New online healthcare professional handbook on biosimilar biologic drugs

Health Canada has developed a new online handbook designed to inform and educate healthcare professionals, including doctors, nurses and pharmacists, on biosimilar biologic drugs in Canada. The handbook was developed in consultation with a working group composed of experts from Health Canada and various health professional associations. The handbook provides objective, evidence-based information on the regulation and scientific basis for the authorization of biosimilars by Health Canada.The website handbook describes the distinct nature of biosimilars compared to generic drugs and data requirements for the authorization of biosimilars. The website is organized into the following specific chapters: About biosimilars; Data requirements; Immunogenicity; Authorization of biosimilars; Monitoring; Access to biosimilars; Appendices; and Case studies. A biosimilar is a biologic drug that's highly similar to a biologic drug (the reference biologic drug or originator product) already authorized for sale in Canada. Unlike generic drugs, biosimilars are not identical to their reference biologic drug, because they're isolated from or manufactured in living organisms. However, they have been demonstrated to have no clinically meaningful differences in efficacy and safety compared to the reference biologic drug.Health Canada authorizes biosimilars according to the same regulatory standards of quality (chemistry and manufacturing), safety and efficacy that apply to all biologic drugs authorized in Canada.A biologic drug is authorized on the basis of quality, nonclinical and clinical data. Authorization requires demonstration of similarity via a complete new drug submission, using studies that compare the biosimilar to its reference biologic drug. Required studies include comparative physicochemical, structural and functional properties, and may also include comparative nonclinical, pharmacokinetic/pharmacodynamic and clinical studies as needed. Once similarity is established, the evidence used to support the authorization of the reference biologic drug is applied to the biosimilar's authorization.Health Canada grants the biosimilar’s indications based on the efficacy and safety of the reference biologic drug. The biosimilar may be granted all or only some of the indications based on a number of criteria. Health Canada points out that authorization of a biosimilar is not a declaration of equivalence to the reference biologic drug. This is because the biosimilar is highly similar but is not identical to its reference biologic drug. Only provinces and territories can deem that two products are interchangeable, according to their own rules and regulations.Once marketed, Health Canada monitors the safety of each biosimilar using the same pharmacovigilance activities used for all drugs.Health Canada acknowledges that although the new handbook was developed in consultation with a working group composed of experts from Health Canada and external healthcare professionals representing a range of professional associations, the views expressed in the handbook are those of Health Canada and do not necessarily reflect the views of the external healthcare professionals who were part of the working group.References1. MedEffect Canada. Handbook for healthcare professionals on biosimilar biologic drugs. Health Product InfoWatch: December 2023. (accessed January 2, 2024).2. Health Canada. Handbook for health care professionals on biosimilar biologic drugs: Access to biosimilars and communicating with patients. (accessed January 2, 2024).

New online healthcare professional handbook on biosimilar biologic drugs

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