What
are generic drugs?
A generic drug is the brand equivalent, or bio-equivalent
to a brand name drug in all of the following: dosage form,
safety, strength, route of administration, quality, performance
characteristics and intended use. Although generic drugs
must be pharmacologically equivalent to their branded counterparts,
they are typically sold at a lower price than the branded
formulation.
Why
is there a difference in cost between branded and generic
drugs?
New drugs, like other new products, are typically developed
under patent protection. The patent protects the original
investment made in developing the drug by giving that company
exclusive rights to sell and/or market the drug during the
lifetime of the patent. When patents or other periods of
exclusivity expire, manufacturers can make and sell the
Health Canada approved generic versions. The Abbreviated
New Drug Submission (ANDS) process does not require the
drug sponsor to repeat costly animal and clinical research
on ingredients or dosage forms already approved for safety
and effectiveness.
Generic manufacturers have plenty of competition, but with
lower R&D costs and considerably lower expenses in advertising
and marketing, generic drugs are priced significantly lower
than the branded drug, in most cases.
Are
generic drugs as safe and effective as branded drugs?
Health Canada regulates all generic products under strict
safety and efficacy guidelines, requiring the same testing
as the branded product to ensure that the generic version
is interchangeable with its branded counterpart.
For both brand name and generic drugs, Health Canada works
with pharmaceutical companies to assure that all drugs marketed
in Canada meet specifications for identity, strength, quality,
purity and potency. In approving a generic drug product,
Health Canada requires the same tests and procedures to
assure that the generic is interchangeable with the brand
name drug under all approved indications and conditions
of use.
Do
generics differ at all from brands?
Generics may differ slightly from brands as far as inactive
ingredients are concerned. As long as bioequivalence is
attained, Health Canada allows generics to use different
inactive ingredients, such as fillers and dyes, than those
used in the brand. These inactive ingredients however, do
not affect the safety or performance of the generic formulation.
Is
the quality level the same?
Health Canada continuously ensures that pharmaceutical
companies test the quality of products currently on the
market, and periodically inspects the manufacturing facilities
of generic pharmaceutical companies for quality control.
Health professionals and consumers have the assurance that
Health Canada approved generic drugs have met the same rigid
standards as the innovator or branded formulation. To gain
Health Canada approval, a generic drug must meet all of
the following criteria:
 |
Contain "the same"
active ingredients as the innovator drug, (inactive
ingredients may vary); |
|
Be the same in strength, dosage
form, and route of administration; |
|
Have the same use indications;
|
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Be therapeutically equivalent;
|
|
Meet the requirements for
identity, strength, purity, and quality and be manufactured
under the same strict standards of Health Canada’s
Good Manufacturing Practice regulations required for
innovator drugs. |
| |
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