BIOSIMILARS

Track:
Legal/Transparency-Risk Assessment

Day & Time:
March 5, 4:00PM - 5:30PM

Session Number:
0304

Room Number:
E102

Type:
Session

Title:
BIOSIMILARS

Chair(s):
Christian Schneider, DrMed
Senior Medical Officer
Danish Health and Medicines Authority, Denmark

Description:
Genetically engineered proteinaceous macromolecules are required to pass through the centralised marketing authorisation procedure according to the Annex to Regulation (EU) 726/2004. The first growth hormones, epoetines, interferon’s, insulins and monocular antibodies are no longer covered by patent. They were authorised over 10 years ago. Generic companies therefore wish to conquer this market and obtain the necessary marketing authorisations – called Biosimilars, not biotech generics! The session summary will explain the requirements for marketing authorisations and Pharmacovigilance. An important subject is also the substitution of prescribed biosimilars by pharmacists. It is currently being discussed throughout Europe. The scientific experts will discuss this topic from a Pharmacovigilance perspective

Presentation(s) & Speaker(s):
Biologicals in Pharmacovigilance – Adverse Drug Reaction (ADR) reporting and traceability
Christian Schneider, DrMed
Senior Medical Officer
Danish Health and Medicines Authority, Denmark

Biosimilars: Robust pharmacovigilance principles and patient safety
Peter De Veene, MD
EU QPPV
Roche Products Ltd, United Kingdom

Biosimilar Industry’s Point of View
Pascale Burtin, MD,PhD
Head Clinical Develop. Biopharma
Sandoz International Gmbh, Germany