Biosimilar and

Interchangeable Products
Foundational Concepts
Level 1
Contents
• What is a Biological Product? • Practical Considerations for Using Biosimilars and
– What Is a Biological Product? Interchangeable Biosimilars
– What Is a Biosimilar? – Biologics Naming Convention
– What Is an Interchangeable Biosimilar Product?
– Prescribing Biosimilars and Interchangeable Biosimilars
• Approved Biosimilars and the US Health Care
Market – Biosimilar and Interchangeable Products in Primary Care
– The Promise of Biosimilars and Community Practice: Insulins
– Biosimilars and Interchangeable Biosimilar Product – The Purple Book
Availability
• Adoption of Biosimilars
• Inherent Variation in Biologics
– Adoption of Biosimilars and Interchangeable Biosimilars
– Biologics Contain Inherent Variation
– Role of Clinical Studies – Adoption of Biosimilars
• Differences Between Generics and Biosimilars – Formulary Coverage and Reimbursement for Biosimilars
– Biosimilars Are Not Generics • Resources
– Comparing and Contrasting Generics and Biosimilars
• Key Takeaways
• Biological Product Approval Pathway
• Knowledge Assessment
– Biological Product Development
– Analytical Studies Form the Foundation of the Biosimilar – Multiple Choice Questions
Application Pathway

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 What Is a Biological Product?

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What Is a Biological Product?
Biological products (also called biologics) are generally large, complex molecules that range in size and
complexity. Typically, they are produced in living systems (e.g., microorganisms, plant cells, animal cells)
using recombinant DNA technology. This presentation refers to reference products, biosimilar products
(also called biosimilars), and interchangeable biosimilar products (also called interchangeable
biosimilars).
Biologics, including biosimilar and
interchangeable biosimilars, can be used
to prevent, treat, or cure a range of
diseases and medical conditions. Many
types of biologics are approved for use in
the United States, including therapeutic
proteins; vaccines; blood, blood
components or derivatives; allergenic
products; and monoclonal antibodies.

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What Is a Biosimilar?
Compared to a reference product:
• A biosimilar has no clinically meaningful differences in terms of the safety, purity, and potency (i.e., safety and effectiveness).
• Biosimilars are made from the same types of sources, are administered the same way, and have the same strength, dosage, potential
treatment effects, and potential side effects as the reference product.
• All FDA-approved biosimilars undergo a rigorous evaluation to ensure they are as safe and effective as their reference products.

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What Is an Interchangeable
Biosimilar Product?
An interchangeable product is a biosimilar that may be substituted
for a reference product without the intervention of the prescribing
healthcare provider, depending on state pharmacy laws.

• FDA-approved interchangeable biosimilars can be expected to produce the

same clinical result as the reference product in any given patient, and the
risk in terms of safety or diminished efficacy of alternating or switching
between the interchangeable biosimilar and the reference product is not
greater than the risk of using the reference product without such alternation
or switch.
• Manufacturers generally conduct switching studies in which patients
alternate between the reference product and the interchangeable biosimilar
and compare them to patients who are just being treated with the reference
product and results must show no decrease in effectiveness or increase in
risk when switching.
• While this additional information helps FDA to determine if a biosimilar is
interchangeable with its reference product, this does not mean that an
interchangeable biosimilar is safer or more effective than other biosimilars.

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 Approved Biosimilars and
the US Health Care Market

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The Promise of Biosimilars

Biosimilars and interchangeable biosimilars may

offer significant benefits:
• Enable cost savings to the patient, payor, and the health
system through greater access to life-saving medicines.
• Provide more treatment options for patients and access to
innovative therapies.
• Support competition, which may drive innovation and
technological advancement among originator biologics.

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 Biosimilar and Interchangeable
Biosimilar Product Availability
The continued development and availability of biosimilar and interchangeable biosimilar products
presents a major opportunity for savings in the U.S. healthcare market, with some estimates projecting a
savings of $180 billion over the next five years as a result of biosimilars.1

The U.S. biologics

market has grown
an average of
12.5% annually 12
As of 2023, biosimilars
have been launched for
12 originator products
representing 14% of
biologics spending.
$180B
46% over the past five
years, and now Biosimilars are already in
Savings as a result of biosimilars are
projected to exceed $180 billion
between 2023 – 2027, representing a

30
comprises 46% of development for an four-fold increase from estimates of
total medicine additional 30 therapeutic the preceding five years.
spending. products without a currently
approved biosimilar or 694 Million Patient Days
interchangeable product.

Not all FDA-approved biosimilars will be available on the U.S. healthcare market due to multiple factors, such as ongoing patent
litigation, formulary availability, and exclusivity protections that delay market entry.

