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Extrapolation of indications in biosimilars: epoetin Biosimilars/Research | Posted 12/12/2014

Despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low, and especially in extrapolated* indications. Members of the European Medicines Agency's...

Canada’s generics are too expensive Generics/Research | Posted 12/12/2014

The same generics cost more in Canada than they do in similarly developed countries. In response to this, the premiers of each Canadian province recently agreed to lower the price of six expensive...

Non-biological complex drug concept: experiences with iron sucrose and low molecular weight heparin Biosimilars/Research | Posted 12/12/2014

When the patent of a classical small molecule drug expires, generics may be marketed if their therapeutic equivalence to the originator drug has been established. The therapeutic equivalence of a d...

Trade groups comment on China’s biosimilars guidance Policies & Legislation | Posted 12/12/2014

Trade groups: the Biotechnology Industry Organization (BIO) and the R&D-based Pharmaceutical Association Committee in China (RDPAC), both of which represent originator biologicals companies, ha...

EU Member States suspend generics approvals due to problems at CRO Generics/General | Posted 12/12/2014

The European Medicines Agency (EMA) announced on 5 December 2014 that some Member States have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of...

Momenta gains approval to start biosimilar adalimumab trial in Europe Biosimilars/News | Posted 12/12/2014

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 December 2014 the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a clinical tri...

UK uses less brand-name medicines per person Reports | Posted 12/12/2014

The UK uses fewer brand-name medicines per person than many other countries, but this means that the country tends to use older medicines rather than the latest ones, according to a new report.

First celecoxib generics hit US market Generics/News | Posted 12/12/2014

On 10 December 2014, generics makers Actavis, Mylan and Teva Pharmaceutical Industries (Teva) announced that they had all launched celecoxib generics in the US.