This document sets out to describe the effects on price, volume and market share following the arrival and presence of biosimilar competition in the European Economic Area (EEA). The document consists of a set of indicators and guidance on how to interpret these indicators. It has been prepared as a set of indicators to monitor the impact of biosimilars in the European markets. It was prepared by IMS Health at the request of the European Commission services with initial contributions from EFPIA, EGA, and EuropaBio.
EMA has a central role in setting the rules for biosimilar submissions, approving applications, establishing approved indications and monitoring adverse events, and if necessary issue safety warning. We have when appropriate quoted their information and statements.
This first report will be based on full year 2014 data; the objective thereafter is to annually publish the previous year’s updated indicators.
To read The Impact of Biosimilar Competition full report, please click here.
To read The Impact of Biosimilar Competition: Reading Guide, please click here.
To read The Impact of Biosimilar Competition: Five Observations by IMS Health, please click here.
To consult the infographics, please click here.
To view the full report, please click here.
To view the full report, please click here.
A study about the future sustainability of the biosimilar medicines market undertaken by GfK Market Access on behalf of the European Biosimilars Group, now the Biosimilar Medicines Group.
According to the European Commission (hereinafter ‘EC’) of the European Union (hereinafter ‘EU’), the threat to public health and safety from falsified medicinal products is on the rise:
‘Falsified medicines […] are a major threat to public health and safety. As falsifications become more sophisticated, the risk of falsified medicines reaching patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level.’1 In order to control and combat the threat mentioned, the EC has introduced new legislation to put in place preventive measures to improve the protection of the public. The basis for this new legislation was defined in the Directive 2011/62/EU2 (hereinafter: ‘Directive’), amending Directive 2001/83/EC3 (hereinafter: ‘the original Directive’).
Following adoption by the EC and the European Parliament, the new legislation on falsified medicinal products was published on 1 July 2011 in the Official Journal of the EU. This new legislation came into force on 2 January 2013 and introduces new harmonised EU-wide measures to ensure that medicinal products are safe and that the trade in medicines is rigorously controlled. In order to expand on this basis, the EU has launched a concept paper and set out public consultations4 on a number of different topics with the EU member states. The responses from these public consultations will be used as discussion points when the EC prepares the delegated acts, which serve as a minimum requirement for adoption of the Directive into the national laws and regulations of the EU member states.
The remainder of this chapter will set out the objective of this report and the approach taken in developing this report.
To view the full report, please click here.
To view the web version, please click here.
To view the full report, please click here.