1 IQVIA (2023). Biosimilars in the United States 2023–2027: Competition, Savings, and Sustainability.

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Reference Products and Approved
Biosimilars as of May 2024 (53 total)

Note: Products with an asterisk have the 351(k) Interchangeable designation.

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 Inherent Variation in Biologics

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Biological Products Contain
Inherent Variation
Cells can make exact copies of the protein, but after the protein is made, other variations (e.g., add-ons and
changes) may occur, like the addition of sugar molecules or the modification of certain amino acids.

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Biological Product Lot-to-Lot
Variability
Because biologics are generally made in cells, there are
inherent variations that result from the manufacturing
process. Inherent variation may also exist within lots and
between different lots of reference products and biosimilars.
A lot of a reference product and biosimilar can contain
millions of slightly different versions of the same protein or
antibody.
• As part of the approval process for both reference products and
biosimilars, FDA assesses a biosimilar manufacturer’s strategy to
control for the pattern and degree of variations between different lots to
help ensure consistent safety and effectiveness.
• Manufacturers must demonstrate that their proposed biosimilar product
has similar variations compared to the reference product and that their
product has no clinically meaningful differences in terms of safety and
effectiveness. Compared to the reference product, the effect of the
biosimilar is the same, dosing is the same, and administration is the
same.

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Role of Clinical Studies

As a scientific matter, FDA expects:

• An adequate clinical PK comparison, and PD

comparison if relevant, between the proposed
biosimilar and reference product.
• An assessment of immunogenicity for the
proposed biosimilar product.
• A comparative clinical study in patients
can contribute to the totality of the evidence
supporting biosimilarity.

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 Difference Between
Generics and Biosimilars

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Biosimilars Are Not Generics
Biosimilars and generic drugs are both versions of original brand-name medicines that may offer patients
more affordable treatment options. There are, however, important differences:
• Generic drugs are usually chemically
synthesized while biological
products, including biosimilars, are
generally manufactured from living
sources.
• Because the active ingredients of
generic drugs generally are smaller
and simpler, they are usually easier
to copy.
• Biologics generally cannot be copied
exactly, because the product (e.g.,
monoclonal antibody) contains a mix
of many slight variations of a given
protein that occurs during its
production from living sources, which
introduces inherent variation.
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Comparing and Contrasting
Generics and Biosimilars
Biosimilars, including interchangeable biosimilars, and generic drugs are
both versions of brand-name medicines, which may offer more affordable
treatment options to patients. Examples of important differences between
biosimilars and generics are in the table below.
Generics Biosimilars
Typically manufactured through Typically manufactured from living sources.
chemical synthesis.
Generally smaller, simpler molecules. Generally larger, complex molecules.
Identical active ingredient between Inherent variability (i.e., small variations in
lots (i.e., no variation). protein molecules) exists from lot to lot.
The FDA assesses manufacturers’
strategies to control for variability to ensure
consistency in safety and effectiveness.

Must demonstrate active ingredient is Must demonstrate highly similar to the

the same as in the reference listed reference product with only minor
drug. differences allowed/expected in inactive
ingredients.
Must demonstrate bioequivalence to Must demonstrate no clinically meaningful
the reference listed drug. differences from the reference product.
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 Biological Product
Approval Pathways

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Biological Product Development
Development programs for a new biological product (reference product) and a biosimilar have different goals. The
goal of biosimilar development is not to independently establish the safety and effectiveness of the proposed
product, but to demonstrate that the proposed biosimilar is highly similar to and has no clinically meaningful
differences from the FDA-approved reference product. When seeking approval, this generally means that
manufacturers of biosimilars do not need to repeat expensive and lengthy clinical trials. This may potentially lead to
additional therapeutic options and reduced costs for patients.
For biosimilars:
• The analytical assessment serves as the
foundation for demonstrating biosimilarity. The
assessment compares multiple physicochemical
and functional attributes of the proposed biosimilar
and the reference product.
• Finally, manufacturers conduct comparative
clinical studies comparing the proposed biosimilar
to the reference product, which typically include
comparison of pharmacokinetics (PK),
pharmacodynamics (PD), and immunogenicity,
when applicable.

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Analytical Studies Form the Foundation
of the Biosimilar Application Pathway

Approval of a biosimilar is based on the totality of the evidence submitted by the applicant to provide an
overall assessment that the proposed product is biosimilar to the reference product. Analytical studies form
the foundation of the assessment and may be supported by clinical studies.
The nature and scope of clinical studies will depend on the extent of residual uncertainty about the product’s
biosimilarity, if any, after conducting structural and functional characterization studies comparing the biosimilar
to the reference product.

