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CESP makes submissions totally electronic

Published on 2013/02/25

The Dutch Medicines Evaluation Board (CBG-MEB) announced on 1 November 2012 that starting from 12 November 2012, it will be possible to submit applications for marketing authorizations and deviations ...

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Comparison of EPARs for G-CSF biosimilars approved in Europe

Published on 2013/02/22

EMA approved its first biosimilar granulocyte colony-stimulating factor (G-CSF, filgrastim) for use in Europe back in 2008, since then, several biosimilar G-CSFs have been approved, including Biograst...

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Overview of research on â€˜specificâ€™ policies aimed at generics in 2012

Published on 2013/02/20

Period: January to August 2012Â Countries around the world have embraced generics due to their cost-saving potential. Many governments already have policies in place to promote the use of generic ...

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Overview of research on manufacturing statistics and innovations of biosimilars in 2012

Published on 2013/02/18

Period: January to August 2012Â Manufacturing of biosimilars is much more challenging than producing traditional small molecule generics. Reasons for this include, in the first place, the huge cos...

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Teva cost-cutting and re-organization

Published on 2013/02/15

Teva Pharmaceutical Industriesâ€™ (Tevaâ€™s) new Chief Executive vowed to reshape the drugmaker and reduce annual costs by up to US$2 billion over the next five years, making it into â€˜...

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Generic drug prices decrease, brand-name prices increase

Published on 2013/02/13

Over the last year brand-name drugmakers have raised prices by 13.3%, more than six times the consumer inflation rate. Generic drug prices, on the contrary; actually decreased by 21.9% during the same...

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History of biosimilar monoclonal antibodies regulation in EU

Published on 2013/02/11

Monoclonal antibodies (mAbs) are high molecular weight proteins (~150 kDa), with highly complex secondary and tertiary structures, subject to post-translational modifications, such as glycosylation. ...

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Marvel withdraws biosimilar insulin applications

Published on 2013/02/08

EMA announced on 27 November 2012 that it had been informed by Marvel LifeSciences (Marvel) that the company would be withdrawing its authorization applications for its three biosimilar human insulins...

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Overview of research on regulatory issues surrounding biosimilars in 2012

Published on 2013/02/06

Period: January to August 2012 In the area of regulation of biosimilars Europe has by far the best-established framework for approval and EMA has already issued both general and product specific gu...

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Biosimilar policies in the UK

Published on 2013/02/04

The UK was placed in 10th position in the global pharmaceutical markets in 2011. The UK also had some of the lowest prices for medicines in Europe. Cost pressures and a well-developed generics market ...

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Overview of research on â€˜generalâ€™ policies aimed at generics in 2012

Published on 2013/02/01

Period: January to August 2012Â Many governments around the world already have policies in place to promote the use of generic medicines, and with the increasing cost of health care and restrictio...

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Biosimilars approved and marketed in Germany

Published on 2013/01/30

Last updated: 23 November 2012Â The Federal Institute for Drugs and Medical Devices (Bundesinstitut fÃ¼r Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing ...

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