This video explains innovator biologics and biosimilars.
Biologics are very specific, highly effective medicines that improve health outcomes in
many complex conditions, such as Crohn’s disease, ulcerative colitis, diabetes, rheumatoid
arthritis, cancer, osteoporosis, psoriasis, HIV, multiple sclerosis, growth deficiencies, and more
Biosimilars are products that are similar to an innovator biologic, but not identical.
We’ll come back to that, but first, let’s cover some background information.
We are all familiar with medicines in pill form, known as small molecule; they fill pharmacy shelves.
They have simple molecular structures and each medicine’s formula is relatively simple
to produce and copy.
Once a patent expires, other companies can make a copy and sell it as a generic version,
which will have the exact same active, chemically-derived ingredient as the innovator.
These brands, and their generic copies, are considered bioequivalent because the generic
medications are following the simple chemical recipe of the innovator drug, providing bioequivalent
levels of the drug in the body.
Pharmacists often substitute a small molecule with its generic, as long as there is no specific
medical reason to use the brand version.
An example of small molecule medicine is acetylsalicylic acid, or ASA, known by its brand name,
Aspirin®, but widely available as a generic.
By comparison, biologics are very large, intricate molecules, produced in living cells, from
highly specialized ingredients using a complex, biotechnology process, which is integral to
creating the final product.
It is impossible to produce an exact copy.
An innovator biologic is an original brand product.
Manufacturers must prove the medicine’s quality, safety, and efficacy and thoroughly
document its components and processes.
They also conduct numerous clinical trials treating patients who have the specific diseases
for which they seek treatment approval, known as an indication.
Health Canada then approves the product for each indication for which the manufacturer
has submitted solid evidence.
The brand has patent protection for a limited period of time.
We have been using biologic medicines for more than two hundred years, initially in
the form of rudimentary vaccines for smallpox as far back as 1796.
Another significant and widely used biologic medicine came from Canada in 1921, when Drs.
Banting and Best extracted the hormone insulin from pigs for use in humans to treat diabetes,
a previously fatal disease.
Biologics have diversified into very sophisticated medicines that continue to significantly improve
health outcomes for patients in many disease areas.
Examples of biologics include hormones, blood products, cytokines, growth factors, vaccines,
gene and cellular therapies, fusion proteins, and monoclonal antibodies.
Patients receive biologics by injection or infusion and cannot take them orally, since
the body will inactivate them during digestion.
Because biologics are proteins, the body can develop antibodies to them over time, which
can affect how well they work.
This immune response, or immunogenicity, might increase when switching from one biologic
to another or back again, and is a strong reason for a discussion with your health care
professional before switching among biologic products.
Now, let’s talk about biosimilars.
As with small molecules, once a patent expires, it is legal for other manufacturers to create
a biosimilar.
However, in the case of biologics, the innovator company is not obliged to share its patented
manufacturing processes and since there is inherent variability in a live biological
system, an identical copy is not possible for an innovator biologic or biosimilar.
No biosimilar will be deemed identical to its reference originator biologic.
With the biologic recipe’s complexity, biosimilar drugs are not generic.
Health Canada only approves biosimilars for marketing in Canada when the manufacturer
demonstrates that their product is of similar quality, safety, and efficacy to the original
reference drug.
However, as with innovator products, minor differences in production can lead to differences
in clinical activity and side effects, which might not become apparent until the product
is in widespread use.
There could be many different biosimilars all referencing one innovator medicine, and
each would have different biologic material and manufacturing processes, similar to the
innovator biologic, but not to each other.
Health Canada regulates biosimilars as new drugs by comparison with an innovator reference
product previously authorized and marketed in Canada.
Decisions regarding interchangeability and substitutability of products rest with the
various provincial and territorial drug regulatory bodies.
As the federal authority, Health Canada states that biosimilars are not generic biologics.
Health Canada also makes decisions to approve some biosimilars to treat conditions for which
the innovator biologic has approval, through educated assumptions by extrapolating scientific
evidence.
This includes a demonstration of comparability between a biosimilar and its reference biologic
with detailed understanding of the drug, the nature of the disease, and the patient population.
Therefore, a biosimilar might have an indication to treat a specific disease without testing
in that disease, and some biosimilars will not have the full array of indications as
the original reference product.
The cost of pharmaceuticals, particularly biologics, is an important consideration as
experts look at ways to make pharmaceutical care sustainable.
Because they are complex and have revolutionized the treatment for many diseases, biologic
medicines are costly and consume a large portion of public and private drug spending.
In most cases, biosimilars are less costly than the original biologic, due to extrapolating
scientific evidence performed by the innovator, which leads to lower development costs for
the biosimilar.
Treatment options are very important for patients who have serious health conditions.
With appropriate regulations in place around approval, advertising, and post-market monitoring,
as well as private and public insurance coverage, products that demonstrate a safe and effective
track record offer new treatment options for patients.
Biosimilars provide additional, lower-cost options for patients who are newly-prescribed biologics.
Prescribing medicines to treat chronic conditions should remain a decision between patients
and their physicians, and should not occur for purely financial reasons.
On behalf of the Gastrointestinal Society, I’m Dr. James Gray.
For up-to-date information about biologics and biosimilars in Canada, go to www.badgut.org/biosimilars