WHERE is Europe now regarding biosimilar medicines?
Biosimilar medicines are now a reality in the European Union. The necessary legal framework for biosimilar medicines has been solidly established in the EU and the first biosimilar medicines were approved by the European Commission in April 2006, with the endorsement that each of them “has been compared to and matches the reference medicine […] in terms of quality (how it is made), safety (for example the side effects that can occur when receiving treatment are similar), and effectiveness.” Guidance on risk management systems has also been developed which assures safe market entry and post-marketing monitoring of these medicines. In addition, a legal framework has been in place since 30 October 2005, which allows the performance of tests and trials in view of obtaining authorisation for a biosimilar medicine in the European Union without breaching patent law. This will facilitate the development of biosimilar medicines on the European territory.
Biosimilar medicines are now a reality in the European Union. The necessary legal framework for biosimilar medicines has been solidly established in the EU and the first biosimilar medicines were approved by the European Commission in April 2006, with the endorsement that each of them “has been compared to and matches the reference medicine […] in terms of quality (how it is made), safety (for example the side effects that can occur when receiving treatment are similar), and effectiveness.” Guidance on risk management systems has also been developed which assures safe market entry and post-marketing monitoring of these medicines. In addition, a legal framework has been in place since 30 October 2005, which allows the performance of tests and trials in view of obtaining authorisation for a biosimilar medicine in the European Union without breaching patent law. This will facilitate the development of biosimilar medicines on the European territory.