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 Practical Considerations for
Using Biosimilars and
Interchangeable Biosimilars

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Biologics Naming Conventions
Many biologics*, including reference, biosimilar, and interchangeable biosimilar products, are subject to
FDA’s naming policy.
• The naming convention is a combination of a nonproprietary core name and a unique, product-identifying 4-letter suffix to help
distinguish products.
• FDA adopted the naming convention to help with pharmacovigilance and safe use for all biologics and to help patients and
providers know which biologic medicine is being prescribed and dispensed.
• Health care professionals should include the 4-letter suffix when ordering, prescribing, dispensing, and in recordkeeping and
pharmacovigilance practices, including reporting adverse events to MedWatch, the FDA Safety Information and Adverse Event
Reporting Program.
• The biosimilar or interchangeable biosimilar will share the same core name as its reference product.

*Note: Some reference products approved prior to implementation of the naming convention may not have a suffix.

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Prescribing Biosimilar and
Interchangeable Biosimilars
• Health care professionals can prescribe biosimilars and interchangeable biosimilars by name, just as they would prescribe
other medications.
• Interchangeable biosimilars may be substituted for the reference product without the intervention of the prescribing health
care provider, subject to state laws. State laws that address substitution of biological products at the pharmacy vary;
therefore, it is important for prescribers and pharmacists to understand the pharmacy practices in their state.
• Health care providers do not need to wait for a biosimilar to be approved as an interchangeable product to prescribe it.
FDA does not approve a product as interchangeable unless a company specifically seeks an interchangeability
determination. Biosimilars are as safe and effective as the reference product to which they were compared.

Pharmacy-Level Substitution of Interchangeable Biosimilars

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The Purple Book
The Purple Book: Database of Licensed Biological Products is a user-friendly online database with information on all
FDA-approved biologics. It provides patients, payors, clinicians, and others with an accessible, easy-to-use online
search engine with information about FDA-approved biologics, including whether a specific biologic is a reference
product, biosimilar, or interchangeable biosimilar.

Features of the Purple Book

• Simple and advanced search options
• Auto-suggest search function
• Additional search filters
• Data download options
• Links to product labels (Drugs@FDA)
• Ability to show/hide sortable columns of information
• Ability to print or export search results
• Searchable glossary of terms
purplebooksearch.fda.gov

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 Adoption of Biosimilars

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Adoption of Biosimilar and
Interchangeable Biosimilar

Adoption of biosimilars and interchangeable biosimilars and increased access to important therapies in the United States
require not just the approval of these medicines by FDA and adoption by health care institutions (e.g., formulary inclusion,
payor coverage), they also require awareness and acceptance by patients and health care providers.

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Adoption of Biosimilars

• Patients seek information primarily from their health

care providers (e.g., doctors, nurses, physician
assistants, pharmacists) as trusted sources on the
safety and effectiveness of potential treatment
options.
• Understanding patients’ needs for information
related to biosimilars can support health care
providers as they have conversations about
biosimilars in the shared decision-making process.
• As the number of available biosimilar and
interchangeable products grow, providers will
increasingly encounter patients taking a biosimilar
product in primary care and community health
settings (e.g., patients taking insulin)
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Formulary Coverage and
Reimbursement for Biosimilars

While the FDA does not have a direct role in drug pricing, FDA supports a competitive marketplace for biologics,
including biosimilars and interchangeable biosimilars, to improve patient access to medicines and facilitate the reduction
of health care costs. FDA recognizes that coverage and reimbursement significantly impact the adoption of biosimilar
and interchangeable products and depend on many factors, such as insurance plans, formulary coverage, and an
adequate understanding of biosimilarity and the FDA’s approval standards. Understanding the impact on workflow and
patient acceptance, as well as cost and reimbursement issues, is also a factor. As more biosimilars and interchangeable
biosimilars enter the market, understanding of coding and payment rates is becoming increasingly important.

Resources on Coverage of Biosimilars and Interchangeable Biosimilars:

• Center for Medicare & Medicaid Services (CMS): Part B Biosimilar Biological Product Payment and Required
Modifiers
• US Commercial Health Plans: Plans vary on how particular biosimilars are covered. According to an analysis of
publicly available data on coverage decisions, U.S. commercial health plans only covered biosimilars as “preferred”
products in 14% of coverage decisions in 2019 (Chambers JD et al., 2020, JAMA)
• Payors: Biosimilars: Considerations for Payers (Smeeding J et al., 2019, P&T)
• States: State laws and legislation related to biologic medications and substitution of biosimilars (National Conference
of State Legislatures [NCSL])

