Diabetes Canada believes that the needs of patients must be at the centre of health policy decisions. Diabetes Canada also recognizes that health-care funding decisions are made in an environment of limited fiscal resources. Thus, there must be a balance to ensure that people with diabetes are supported to achieve their full health potential, in a cost-effective manner, with the goal to meet the many health needs of Canadians.
Biologics are drugs created using biologic processes in living cells and are generally administered as an injectable. They are made from living cells (human, animal, bacteria).
Biosimilars are similar to an original biologic drug, made by different manufacturers after the patent on the drug has expired. Biosimilars are sometimes mistakenly called "generic" versions of innovative biologics. Unlike generics, which are identical copies of chemically synthesized drugs, biosimilars are similar to, but not identical to the original innovator drug. This is due to the complexities of their manufacturing process, i.e. rather than being developed from chemistry, these complex medications are made from living organisms.
- recognizes that biosimilars offer additional treatment choices for some people living with diabetes, may lower costs for patients and insurers, and may increase access to needed medications for patients;
- believes that the decision to use a reference biologic or a biosimilar must be made jointly by patients living with diabetes and their health-care provider, and that patients should be provided with all relevant information to make an informed choice;
- recommends that a biosimilar should not be automatically considered as an appropriate substitute or interchangeable with its reference biologic given insufficient data to confirm equivalence;
- believes that patients should not be required to switch their treatment regimen, given the lack of information on the effect of switching from a reference biologic to a biosimilar;
- recommends that there be post-marketing surveillance and safety reporting for biosimilars to ensure information about effectiveness and side effects is collected in a consistent manner; and
- recommends that biosimilars have unique non-proprietary names to ensure clarity about the product being prescribed and administered. This will also ensure accurate attribution of side effects and effectiveness.
Diabetes Canada will:
- help inform people living with diabetes about reference biologics and biosimilars through patient information and other literature outputs describing the manufacturing control, quality assurance and safety of biosimilars and their comparability to the reference biologic; and
- continue to communicate the role of biosimilars for people living with diabetes to governments and insurers to provide input on the public policies that impact their use.
Background and rationale
Insulin is a lifesaving therapy for all people living with type 1 diabetes and for some who live with type 2 diabetes. Insulin helps to regulate blood sugar, and insulin products have been developed to have specific durations of action. Primarily produced by recombinant DNA technology, insulin preparations belong to a group of drugs known as 'biologic drugs' or 'biologics'. Biologic drugs are very complex proteins that can have a variety of functions that impact disease progression and health outcomes. Their exact characteristics and properties are highly dependent on the manufacturing process. Therefore, each biologic is unique.
There has been an increase in the availability of these sophisticated biologic products in Canada, which presents new treatment options for patients. However, the high cost of biologics has been a growing concern for patients, public and private insurance plans.
Recently, manufacturers have developed less expensive alternative products that are intended to replicate the original reference biologic drugs as closely as possible; these are called biosimilars. Because biologics are derived from living organisms, they are more variable and structurally complex than chemically synthesized drugs. Thus, the regulatory approval process for biosimilars differs from that for generic drugs. Biosimilars are defined by Health Canada to be "a biologic medication that enters the market subsequent to a version previously authorized in Canada" and which has "demonstrated similarity to a reference biologic drug". Health Canada also states that biosimilars "are new drugs that are not declared to be pharmaceutically or therapeutically equivalent with their reference products, and this should inform decisions regarding interchangeability and substitutability". Additionally, "Health Canada does not support automatic substitution of a biosimilar for its reference biologic drug and recommends that physicians make only well-informed decisions regarding therapeutic interchange."
Health Canada also states that "the demonstration of similarity does not signify that the quality attributes of the two products being compared are identical, but that they are highly similar with two consequences:
- that the existing knowledge of both products is sufficient to predict that any differences in quality attributes should have no adverse impact upon safety or efficacy of the biosimilar; and
- that non-clinical and clinical data previously generated with the reference biologic drug are relevant to the biosimilar."
Because of the high cost of biologic drugs, the cost reductions associated with biosimilars present an attractive alternative. However, there are insufficient long-term comparison data to demonstrate interchangeability or the impact of switching for patients stabilized on therapy. This statement holds true for insulin products. Additional information is required prior to evidence-based recommendations about the safety and/or harms associated with interchangeability or switching between reference biologic insulin and biosimilar insulin. These products can be considered for patients newly started on the biologic.
Given the fact that biosimilars are not identical to their reference products, it is important that prescribers and pharmacists are able to readily distinguish between the original reference biologic and the biosimilars on the basis of their names. A unique non-proprietary name will assist in the accurate prescribing and dispensing of biosimilars and will help with attributing any side effects to a specific product or manufacturer.
After approval of a biosimilar for a given disease, ongoing surveillance is needed to establish the long-term safety profile in the post-marketing phase. Appropriate strategies must be used to ensure adequate vigilance for biosimilars.
Diabetes Canada will review this policy statement to ensure that it continues to be accurate and reflect the most up-to-date evidence.
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