petition and Innovation Act passed by the U.S. Congress
in 2009. This legislation created a new way for biologic
medications, such as insulin, to be approved and sold in
the United States. To understand how this happens, it’s
important to understand some definitions.
- Biological product: A category of medications that are
generally made of large, complex molecules. Because
these products contain such complex molecules, it can-
not be guaranteed that all of the products are exactly the
same when looking at the molecular structure. - Reference product: A product approved by the FDA after
a thorough assessment to make sure it is both safe and
effective. When a biosimilar product is going through
the FDA review process, this is the product to which the
biosimilar product is compared. - Biosimilar product: A biological product that is highly
similar to and considered to have no difference that would
change what you expect from the reference product. - Generic drug product: A medication that has an active
drug ingredient exactly the same as the brand-name
medication previously approved by the FDA.
FDA approval process
For approval as a biosimilar product, manufacturers must
show the FDA that the product is comparable to the reference
product in several ways, including 1) purity of the product,
2) chemical identity and 3) how it works inside the body.
Studies have to show the FDA that there are no differences in
the products in how safe the product is or how well it works.
While biosimilars may be thought of as “generics” of
their reference products, this is not technically true. Both
generic drugs and biosimilar products are able to go through
a shorter approval process with the FDA. However, generic
drugs approved by the FDA are required to have the same
active ingredients and no difference in how it works inside
the body when compared to their brand-name counterparts.
Biosimilar insulin in the United States
In other parts of the world, including Europe and Asia,
insulins have been approved through the biosimilar
pathway. However, in the U.S., these products have gone
through a different FDA approval process and are called a
“follow-on product.” FDA rule changes scheduled to take
place in early 2020 will merge these two processes so that
a biological product approved as a drug will be classified
the same as other licensed biological products.
There are currently two follow-on insulin products avail-
able for use in the United States. The first, in 2015, was
a long-acting insulin, Eli Lilly and Company’s Basaglar®
insulin glargine injection, with the reference product
being Sanofi-Aventis’ Lantus® insulin glargine injection.
Additional long-acting injection products have either
received tentative approval from the FDA or have been
approved and distributed in other countries but have not
yet become available in the U.S. In December of 2017,
the FDA approved the first rapid-acting follow-on insulin
product, Sanofi-Aventis’ Admelog® insulin lispro injection,
reference product Eli Lilly’s Humalog® insulin lispro injec-
tion. Eli Lilly has announced they will offer a lower-priced
generic of their rapid-acting insulin Humalog®. Since it
will be available from the same manufacturer, there will
be no difference in the insulin molecule.Diabetes clinical implications
You should expect no difference between taking a biosimi-
lar or its reference product in how safe it is, how well it
works or your health outcomes. Due to small differences
in the manufacturing process, rare but serious reactions
of the immune system may occur when switching to a
biosimilar or follow-on product.Pharmacy rules
Each state has different laws about whether a pharmacy is
able to substitute a biosimilar for its reference product. Each
state’s legislation addresses key biosimilar principles, includ-
ing how the products are FDA approved, if a prescriber
decision is necessary for substitution, how a prescriber
must be communicated with, how the patient is notified,
what records must be kept and if cost affects the decision.Decreasing costs
A major contributor to increasing costs of prescriptions has
been biologic products, insulin, cancer medications and
monoclonal antibodies that are used for a variety of condi-
tions, such as rheumatoid arthritis and Crohn’s disease. If you
take insulin, your out-of-pocket costs may have also increased.
Similar to generic drugs, biosimilar products may allow
access to treatment at lower costs due to less in research
costs and competition between manufacturers to drive
price decreases. Other countries have seen treatment costs
decrease by up to 40 percent due to biosimilar products.
It is still unknown if the biosimilar pathway will reduce
costs of insulin in the United States; however, a recent
study estimated that biosimilar products including insulins
will decrease spending on biologic drugs by $54 billion
between 2017 and 2026 in the United States.Conclusion
The Biologics Price Competition and Innovation Act has
allowed for biosimilar products to enter the drug market
in the United States. These products are not the same as
a generic drug but do offer similar benefits in terms of
potentially decreasing the cost of medications and patient
access. The approval of biosimilar or follow-on products
with the FDA gives you and your diabetes care team assur-
ance these products are safe and effective. Kristina Naseman is a doctor of pharmacy and master licensed
diabetes educator at UK HealthCare for the inpatient diabetes service
team, Barnstable Brown Diabetes Center and Maternal Fetal Medicine.
Laura Hieronymus is a doctor of nursing practice, master licensed
diabetes educator and associate director of education and quality
services at the UK HealthCare Barnstable Brown Diabetes Center.
Both are at the University of Kentucky in Lexington, Kentucky.
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