News
CESP makes submissions totally electronic
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… Read More »
Comparison of EPARs for G-CSF biosimilars approved in Europe
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,… Read More »
Overview of research on ‘specific’ policies aimed at generics in 2012
2013-02-20 Period: January to August 2012 Countries around the world have embraced generics due to their cost-saving potential. Many governments already have policies in place to… Read More »
Overview of research on manufacturing statistics and innovations of biosimilars in 2012
2013-02-18 Period: January to August 2012 Manufacturing of biosimilars is much more challenging than producing traditional small molecule generics. Reasons for this include, in the first… Read More »
Teva cost-cutting and re-organization
2013-02-15 Teva Pharmaceutical Industries’ (Teva’s) new Chief Executive vowed to reshape the drugmaker and reduce annual costs by up to US$2 billion over the next five… Read More »
Generic drug prices decrease, brand-name prices increase
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;… Read More »
History of biosimilar monoclonal antibodies regulation in EU
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. However,… Read More »
Marvel withdraws biosimilar insulin applications
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… Read More »
Overview of research on regulatory issues surrounding biosimilars in 2012
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… Read More »
Biosimilar policies in the UK
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… Read More »
