Subsequent entry biologics

General information about biosimilars

What are biosimilar?

A biosimilar is a biologic product that enters the Canadian market subsequent to a reference biologic drug and has a demonstrated similarity to this reference. Biologics are a class of drugs derived from living organisms that are more variable and structurally complex than chemically synthesized drugs. The regulatory approval process for biosimilars therefore differs from that for generic drugs. In Canada, their approval is based not only on a demonstrated similarity between a biosimilar and its reference biologic in terms of biological and physicochemical factors, but also on a reduced set of clinical and non-clinical data in comparison to a brand name drug.

In other countries, biosimilars are called "follow-on biologics."

How does INESSS evaluate registration applications for biosimilar?

The evaluation process for an biosimilar registration application is the same as that for brand name drugs with a DIN. Therefore, the same items required for the evaluation of new drugs must be provided for INESSS to evaluate all the criteria set forth under the law, taking into account the special characteristics of this type of drug.

If biosimilar are registered on the lists of medications, does that mean these products are interchangeable?

No. The purpose of the List of Medications is not to determine that a given drug is interchangeable with other products registered on the list. Instead, it looks at the classification of drugs whose cost is covered by the public plan, as well as the price and pricing method adopted by the Régie de l’assurance maladie du Québec. Pharmacists must observe the laws governing professions in Quebec when substituting products and inform patients about their prescribed medication. According to Health Canada standards, biosimilars are essentially biologics that are similar to innovative biologics in terms of physico-chemical properties, biological activity, immunochemical properties, purity, impurities, contaminants and quantity. The authorization of SEBs relies in part on prior information regarding safety and efficacy that is deemed relevant due to the demonstration of similarity to the reference biologic drug.

If you are interested in learning more about biosimilars and the approval process in Canada, Health Canada has published a fact sheet on the topic as well as guidance for sponsors. The latter document is accompanied by questions and answers. You can consult them with the following links:

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