News
Free samples increase use of branded drugs
2014-12-25 The practice of giving free samples to physicians to give out to their patients increases the use of brand-name drugs, according to research published in… Read More »
Challenges for the regulation of biosimilars
2014-12-23 The European Medicines Agency (EMA) was the first agency to issue guidelines for the approval of biosimilars via an abbreviated registration process back in 2006.… Read More »
Cost-cutting in Europe may affect generics sustainability
2014-12-19 According to a presentation by Mr Victor Lino Mendonça, the continued focus on short-term cost containment measures may lead to an unsustainable market environment for… Read More »
Results of clinical trials in Europe to be made publicly available
2014-12-17 It will soon be the law in Europe for all clinical drug trials to be registered and the results reported on a publicly-accessible database. Members… Read More »
Positive impact of a value-based approach to health care
2014-12-15 A study into the use of value-based benefit design (VBBD) for members of an employee health benefits programme demonstrated that such a programme can have… Read More »
FDA releases bioequivalence guidance for 26 generics
2014-12-11 On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of… Read More »
Biosimilars knowledge gap needs addressing
2014-12-09 The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engage in reducing the knowledge gap about biosimilars. EGA… Read More »
Regulatory principles for biosimilar monoclonal antibodies
2014-12-05 It is sometimes argued that there is less clinical evidence for biosimilars. However, Tsiftsoglou and co-authors pointed out that European Medicines Agency (EMA) guidelines for… Read More »
Australian price cuts make PBS affordable
2014-12-03 The price cuts for 121 medicines supplied through Australia’s Pharmaceutical Benefits Scheme (PBS) have made the PBS sustainable, according to Medicines Australia, a group that… Read More »
Development of Iranian guidelines for ‘biogenerics’
2014-12-01 The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of… Read More »
