Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biological product, known as the reference product. An interchangeable biosimilar is expected to produce the same clinical result as the reference product. Biosimilars work in the same way as the reference product through the same mechanism of action. Unlike generics, biosimilars are not necessarily identical due to differences in living organisms used to produce them. As biosimilars gain approval, they have the potential to increase treatment options for patients and lower healthcare costs.

1. Biological Products
 What are Biosimilars
 Difference to Generics
 What can they do for us in
the future

2. Biological Products
 Many of today’s important medications are biological
products.
 Biological products are made from living organisms.
 The material they are made from can come from many
sources, including humans, animals and
microorganisms such as bacteria or yeast.
 Biological products are manufactured through
biotechnology, derived from natural sources or, in some
cases, produced synthetically.

3. Biological Products...
 Biological products are among the medications used to
treat conditions such as
rheumatoid arthritis,
anemia,
low white blood cell counts,
inflammatory bowel disease,
skin conditions such as psoriasis and various forms
of cancer.

4.  Most biological products are more complex in
structure and have larger molecules or mixtures
of molecules (however can consist of relatively
small molecules such as human insulin or
erythropoietin, or complex molecules such as
monoclonal antibodies) than conventional drugs
(e.g. Aspirin, also called small molecule drugs).

5. Biological Products...
 Conventional drugs are made of pure chemical
substances and their structures can be identified.
 Most biologics, however, are complex mixtures
that are more difficult to identify or
characterize and to manufacture.

6. Biosimilars
What are biosimilar and interchangeable biological
products?
 There are two new types of biological products: biosimilar
and interchangeable.
 Biosimilars are a type of biological product that are licensed
(approved) by FDA or another health authority (HA, e.g. EMA)
because they are highly similar to an already FDA or another HA
approved biological product, known as the biological
reference product (reference product), and have been shown
to have no clinically meaningful differences from the
reference product.

7. Biosimilars...
 An interchangeable biological product, in addition to
meeting the biosimilarity standard, is expected to
produce the same clinical result as the reference
product in any given patient.

8. Will biosimilars work in the same way as the biological
reference product they were compared to?
 Yes, biosimilars have no clinically meaningful
differences in terms of safety and effectiveness from
the reference product they were compared to.
 In addition, a biosimilar needs to have the same mechanism
of action as the reference product it was compared to, which
means it will work in the same way as the reference product.

9. …
 The FDA or another HA will only approve a
biosimilar product if it has the same mechanism
of action, route of administration, dosage form,
and strength as the reference product.
 Additionally, a biosimilar can only be approved for the
indications and conditions of use that have been
previously approved for the reference product.

10. Are biosimilars generic versions of biological products?
 No, generic drugs are copies of brand-name
drugs, have the same active ingredient, and are the
same as those brand name drugs in dosage form,
safety, strength, route of administration, quality,
performance characteristics and intended use.
 That means the brand-name and the generic are
bioequivalent.

12.  Biosimilars are highly similar to the reference
product they were compared to, but have
allowable differences because they are made
from living organisms.
 Biosimilars also have no clinically meaningful
differences in terms of safety, purity, and potency
from the reference product.

13. What are Generic Drugs?
 A generic drug is identical--or bioequivalent--to a brand
name drug in dosage form, safety, strength, route of
administration, quality, performance characteristics and
intended use.
 Although generic drugs are chemically identical to their
branded counterparts, they are typically sold at substantial
discounts from the branded price.
 Generic drugs save consumers, hospitals and health insurance
systems quite a lot of money.

14. WHY can they be cheaper
 New drugs, like other new products, are developed
under patent protection.
 The patent protects the investment in the drug's
development by giving the company the sole right to
sell the drug while the patent is in effect.
 When patents or other periods of exclusivity expire,
manufacturers can apply to the FDA or another HA to
sell generic versions.

15.  The 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.
 This applies to drugs first marketed after 1962 (US
market).

16. Examples for Biosimilars Approved by FDA:
 Inflectra is biosimilar to Remicade (infliximab).
 It’s approved for multiple conditions, including:
Crohn’s disease
Ulcerative colitis
Rheumatoid arthritis
Ankylosing spondylitis
Psoriatic arthritis
Plaque psoriasis

17. Examples for Biosimilars
 Zarxio (filgastrim-sndz) is biosimilar to Neupogen
 It‘s approved for multiple conditions, including:
Cancer
Hematopoietic Stem Cell Transplantation
Neutropenia

18. Examples for Biosimilars
 Erelzi is biosimilar to Enbrel (Etanercept)
 It‘s approved for multiple conditions, including:
 Autoimmune diseases such as
rheumatoid arthritis,
plaque psoriasis,
psoriatic arthritis,
juvenile idiopathic arthritis (JIA),
ankylosing spondylitis(AS)

19. Biologics versus Biosimilars
 Biologics are different from conventional medications.
 Conventional medications—drugs—are generally made
from chemicals or chemically synthesized, and
therefore their structure can be relatively easily
defined.
 Unlike conventional medications, biologics can’t be
made by following a chemical “recipe.”

20.  Biologics come from living organisms that are
variable in nature.
 Because of that, developing biologics is a far
more complex process than manufacturing drugs.
 Currently, biologics are among the fastest
growing segments of the prescription product
market.

21. Increased Options, Lower Costs?
 Biosimilars are likely to create greater competition in
the medical marketplace.
 This could not only increase treatment options for
patients but also lead to less expensive alternatives
to comparable products.
 With an increasing number of biosimilars on the
market, consumers may expect to get equally safe
and effective treatment, but at lower costs.