Overview:
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
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
