UMMS Affiliation

Department of Medicine, Division of Rheumatology

Publication Date


Document Type



*Biological Products; Canada; Drug Approval; Drug Industry


Complex Mixtures | Pharmacy Administration, Policy and Regulation


In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canada's specific requirements may not be widely understood by many Canadian stakeholders. The Summit provided an opportunity for education and dialog among physicians who prescribe biologics, provincial payers, and industry on the following topics: preclinical and clinical comparability studies; manufacturing and other product differences; extrapolation of indications; substitution and interchangeability of SEBs with reference biologic drugs in clinical practice; payers' current perspective; pharmacovigilance and naming. It is anticipated that the consensus reached at this meeting will further educate Canadian healthcare professionals, provincial payers, and insurers about the appropriate use of SEBs, and may be of general interest to others internationally. rights reserved.


Biosimilars, Subsequent entry biologics, Similar biological medicinal products, Follow-on protein products, Substitution, Interchangeability

DOI of Published Version



Biologicals. 2012 Nov;40(6):517-27. doi: 10.1016/j.biologicals.2012.09.010. Epub 2012 Oct 17. Link to article on publisher's site

Journal/Book/Conference Title

Biologicals : journal of the International Association of Biological Standardization

Related Resources

Link to Article in PubMed

PubMed ID


Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.