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MEPs adopt directive to give quicker access to generics Policies & Legislation | Posted 15/02/2013

Members of the European Parliament (MEPs) have adopted the text of the Transparency Directive 2012/0035(COD) by a large majority in a plenary session of the parliament on 6 February 2013.

AMAC and GPhA hit back at Big Pharma over biosimilars Biosimilars/News | Posted 15/02/2013

The Association of Mature American Citizens (AMAC) and the Generic Pharmaceutical Association (GPhA) have reacted strongly to the actions by Amgen and Genentech, which aim to make it more diff...

Biologicals boom Biosimilars/Research | Posted 15/02/2013

Researchers predict that the present list of top 10 blockbuster drugs will change dramatically by 2014. The predictions are that by 2014 biological drugs will topple the present market leaders Pfiz...

Draft revision of biosimilar low molecular weight heparin guideline Guidelines | Posted 08/02/2013

EMA announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs). The draft guideline...

Biotech firms try to limit biosimilar substitution in US Biosimilars/News | Posted 08/02/2013

FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.

Conflict-of-interest policies reduce brand-name prescribing Generics/Research | Posted 08/02/2013

Psychiatrists who are exposed to conflict-of-interest (COI) policies during their residency are less likely to prescribe brand-name antidepressants after graduation than those who train in residenc...

Assessment of biosimilarity under the BPCI Act Biosimilars/Research | Posted 08/02/2013

The Biologics Price Competition and Innovation (BPCI) Act defines a biosimilar as a product that is highly similar to the reference product notwithstanding minor differences in clinically inactive...

Generic Doxil approval may help alleviate drug shortages Pharma News | Posted 08/02/2013

FDA announced on 4 February 2013 that the agency had approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).