30 March 2011
11.30 – 13.00
Room E1
Austria Center Vienna
Vienna, Austria

Chair and Moderator
Jos Kosterink, PharmD, PhD
University Medical Center Groningen
Groningen, the Netherlands

Faculty
Jens Kampmann, MD, DMSc
Bispebjerg Hospital
Copenhagen, Denmark

Håkan Mellstedt, MD, PhD
Karolinska Institute
Stockholm, Sweden

Meenu Wadhwa, PhD
National Institute for Biological Standards and Control
Hertfordshire, United Kingdom

This educational activity is specifically designed for pharmacists and other healthcare professionals involved and/or interested in the use of biologic and biosimilar medicines.

At this meeting expert pharmacists, physicians, and scientists will address a number of issues surrounding the use of biosimilar medicinal products in Europe. The recent emergence and approval of biosimilars has resulted in numerous questions regarding the utilization of these products, including which indications they should be used for, how to handle resultant immunogenicity, how to trace their use and associated adverse events, and whether a biosimilar should be automatically substituted for the originator drug.

Upon completion of this educational activity, participants should be able to:

• Differentiate biosimilar drugs from the originator drugs
• Discuss the role of international nonproprietary names (INNs), including how the use of identical INNs for biosimilars and originator drugs impacts traceability
• Explain factors related to immunogenicity, assessment of immunogenicity, and potential consequences of immunogenicity
• Review clinical safety and efficacy, as well as risk minimization strategies
• Describe extrapolation and analyze potential situations in which extrapolation may be appropriate and determine those situations in which extrapolation across indications would be inappropriate
• Provide accurate and appropriate counsel as part of the treatment team

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by PIM for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.