Biosimilar biologic drugs

A biosimilar biologic drug, or biosimilar, is a biologic drug demonstrated to be similar to a brand name drug already authorized for sale (known as the reference biologic drug). Biosimilars were previously known in Canada as subsequent entry biologics (SEBs). Biosimilars may enter the market after the expiry of reference biologic drug patents and data protections.

Biosimilars are regulated as new drugs under the Food and Drugs Act and the Food and Drug Regulations. To obtain authorization as a biosimilar, the drug manufacturer must provide information to Health Canada to show that the biosimilar and the reference biologic drug are similar and that there are no clinically meaningful differences in terms of safety and efficacy between them. Health Canada's decision to authorize a biosimilar for sale is based upon a benefit/risk assessment after considering all of the data submitted by the manufacturer. Health Canada's rigorous standards for authorization mean that patients and health care providers can rely upon the quality, safety, and efficacy of a biosimilar, just as for any biologic drug.

Visit the links below for more information on the regulation of biosimilars.

Fact Sheet

The Fact Sheet: Biosimilar biologic drugs in Canada provides information about biosimilars and their regulation in Canada.

Guidance documents

The Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs communicates the regulatory framework for biosimilars and is intended to help manufacturers follow the laws and regulations governing the authorization of biosimilars in Canada.

The Notice to Stakeholders Release of the Revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs outlines key revisions in the 2016 guidance document.

The Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations provides information about the administration of C.08.004.1 of the Food and Drug Regulations

The Guidance Document: Patented Medicines (Notice of Compliance) Regulations provides information about the administration of the Patented Medicines (Notice of Compliance) Regulations.

The Policy Statement: Clarifying the appropriate regulatory pathway for subsequent entry low molecular weight heparins describes Health Canada's approach to regulating low molecular weight heparins (LMWHs) containing medicinal products claiming to be similar to another heparin already on the market.

The Product Monograph Template – Schedule D – Biosimilar Biologic Drug is intended to guide sponsors in the preparation of biosimilar product monographs.

Naming of Biologic Drugs

Notice to Stakeholders - Policy Statement on the Naming of Biologic Drugs

What We Heard Report – Stakeholder Consultation on the Naming of Biologic Drugs

Scientific Advice

The Notice - Subsequent Entry Biologics Scientific Advice Meeting Pilot provides information on a three year pilot to complement the biosimilar development process.

Stakeholder Engagement

Health Canada’s 2017 Biosimilars Workshop: Summary Report

Additional information

Health Canada's Drug Product Database contains product specific information including product monographs for drugs authorized in Canada.

Regulatory Decision Summaries (RDSs) briefly explain Health Canada's decision for drugs including biosimilars.

Summary Basis of Decision (SBD) documents explain in further detail why Health Canada authorized certain drugs for sale in Canada. SBD documents are available for biosimilars authorized in Canada.

Submissions Under Review (SUR) lists certain drug submissions currently under review by Health Canada.

The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products.

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