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 Resources

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Resources
FDA Pages Additional Resources for Health Care Students
• Biosimilar materials • Resource Guide for Teaching Faculty - Insulins/Interchangeable
• Provider materials • Slide Decks (Levels 1 and 2): - Comparative Analytical Assessment
- Foundational Concepts - Quality Attributes
• Patient materials - Regulatory and Scientific Concepts - Labeling/Package Insert
• Purple Book • Case study (Levels 1 and 2): • Explanatory Videos (Level 2):
• Drugs@FDA (Drug Information) - What Is a Biosimilar? - Manufacturing and Inherent Variation
• Search page for FDA guidances - Biosimilars in Patient Care - Biosimilar Approval Process
• Advisory committee materials for - Interchangeable Biosimilars - Critical Quality Attributes
- Insulins/Interchangeable - Interchangeability
biosimilars
- Comparative Analytical Assessment
• Biosimilar approval process • Info sheets (Levels 1 and 2):
- Purple Book
information - Procedural Purple Book
- Biological Products, Biosimilar Products,
and Interchangeable Biosimilars - Totality of the Evidence
Products - Comparative Analytical Assessment
- Generics and Biosimilars • Discussion Questions (Levels 1 and 2)
- Manufacturing and Variation - Foundational Concepts
- Biosimilar Regulatory Approval Pathway - Regulatory and Scientific Concepts
- Variation in Biological Products • Exercises (Levels 1 and 2) Provided in the
- Comparative Clinical Studies Resource Guide for Teaching Faculty
- Prescribing Biosimilar Products and • Resources
Interchangeable Biosimilar Products
- Purple Book

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 Key Takeaways

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Key Takeaways
Potential impacts of
What is a Generics and Variation in biologics and Prescribing and
biosimilars in US
biosimilar? biosimilars safety of biosimilars substitution
health care
• Biosimilars are • Comparing biosimilars • Reference products and • Health care professionals • Biosimilars can offer
biological products to generics is a useful biosimilars are approved can prescribe biosimilars more treatment options
that are highly similar analogy at a high level, through different regulatory and interchangeable at potentially lower costs
to and have no but remember there pathways. biosimilars just as they than the reference
clinically meaningful are important • All biologics (both reference would prescribe other product.
differences from an differences. For products and biosimilars) medications. • Multiple factors drive
FDA-approved example: contain slight, natural • FDA-approved product availability on
reference product. • Generics generally variation as they are typically interchangeable biosimilars the market such as
are chemically manufactured from living may be substituted for the patents, exclusivity
synthesized and sources. reference product without protections, business
usually can be copied • Assessments are performed the intervention of the decisions by the
more easily. to compare the biosimilar to prescribing health care manufactures, and
• Biosimilars are more the reference product to provider, subject to state policies/coverage by
complex and cannot ensure that any inherent laws. payors.
be copied exactly. variability in the final product • Laws differ by state on • Health care leaders can
does not result in any biological product help educate
clinically meaningful substitution. stakeholders to
differences in terms of safety encourage biosimilar
and effectiveness. inclusion in formularies
and coverage by payors.

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 Knowledge Assessment

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Multiple Choice Questions – 1 of 11
Section: What is a biological product?
Q1: What is a biosimilar product?
A. A biosimilar is a biological product.
B. A biosimilar is highly similar to an FDA-approved biological product, also called the reference
product.
C. A biosimilar has no clinically meaningful differences from the reference product (i.e., patients
and providers can expect the same benefits and risks as the reference product).
D. *All of the above.
E. None of the above.

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Multiple Choice Questions – 2 of 11
Section: What is a biological product?
Q2: Which of the following statements about interchangeable biosimilar products are true?
A. All interchangeable biosimilar products are biosimilar products.
B. All biosimilar products are interchangeable products.
C. To be approved as an interchangeable biosimilar product, biosimilar manufacturers must demonstrate that
the risk in terms of safety or diminished efficacy of alternating or switching between the interchangeable
biosimilar product and the reference product is not greater than the risk of using the reference product alone.
D. *A and C.
E. B and C.

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Multiple Choice Questions – 3 of 11
Section: What is a biological product?
Q3. A biosimilar product…
A. Is a biological product that is highly similar to an FDA-approved biological product, called the reference
product.
B. Has no clinically meaningful differences from the reference product (i.e., patients and providers can expect the
same benefits and risks as the reference product).
C. Has the same dosage, route of administration, potential benefits and risks, safety, and efficacy as the
reference product.
D. A and C.
E. *All of the above.

