News
EU guidelines for nanosimilars
2013-11-19 Last update: 5 November 2013 The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency… Read More »
WHO naming of biosimilars
2013-11-14 The World Health Organization (WHO) has proposed a system of naming for biosimilars, which has been commended by some groups, but criticized by others. The… Read More »
The future of nanomedicines – nanosimilars
2013-11-12 First there were generics, then came biosimilars and soon the European Medicines Agency (EMA) is anticipating the first nanosimilars, or similar versions of originator nanomedicines.… Read More »
California governor vetoes biosimilars bill
2013-11-08 On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598, a bill that some believed would have impeded access to biosimilars.… Read More »
Regulation of similar biotherapeutic products in Latin America
2013-11-06 Regulation of similar biotherapeutic products (SBP) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars,… Read More »
Generics may be allowed to change drug labelling
2013-11-04 FDA has proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers. Under current regulations… Read More »
Use of brand-name drugs increasing healthcare costs in US
2013-11-01 Patients with diabetes who are covered by the US healthcare insurance Medicare are two to three times more likely to use expensive brand-name drugs compared… Read More »
Biosimilar competition in Europe
2013-10-30 A study of five European Union (EU) countries has revealed that Germany provides the most favourable environment for uptake of biosimilars. The study, which was… Read More »
Patient care threatened by cancer drug shortages
2013-10-28 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… Read More »
Generics combo non-inferior to treatment with Enbrel
2013-10-25 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… Read More »
