1. Promoting patient-centred healthcare around the world Regulation of Biosimilars Jo Harkness

2. Promoting patient-centred healthcare around the world Regulatory Status In 2004 two directives were introduced by the European commission These provided a regulatory framework in the EU There is a clearly defined regulatory framework in the EU

3. Promoting patient-centred healthcare around the world Approval process The company must provide a comprehensive file of tests undertaken In the laboratory In patients Must demonstrate that the biosimilar is safe, effective and comparable to the original innovator drug (reference product)

4. Promoting patient-centred healthcare around the world Additional tests required Determined by the history of the drug More complex biosimilars will require more additional testing Drugs with long history and therefore experience (e.g. insulin) will require fewer additional tests than newer drugs

5. Promoting patient-centred healthcare around the world Slide Title Framework for case-by-case approach to assessing biosimilars, taking into account current scientific knowledge Centralised Procedure mandatory for biopharmaceutical and biosimilars More emphasis on manufacturing processes than for generics More emphasis on pharmacovigilance than for generics

6. Promoting patient-centred healthcare around the world Guidelines to date: Somatotropins Recombinant erythropoietins Recombinant human Insulin Recombinant granulocyte-Colony Stimulating Factor Recombinant α-Interferons Guideline on Immunogenicity Assessment Please see EMEA website for details (reference numbers on your handouts)