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Generics may be allowed to change drug labelling Policies & Legislation | Posted 02/08/2013

FDA has proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers.

Regulation of similar biotherapeutic products in Latin America Biosimilars/Research | Posted 02/08/2013

Regulation of similar biotherapeutic products (SBPs) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region...

US healthcare professionals need more education on biosimilars Reports | Posted 02/08/2013

A study of healthcare professionals in North America found a lack of knowledge concerning biosimilars and a need for further education on biosimilars.

EMA approves first monoclonal antibody biosimilar Biosimilars/News | Posted 05/07/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 28 June 2013 that it had recommended granting of marketing authorization for the first mon...

EMA issues draft concept paper on comparing quality in biologicals and biosimilars Guidelines | Posted 05/07/2013

On 28 June 2013, the European Medicines Agency (EMA) released a draft concept paper to discuss the issue of how to compare the quality attributes for biological products and biosimilars. The draft...

Generics combo non-inferior to treatment with Enbrel Generics/Research | Posted 05/07/2013

A study carried out by researchers from the US Department of Veterans Affairs and the Canadian Institutes for Health Research has found that a combination of three generic drugs is non-inferior to...

Patient care threatened by cancer drug shortages Reports | Posted 05/07/2013

Drug shortages are affecting most US oncologists, impacting on life-saving patient care, according to the findings of the largest study yet to quantify the impact of cancer drug shortages [1]. Of 2...

Biosimilars applications under review by EMA – 2013 Q2 Biosimilars/General | Posted 05/07/2013

Last update: 15 October 2013 The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established...