Biosimilar medicines
are here in Europe as a result of the regulatory pathway opened up through
the EU Pharma Review. The guidelines are established, and registrations
have been received
and approved. The biosimlar medicines recently introduced in the EU
are exected to generate savings of over €1.6 billion in Europe.
Today at the 6th EGA Symposium on Biosimilar Medicines, Greg Perry congratulated the industry and EU medicines regulatory authorities today for further consolidating and developing the EU’s rigorously scientific “biosimilar thinking” during 2007.
• Julie Maréchal, Sr Manager Regulatory Affairs, EGA
EU Commission Survey & EMEA Inspectorate Action Plan (API GMP) |
EU Legislative Proposal | Revision of the EU GMP Guide | Impact of ICH Quality Related Topics More...
“The EGA is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality
affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector.”