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Brazilian guidelines for follow-on biological products Guidelines | Posted 08/06/2012

Last update: 31 October 2013The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which was cr...

Prescriber caution is likely over biosimilars Biosimilars/Research | Posted 01/06/2012

The experience with generic medicines is a sign that prescribers are likely to be cautious, and in some cases concerned, about the use of biosimilars as alternatives to brand-name drugs.

Biosimilars: key players and global market trends Reports | Posted 01/06/2012

Biosimilars are approaching a turning point in their evolution, although positive moves are being made, there is still much that has to change in order to create a global market that can sustain bi...

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FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.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