News
FDA issues draft guidance on biosimilars labelling
2016-12-02 The US Food and Drug Administration (FDA) announced on 31 March 2016 that it had issued draft guidance for industry on labelling for biosimilars. The… Read More »
European regulatory pathways for biosimilars
2016-11-30 The European regulatory pathways for biosimilars were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the… Read More »
Impact of antidepressant generics in Europe
2016-11-28 Use of generic antidepressants may improve adherence and reduce the cost of pharmacotherapy for depression in European countries, according to a report by the Germany-based… Read More »
Biologicals: characteristics that make them unique and special
2016-11-25 The unique characteristics of biologicals were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad… Read More »
Impact of South Korea’s new drug–pricing policy on market competition
2016-11-23 In April 2012, the Korean Government implemented a new policy to try and make its multiple sourced (off-patent) market more competitive. Their objective was to… Read More »
How the biosimilars market is changing
2016-11-21 Access to high quality medicine at affordable prices without jeopardizing patients’ health is one of the key challenges in developed countries where rising life expectancy… Read More »
IPRF template for summary information for biosimilar reviews
2016-11-18 The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) has released a template for Public Assessment Summary Information for Biosimilar (PASIB). The… Read More »
Epoetin alfa biosimilar effective in treating anaemia
2016-11-16 Authors of a post-marketing study of the epoetin alfa biosimilar Retacrit say that the biosimilar is effective and well tolerated in treating chemotherapy-induced anaemia (CIA)… Read More »
Impact of breast cancer generics in Europe
2016-11-14 Breast cancer generics can increase patient adherence and reduce healthcare budgets for European countries, according to a report by the Germany-based Institute for Healthcare and… Read More »
Biosimilars: a new challenge in the current pharmacology
2016-11-11 In a review of biosimilars in rheumatology author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain discuss issues surrounding biosimilars*. The… Read More »