HOW is the EGA involved in biosimilar medicines?
The EGA, a European trade association representing the generic and biosimilar medicines industry, takes an active interest in all issues related to medicinal products, including medicines derived from biotechnology. Some member companies of the EGA are indeed biotechnology companies, or companies with biotechnology business units. The EGA has been particularly involved in working toward the establishment of a legal framework and a regulatory pathway to allow the development and approval of biosimilar medicines in Europe. This will allow patients to gain access to more affordable biotechnology medicines.
The EGA, a European trade association representing the generic and biosimilar medicines industry, takes an active interest in all issues related to medicinal products, including medicines derived from biotechnology. Several member companies of the EGA are biotechnology companies or companies with biotechnology business units. The EGA was particularly involved in the establishment of a legal framework and a regulatory pathway to allow the development and approval of biosimilar medicines in Europe. At present, the EGA continues to support companies developing biosimilar products, by ensuring that full market access is assured, and that the evolving regulatory landscape for biosimilars in Europe remains favourable. This will allow patients to gain access to more affordable high quality biopharmaceuticals [1]. Since biosimilars have now been in use safely in the European Union for several years, we can assert today that EGA members have extensive clinical experience with biosimilars. Our m
