Advent of Oncology Monoclonal Antibody Biosimilars - A European Perspective Online
WebcastFaculty
OVERVIEW
Advent of Oncology Monoclonal Antibody Biosimilars - A European Perspective Online is organized by Physicians Education Resource, LLC (PER) and will be held during Nov 30, 2017 - Nov 30, 2018.
The target audience for this medical event is directed toward oncology healthcare practitioners based outside of the United States, including medical oncologists, surgical oncologists, radiation oncologists, and pharmacists involved or interested in the treatment of cancers. A broader audience of European pharmacists and physicians are also invited to participate.
Course Description :
The European Medicines Agency (EMA) has approved more than 37 biosimilars since developing guidelines and recommendations for evaluation of these agents. As biologic products lose patent exclusivity, and more biosimilar monoclonal antibodies receive regulatory approval, it will be necessary for healthcare providers to understand the key concepts and issues involved in biosimilar development so they can make informed decisions when adopting these agents into their clinical practice. This is especially critical because multiple biosimilars of the same product are likely to become available. It is also important to be clear about whether a specific product has been evaluated through a rigorous evaluation procedure, based on the criteria defined in the EMA biosimilar guidelines, and for prescribers to understand what happens when a biosimilar receives a designation of “interchangeable” with the originator and when substitution may occur, as these designations/policies may impact patient outcomes.
Learning Objectives :
At the conclusion of this activity, you should be better prepared to:
• Explain the importance of analytical studies in development and regulatory approval of biosimilars
• Describe the concepts of immunogenicity and extrapolation of indications based on evaluation of the totality of the evidence and mechanism of action rationale
• Appraise the importance of pharmacoeconomics and access to biological oncology medicines in Europe
• Discuss the potential clinician-, nurse-, pharmacist-, and patient-specific issues relating to the suboptimal use of biosimilars and strategies to mitigate them
• Summarize current and emerging data on oncology monoclonal antibody biosimilars and their potential to enable optimal combination therapy
Additional details will be posted as soon as they are available.
The target audience for this medical event is directed toward oncology healthcare practitioners based outside of the United States, including medical oncologists, surgical oncologists, radiation oncologists, and pharmacists involved or interested in the treatment of cancers. A broader audience of European pharmacists and physicians are also invited to participate.
Course Description :
The European Medicines Agency (EMA) has approved more than 37 biosimilars since developing guidelines and recommendations for evaluation of these agents. As biologic products lose patent exclusivity, and more biosimilar monoclonal antibodies receive regulatory approval, it will be necessary for healthcare providers to understand the key concepts and issues involved in biosimilar development so they can make informed decisions when adopting these agents into their clinical practice. This is especially critical because multiple biosimilars of the same product are likely to become available. It is also important to be clear about whether a specific product has been evaluated through a rigorous evaluation procedure, based on the criteria defined in the EMA biosimilar guidelines, and for prescribers to understand what happens when a biosimilar receives a designation of “interchangeable” with the originator and when substitution may occur, as these designations/policies may impact patient outcomes.
Learning Objectives :
At the conclusion of this activity, you should be better prepared to:
• Explain the importance of analytical studies in development and regulatory approval of biosimilars
• Describe the concepts of immunogenicity and extrapolation of indications based on evaluation of the totality of the evidence and mechanism of action rationale
• Appraise the importance of pharmacoeconomics and access to biological oncology medicines in Europe
• Discuss the potential clinician-, nurse-, pharmacist-, and patient-specific issues relating to the suboptimal use of biosimilars and strategies to mitigate them
• Summarize current and emerging data on oncology monoclonal antibody biosimilars and their potential to enable optimal combination therapy
Additional details will be posted as soon as they are available.
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