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Multiple Choice Questions – 4 of 11
Section: What is a biological product?
Q4. An interchangeable biosimilar product…
A. Is a biosimilar product.
B. Can be expected to produce the same clinical result in patients as the reference product.
C. Has the same safety and efficacy as the reference product when alternated with the reference product.
D. May be substituted without the intervention of a medical prescriber, subject to state laws.
E. *All of the above.

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Multiple Choice Questions – 5 of 11
Section: Approved Biosimilars and the US Health Care Market
Q5. Biosimilar products play a role in the US health care market by:
A. Increasing competition thereby potentially decreasing cost of biological products.
B. Decreasing access.
C. Expanding treatment options.
D. *A and C.
E. A and B.

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Multiple Choice Questions – 6 of 11
Section: Difference Between Generics and Biosimilar Products
Q6: Which of the following statement(s) is true regarding biosimilar products and generic drugs?
A. Biosimilar products generally are large complex molecules that are manufactured from living cells while most
generic products are small molecules that are typically manufactured chemically.
B. Biosimilars are made up of identical molecules with no variation.
C. Manufacturers must demonstrate that generics are highly similar and have no clinically meaningful
differences from the reference product.
D. The active ingredient in generics is the same as the active ingredient in the reference listed drug.
E. *A and D.

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Multiple Choice Questions – 7 of 11
Section: Biological Product Approval Pathway
Q7: Which statement(s) is false regarding the biosimilar 351(k) approval process?
A. *Biosimilar products and reference products are approved through the same regulatory approval pathway by
FDA.
B. Reference products are approved in a stand-alone application through the 351(a) regulatory approval
pathway by FDA whereas biosimilar products are approved through a different, abbreviated regulatory
approval pathway by FDA.
C. The abbreviated regulatory approval pathway for biosimilar products can be less expensive and less time-
consuming than the pathway for reference products in part because biosimilar manufacturers can rely on
FDA’s finding of safety and effectiveness for the reference product.
D. FDA ensures that biosimilar manufacturers demonstrate that the biosimilar product is highly similar to and has
no clinically meaningful differences from the reference product in terms of safety, purity, and potency.
E. B and C.

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Multiple Choice Questions – 8 of 11
Section: Biological Product Approval Pathway
Q8. Which of the following is true regarding the biosimilar 351(k) approval process?
A. Biosimilar manufacturers must demonstrate that biosimilar products are highly similar to and have no clinically
meaningful differences from the reference product.
B. Comprehensive comparative analytical studies form the foundation of the data package submitted by
biosimilar manufacturers.
C. FDA generally expects additional comparative clinical pharmacological data (pharmacokinetics and
pharmacodynamics) and comparative clinical efficacy studies (human studies) for a proposed biosimilar
product based on the totality of the evidence presented by the biosimilar manufacturer for a particular
indication.
D. A and B.
E. *All of the above.

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Multiple Choice Questions – 9 of 11
Section: Biologics Naming System
Q9: Which statement is true about the naming convention for biological products?
A. Many biological products and all biosimilar products use a nonproprietary name that consists of a core name
plus a unique, product-identifying 4-letter suffix that is devoid of clinical or pharmacological meaning.
B. The naming convention is intended to help patients and medical providers track which biological product is
being administered (reference product vs. biosimilar product vs. interchangeable biosimilar product).
C. The naming convention aids in postmarket surveillance.
D. *A, B, and C.
E. A and C.

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Multiple Choice Questions – 10 of 11
Section: Prescribing and Substitution
Q10. Which statement is true about prescribing biosimilar products and interchangeable biosimilar
products?
A. Biosimilar products and interchangeable biosimilar products can be used in patients who have previously been
treated with the reference product (i.e., treatment-experienced), as well as in patients who have not previously
been treated with the reference product (i.e., treatment-naïve).
B. Interchangeable biosimilar products may be substituted without the intervention of the healthcare provider,
subject to state laws.
C. State laws that address substitution of biological products at the pharmacy level vary; therefore, it is important
for prescribers and pharmacists to understand the pharmacy practices in their state.
D. *All of the above.
E. None of the above.

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Multiple Choice Questions – 11 of 11
Section: Adoption of Biosimilars
Q11. Adoption of biosimilar products in the US health care market may be affected by which of the
following factors, among others:
A. Cost to manufacture individual biosimilar products is different for different products.
B. Biosimilar coverage is dependent on individual payors and type of insurance. Different payors (e.g., insurance
companies, Medicare, Medicaid) may or may not have biosimilar products on their formularies. Therefore, not
all biosimilar products may be covered by payors or insurance types.
C. Even though a biosimilar product may be approved for use in the United States by FDA, it may not be
marketed because of existing patents on the reference product, among other reasons.
D. *All of the above.
E. None of the above.

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