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More capacity needed in clinical trial review for national approval of biosimilars

The need for National Regulatory Authorities to build capacity in clinical trials review, and for WHO to continue monitoring regulatory procedures for the evaluation of biosimilars were among the main recommendations of a workshop to discuss the implementation of WHO guidelines on evaluating biosimilars in Seoul, Republic of Korea, 24–26 August 2010.

WHO guidelines on biosimilars: case studies and discussion highlights

The experiences and progress of different countries in implementing WHO guidelines on evaluating biosimilars were the focus of a workshop hosted jointly by WHO and Korea Food and Drug Administration (KFDA).

Global generics markets predicted to grow to US$221 billion by 2016

The global markets for generic drugs will continue to grow despite cost reduction measures from governments and healthcare payers in many markets.

Biosimilars marketed in Europe

Europe was the first region to approve and introduce biosimilars into the market back in 2006, and now in 2012 the continent is the largest biosimilars market in the world, with 14 biosimilars approved by EMA.

Biosimilars use in Europe

A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration process were issued in 2006. However, acceptance and use of biosimilars within Europe varies by country.

Oncologists inconsistent in how they judge value of high-cost cancer drugs

A survey of oncologists in Canada and the US has shown that physicians are inconsistent when deciding how long an expensive new cancer therapy should extend a person’s life before the cost of the therapy is justified. The results of the survey also showed the benefit that oncologists demand from new treatments in terms of length of survival does not necessarily increase according to the price of the treatment [1].

AARP report highlights importance of generics

According to a report issued on 6 March 2012 by AARP (formerly the American Association of Retired Persons) the prices of drugs used most widely by older Americans rose by nearly 26% from 2005 to 2009 or in other words nearly twice the rate of inflation.

UK gets value for money for its medicines

A UK Department of Health (DoH) report confirms that the voluntary pricing agreement between the DoH and the pharmaceutical industry is working and that medicines are good value for money for the National Health Service (NHS).

Early warning system for drug shortages in the US

In response to the record high numbers of drug shortages in the US [1] the IMS Institute for Healthcare Informatics (IMS Institute) has published a list of recommendations consisting of an ‘early warning system’ for drug shortages [2].

Volume and sales of drugs on the shortages list in the US

Despite record numbers of drug shortages being reported in the US [1], on the whole, over the past five years the supply of these drugs to healthcare providers–hospitals, clinics, pharmacies–has increased, according to a new report published by IMS Institute for Healthcare Informatics [2].