Follow-on, Oh Canada

  • by: |
  • 03/24/2008
Our regulatory cousins to the north have begun the process of creating a biosimilar regulatory framework.

Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.

Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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