delivery devices for biosimilars Biosimilars/News | Posted 01/06/2012

FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.

Efficacy and tolerability of generic and brand-name atorvastatin Generics/Research | Posted 01/06/2012

A generic formulation of atorvastatin was developed in Korea and approved by Korea Food and Drug Administration on 1 July 2008. This clinical trial was conducted at ten clinical centres in Korea be...

Biosimilars approved and marketed in The Netherlands Biosimilars/General | Posted 01/06/2012

Last updated: 1 June 2012The Dutch Medicines Evaluation Board (MEB) – College ter Beoordeling van Geneesmiddelen (CBG) – is responsible for the approval of marketing authorisation of...

FDA’s public hearing on biosimilars draft guidances Biosimilars/General | Posted 25/05/2012

On 11 May 2012, FDA held a public hearing to gain input on their draft guidances relating to the development of biosimilar products and it seems that the guidances were generally well accepted.

Increased use of generic statins proves cost effective in Australia Generics/Research | Posted 25/05/2012

A recent study concluded that closing the statin ‘treatment gap’ using generics was cost-effective in the secondary prevention of coronary artery disease (CAD) in Australia [1].

Immunogenicity of biologicals Biosimilars/Research | Posted 25/05/2012

This article discusses the issue of immunogenicity with respect to originator biologicals and biosimilars [1].

Generics makers cannot gain access to some brand-name drugs Generics/News | Posted 25/05/2012

Generics manufacturers trying to create generics for certain drugs are having problems gaining access to samples of the brand-name drugs due to restrictions on supply put in place by FDA.