Reports
Ireland’s drug shortages worsening
Drug shortages in Ireland have increased during the last 12 months, according to a recent survey of pharmacists in the country.
How to avoid drug shortages
Despite FDA having made progress in recent years to combat drug shortages, the issue is still a major problem for the agency. This very fact led to the agency requesting public comment on the subject in February 2013. Senior Vice President of Quality at Amgen, Mr Martin Van Trieste, makes some suggestions to ensure that patients continue to gain access to essential medicines [1].
US healthcare professionals need more education on biosimilars
A study of healthcare professionals in North America found a lack of knowledge concerning biosimilars and a need for further education on biosimilars.
Patient care threatened by cancer drug shortages
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 250 board-certified US oncologists surveyed in late 2012 and early 2013, 83% reported facing a drug shortage in the past six months, and 92% of those said their patients’ treatment had been affected.
Biosimilar competition in Europe
A study of five European Union (EU) countries has revealed that Germany provides the most favourable environment for uptake of biosimilars.
International harmonization for biosimilars
What is the possibility of international harmonization for biosimilars? EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury about this issue, as well as why the US is still lagging behind Europe in the biosimilars race.
Biosimilar monoclonal antibodies and pharmacovigilance in Europe
EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury about biosimilar monoclonal antibodies and pharmacovigilance for biosimilars in Europe.
Possibility of substitution of biosimilars in Europe
To date, 14 biosimilars within the product classes of human growth hormone (1), granulocyte colony-stimulating factor (8) and erythropoietin (5) have been approved in Europe [1]. EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury about substitution of biosimilars in Europe.
EMA’s Richardson talks about biosimilars in Europe
Biosimilars have been available in Europe for more than seven years. In the US, however, despite legislation being passed in 2010 to allow for a biosimilars pathway, a biosimilar has yet to be approved [1]. EMA Head of Biologicals Dr Peter Richardson speaks to BioCentury about a new report published by the European Commission (EC) and about biosimilars in Europe in general.
The best selling biotechnology drugs of 2008: the next biosimilars targets
Last updated: 20 September 2013
According to the report Market-Leading Biotechnology Drugs 2009: Blockbuster Dynamics in an Ailing Economy, sales of the top 10 biotech drugs exceeded US$41.5 billion (Euros 28.6 billion) in 2008.