Reports

How to avoid drug shortages

Home/Reports | Posted 09/08/2013

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

Home/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.

Patient care threatened by cancer drug shortages

Home/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 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

Home/Reports | Posted 05/07/2013

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

Home/Reports | Posted 28/06/2013

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

Home/Reports | Posted 21/06/2013

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

Home/Reports | Posted 14/06/2013

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

Home/Reports | Posted 07/06/2013

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

Home/Reports | Posted 14/10/2009

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.

Amgen, Hospira and Sandoz set to dominate US biosimilars market

Home/Reports | Posted 31/05/2013

A new report released by Thomson Reuters on 14 May 2013 identifies Amgen, Hospira and Sandoz as having the greatest potential to dominate the early stages of the biosimilars market in the US.