GlobalCompliancePanel, Online Training, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
2013-12-12
Overview: The approach to biosimilars in the US, Europe and Canada has differed significantly. Trying to develop and market a biosimilar involves careful consideration. Among the issues to consider carefully are the Reference Product, requirements for chemical/biological comparison of the Reference Product to the Test Product, the nature of the bridging clinical study that has to be done, whether any nonclinical studies need to be conducted, what immunological characterization will need to be done. The process for getting an approval of a biosimilar in these three jurisdictions is also different and will be reviewed.
The presentation will review biosimilars approved to date and any associated post marketing requirements. Finally, interchangeability and reimbursement of biosimilars will be discussed.
Why Should You Attend : Understanding the approval process for biosimilars is difficult and confusing. The first stumbling block is the choice of the Reference Product and how transferable clinical studies are across jurisdictions. Understanding how to put an R&D program together varies across jurisdictions and trying to synergize these requirements can be difficult. Understand what companies/products have been successful. Once approved, understand whether these products can be reimbursed and interchanged, and therefore what the marketing possibilities are.
Areas Covered in the Session: Choice of Reference Product in the US, EU and Canada
Characterization of the Test Biosimilar product to the Reference Product
Nonclinical testing requirements
Clinical bridging studies
Approval of multiple indications based on clinical study of one indication
Immunological characterization
Process for approval
Precedents for approval
Interchangeability
Reimbursement
Who Will Benefit:
Regulatory Managers, Directors
Business Development Staff
R&D Personnel
Nonclinical Personnel
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Invited Speakers:
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Anne Tomalin Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs. Anne also founded CanReg Inc. in September 1996. CanReg was acquired by OptumInsight in December 2009. Prior to founding CanReg, Anne was employed for 20 years with Searle Canada, A Unit of Monsanto Canada Inc. as Business Unit Director. Responsibilities in the last several years at Searle included regulatory affairs, provincial government, reimbursement strategies, managed care, customer interface, legal and information services. Prior to joining Searle, Anne was employed by Hoffmann-LaRoche Limited for three years. Prior to Roche, Anne was employed for three years by Wyeth Ltd.
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Registration:
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Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
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