Illegal marketing of biologics and biosimilars
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Biologic and biosimilar drugs
Biologic drugs:
- are often made using biotechnology
- come from living organisms or their cells
- are listed in Schedule D of the Food and Drugs Act
- are usually larger and more complex than a pharmaceutical drug
A biosimilar biologic drug, also known as biosimilar, is:
- not the same as a generic drug
- a drug shown to be highly similar with no clinically meaningful differences to a biologic drug that was already authorized for sale
A biosimilar and its reference biologic drug can be shown to be similar, but not identical, due to their:
- complexity
- molecular size
- natural variability
Requirements to advertise biologic and biosimilar drugs in Canada
Biologic and biosimilar drugs are strictly regulated in Canada under the:
- Food and Drugs Act
- Food and Drug Regulations
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations
The Terms of Market Authorization (TMA):
- consist of the product monograph
- set out the biologic and biosimilar drugs’ intended use(s) as authorized by Health Canada
Vaccines are biologic drugs but follow the marketing rules for natural health products and non-prescription drugs.
Promotional claims must not be directly or indirectly inconsistent with the scope of the product monograph.
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What to watch for in biologic drug advertising
Watch for biologic drug advertising that:
- claims or insinuates that since Heath Canada did not issue bioequivalency between the biologic drug and the biosimilar that:
- the biosimilar is significantly different than the biologic drug
- switching to a biosimilar as determined by the health care provider poses a significant risk to the patient
- uses fear tactics that are not evidence-based to discourage biosimilar use
What to watch for in biosimilar advertising
An advertisement for a biosimilar is considered misleading and in violation of federal legislation if it claims:
- to be identical to the reference biologic drug
- pharmaceutical equivalence, bioequivalence or clinical equivalence with the reference biologic drug
How health care providers can help stop illegal marketing
We need your help to stop the illegal marketing of biologics and biosimilars.