Europe Trip

Biosimilars in the US, Europe and Canada – Webinar by GlobalCompliancePanel

January 13, 2014 | Comments Off on Biosimilars in the US, Europe and Canada – Webinar by GlobalCompliancePanel

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

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.

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

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