Immunome Research
Open Access

Subsequent entry biologic (biosimilar) monoclonal antibodies in Canada: A review of key regulatory issues and lessons learned

2^nd International Conference on Antibodies and Therapeutics

July 11-12, 2016 Philadelphia, USA

Bradley Scott, Wang J and Klein A

Biologics and Genetic Therapies Directorate, Canada

Posters & Accepted Abstracts: Immunome Res

Abstract :

Subsequent Entry Biologics (SEBs) or biosimilars are more commonly known as biotherapeutic products that enter the market subsequent to a previously authorized biotherapeutic to which they have been proven to be highly similar. Monoclonal antibodies represent the most complex of these molecules manufactured to date. For these products, similarity should be rigorously proven from physicochemical and biological perspectives and should be supported by similarity in clinical pharmacology, clinical efficacy, safety and immunogenicity. Health Canada authorized its first monoclonal antibody biosimilars in 2014 and has since begun reviewing other proposed biosimilars mAbs for market authorization. This increased activity coincides with the recent expiration of patents and exclusivities for many of the first innovative monoclonal antibody products. The speaker will discuss the approach that Health Canada takes to the review and authorization of monoclonal antibody biosimilars, lessons learned since the publication of the guidance document Guidance for sponsors: Information and submission requirements for subsequent entry biologics (SEBs) in 2010 and recent efforts to update the guidance based on our experiences with biosimilar submissions. Key issues such as the use of a nonnational reference product, immunogenicity and extrapolation will be highlighted.

Biography :

Email: bradley.scott@hc-sc.gc.ca