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