Current Status of biosimilars in US, Europe and Canada

Current Status of biosimilars in US, Europe and Canada


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About The Event


Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.

Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability study ongoing in Denmark and new legislation in France using public policy to drive use of biosimilars. We will address upcoming patent losses, and what is known about current development of new biosimilars.

Why should you Attend: Understanding this fast developing area is critical. How will approvals be handled. Will indications be able to be bridged from a clinical study in one therapeutic area to another. Will interchangeability be recognized? How are some products / companies being successful? These are all questions in this complex landscape. We will address the current thinking on each and provide an update in terms of what is being done by whom in terms of development in this area.

Areas Covered in the Session:

  • Biosimilar legislation in the US
  • Purple Book
  • Marketing applications filed using the biosimilar route or other routes
  • Interchangeability requirements
  • Status of subsequent entry biologics in Canada
  • Review of two products that have been successful in Canada by two different routes
  • Existing guidelines in Europe
  • Review of approvals in Europe
  • Interchangeability for infliximab in Denmark
  • Public policy driving biosimilars in France
  • Ongoing development work on biosimilars worldwide

Who Will Benefit:
  • CEO
  • Marketing director
  • New Business Director
  • Regulatory Affairs Director
  • Research Director
  • Clinical Director
  • Nonclinical Director


Speaker Profile
Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies. Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005). Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs. 

Adam Fleaming
Phone: +1-800-447-9407
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