EMA Biosimilar Workshop: 5.2. Pharmacovigilance (PV) EMA, 24 Oct - PowerPoint PPT Presentation

EMA Biosimilar Workshop: 5.2. Pharmacovigilance (PV) EMA, 24 Oct 2011, London Mark McCamish, MD, PhD Global Head Development Sandoz Biopharmaceuticals

Biosimilars are Comparable to Originators Comparability at all levels:  Product attributes overlapping with reference  Goal: As close to the reference as the reference is to itself considering manufacturing changes  Innovative clinical trial designs  All essentials learned about originator product  PV approach consistent with originators

PV Requirements Same as all Biologics Follow existing/new EU PV Legislation  Same PV rules as applies to all biologics whether novel or biosimilar  Unique post-marketing PV requirements could apply to manufacturing changes and biosimilars  REMS/RMPs consistent with originator  Rare events documented in accordance with existing PV requirements

Traceability/Identification Traceability same as any biologic  Clear identification of biosimilar via approved trade name  ADR reporting: name and batch number  Traced via controlled systems/processes  No new INN needed for biosimilars

Overarching Themes Overarching Themes  Same PV rules as applies to all biologics including manufacturing changes of originators and biosimilars  Follow existing/new EU PV legislation Joint EMA/EBE/EGA Experts round-table on Biological Medicinal Product and Pharamacovigilance: 17 February 2012