Subsequent Entry Biologics in Canada

The term Subsequent-Entry Biologic (SEB) is used by Health Canada to describe "a biologic product that is similar to and would enter the market subsequent to an approved innovator biologic product." The agency is currently considering the regulatory process by which such products would be granted a marketing licence in Canada.

BIOTECanada supports the creation of a transparent and predictable regulatory pathway for the regulation of SEBs that incorporates processes and requirements that protect the safety of patients and preserves intellectual property incentives for the continued introduction of innovative biologics for the benefit of Canadian patients.

BIOTECanada members have developed a set of principles that the biotechnology industry believes should guide the introduction and regulation of SEBs in the Canadian marketplace.

Health Canada Releases Updated Guidance to Sponsors for Subsequent-Entry Biologics

SEB Guidance Document (March 8, 2010)

Data Protection Guidance (March 8, 2010)

PM(NOC) Guidance (March 8, 2010)

Canadian Roundtable on Clinical Considerations for Subsequent-Entry Biologics: Key Learning Points for Physicians, Pharmacists and Patients

BIOTECanada Positions and Presentations

News Library

• Obama Pushes More Competition on Biologic Drugs, The New York Times (September 19, 2011)
• China and India Making Inroads in Biotech Drugs The New York Times (September 18, 2011)
• Biosimilars are back - Or are they?, Scientific American (August 8, 2011)
• Race to copy biotech drugs creates odd bedfellows, Reuters Article (June 22, 2011)

Publications Library

• Biosimilars of Biological Drug Therapies, Biosimilars Review 2011
• Developing the Nation's Biosimilars Program (August 2011)
• French health regulatory agency status and advice report on biosimilars (July 2011)
• An overview of US and EU pathways for biosimilars review/approval, Published Article from Arthritis Research & Therapy
  

Health Canada Resources