Notice to stakeholders: Release of guidance document: Information and submission requirements for biosimilar biologic drugs for the addition of an indication where there is no/minimal data required to accompany the submission

Health Canada (HC) is pleased to announce the release of the guidance document, Information and Submission Requirements for Biosimilar Biologic Drugs. Comments received from the consultation on the draft version of the guidance document were reviewed and considered in the finalization of this document. This will come into force 30 days from the date of this notice.

HC is applying the labelling-only fee and related timelines to the biosimilar submissions for the extension of indication(s) where there is no additional data requested and it is to align with indications of the innovator. Sponsors will be required to submit a Sponsor Attestation form in Module 1.2.3 Certification and Attestation Forms at the time of filing.

HC changes are to the excerpt below from the Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs:

2.4 Post-Market Requirements

2.4.2 Post-notice of compliance (NOC) proposed changes

There may be situations post-NOC where biosimilar sponsors seek authorization of indications held by the reference biologic drug authorized in Canada. A Supplemental New Drug Submission (SNDS) for a biosimilar that relies on the previously demonstrated similarity provided in the original biosimilar NDS may be considered by Health Canada on a case-by-case basis. If accepted for review, these submissions would generally be considered a labelling-only SNDS. Biosimilar sponsors should consult with BRDD for regulatory guidance for their specific SNDS.

Contact Information

Office of Business Integration
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Building #6, 100 Eglantine Driveway
Tunney's Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601B

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