News

New pharmaceutical law promotes generics in Chile

Published on 2012/09/21

In July 2012, a new pharmaceutical law was introduced in Chile. The new law aims to regulate generics bioequivalence in the country as well as enforce prescription by generic name in order to increase...

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EMA finalises pharmacovigilance guidance

Published on 2012/09/19

EMA announced on 25 June 2012 the release of the finalised versions of seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-...

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India releases draft ‘similar biologic’ guidelines

Published on 2012/09/17

India has released regulatory guidelines outlining a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than fou...

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EMA responds to questions over biosimilar comparability

Published on 2012/09/12

EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that demonstrate qualit...

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Guidelines for substitution of generics in The Netherlands

Published on 2012/09/03

Marketed medicines that have passed bioequivalence testing should in general be substitutable. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharma...

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Biosimilars policies in Italy

Published on 2012/08/31

According to the 2011 report by Rovira et al., biosimilars commercialised in Italy show a low penetration both in the total market (0.01%) and in the biological market (0.3%). However, in order to try...

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EU guidelines for biosimilars

Published on 2012/08/29

The regulatory body for approval of medicines in the EU is EMA. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU. All medic...

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WHO guidelines on biosimilars: case studies and discussion highlights

Published on 2012/08/27

The experiences and progress of different countries in implementing WHO guidelines on evaluating biosimilars were the focus of a workshop hosted jointly by WHO and Korea Food and Drug Administration (...

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EMA opens up access to reports on suspected drug side effects

Published on 2012/08/24

In its commitment to transparency, EMA, on 31 May 2012, opened up access to reports on suspected drug side effects. The database contains reports on around 650 medications and active ingredients, incl...

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EMA revised guideline on quality of biosimilar medicines open for comments

Published on 2012/08/22

EMA announced on 31 May 2012 that it had released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines. The g...

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Attitudes and beliefs are powerful influences on generics use

Published on 2012/08/20

While generic drugs have the potential to provide significant savings in healthcare costs, and numerous financial incentives are in place, the generics substitution rate in Switzerland was, until rece...

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Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs

Published on 2012/08/17

Pharma major Merck KGaA announced on 6 June 2012 its first steps into the biosimilars market, with an agreement with India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) to co-de...

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