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Overview of research on manufacturing statistics and innovations of biosimilars in 2012 Biosimilars/Research | Posted 14/12/2012

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 place, the huge...

India’s patent office at odds with Big Pharma Policies & Legislation | Posted 14/12/2012

India and its patent laws are increasingly being challenged by Big Pharma. In its most recent decision, the Indian Patent Office has rejected AstraZeneca’s patent appeal on Iressa (gefitinib). Some...

Overview of research on ‘specific’ policies aimed at generics in 2012 Generics/Research | Posted 14/12/2012

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 promote the use of gener...

Comparison of EPARs for G-CSF biosimilars approved in Europe Biosimilars/Research | Posted 14/12/2012

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 Biogr...

CESP makes submissions totally electronic Guidelines | Posted 14/12/2012

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 deviatio...

Originator biologicals approved and marketed in Germany Biosimilars/General | Posted 14/12/2012

Last updated: 14 December 2012 The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing...

Black-box safety warnings and the future of generic drug liability Generics/Research | Posted 07/12/2012

Generic medicines currently have no responsibility for adding warnings about adverse effects of their medicines. Despite the US Supreme Court ruling that it was ‘impossible’ to force generics manuf...

Overview of research on regulatory issues surrounding biosimilars in 2012 Biosimilars/Research | Posted 07/12/2012

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 specif...