Generics medicines: a tradition of quality, safety & efficacy.
Biosimilar Medicines
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Competition and Affordability in Biopharmaceuticals
The next generation of more affordable biological medicines is no longer a distant dream, but a present-day reality in European healthcare.
Biosimilar Medicines: Access to Medicines and EU Competitiveness
Europe’s generic medicines companies possess the scientific knowledge and technical experience to produce safe and effective biosimilar pharmaceuticals, which are medicines derived from biotechnology.
And the legislative framework exists in Europe for the European Medicines Agency (EMEA) to evaluate the quality, safety and efficacy of these new biological medicines. Indeed, since 2006 the European Commission has authorised several biosimilar medicines in Europe, declaring 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.”
Europe’s healthcare systems are eager for the cost relief and the increased patient access to the life enhancing treatments that biosimilar products will bring.
Further information about this important new type of medicinal treatment is available at the links below.
| FAQ on Biosimilars
| EGA Handbook on Biosimilar Medicines
| Position Papers |
| Scientific Articles & Presentations
| Legal & Regulatory Framework |