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What is a biosimilar?
The current biologics and biosimilars landscape in Canada
November 12, 2015
Karen A. Burke, Ph.D.
Director, Regulatory Affairs, Amgen Canada Inc.
© 2015 Amgen Inc. All rights reserved.
Safe Harbor Statement
This presentation contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number
of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than
statements of historical fact, are statements that could be deemed forward-looking statements, including statements about estimates of revenues,
operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices,
customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking
statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange
Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing this information as of October 22, 2013 and expressly disclaims any duty to
update information contained in this presentation.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company’s results may be
affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments
(domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or
foreign) and difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by
third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation
affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development,
usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by
domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our
products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. If we fail
to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant
sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications
may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing
capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and
product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the
discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from
concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a
commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers.
Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase
our common stock.
What we’re going to cover today…
• Biologics: a quick overview
• Biosimilars / Subsequent Entry Biologics (SEBs)
– Growing interest in biosimilars
– What we can learn from Europe
– Health Canada perspective
– What’s in a name?
– Considerations on pricing
– Patient safety/patient choice
• Discussion
© 2015 Amgen Inc. All rights reserved.
Biologics are…
used to treat serious
diseases, including cancer,
blood conditions,
auto-immune disorders and
neurological disorders
Biologics are…
typically made in living
organisms, mainly by
genetically engineering DNA
Biologics are…
far more complex than
traditional chemical
medicines (“small
molecules”)
Biologics are…
large molecules
The basics of biologics
And…
manufacturing matters
© 2015 Amgen Inc. All rights reserved.
© 2015 Amgen Inc. All rights reserved.
Why does manufacturing matter?
• Biologic medicines are typically made in living organisms
mainly by genetically engineering DNA
• The DNA is introduced into cells, and a particular cell line
is selected for expansion
• The cell line is expanded in bioreactors
• The biologic drug is then isolated and purified using highly
sophisticated and controlled technology
© 2015 Amgen Inc. All rights reserved.
Original
Biologic Biosimilars
What are biosimilars?
© 2015 Amgen Inc. All rights reserved.
Biosimilars are approved
based, in part, on the
studies done with the
reference product
Biosimilars are similar to the
reference product, but they
are virtually never the same
Biosimilars are copies of
biologic drugs developed
after the patent has expired
on an originator drug
(the ‘reference product’)
Seemingly minor differences can lead to
products with different characteristics
Burgundy
France
Santa Ynez
California
“Burgundian”
Earthy
“Californian”
Fruity
Temperate climate
Frequent rainfall
Intermittent sunshine
Hot
Rare rainfall
Constant sunshine
Pinot Noir
SEBs are similar…But not identical…
© 2015 Amgen Inc. All rights reserved.
SEBs are similar…
Why is there growing interest in
biosimilars?
© 2015 Amgen Inc. All rights reserved.
Biologics represent
approximately 1% of claims2
Biologic sales are growing
at 14% per year vs. 4% for
others
17% of drug spend is
allocated to biologics
It is estimated that by 2020,
the US, EU, Japan and
Canada will spend over $1
trillion on medicines1
Patent expiry could offer
opportunities for drug spend
savings
Biosimilar landscape in Europe
Biosimilar medicines have been available in the
European Union (EU) for several years
The necessary legal framework for biosimilar
medicines was adopted in the EU in 20051
The first biosimilar medicines (human growth
factor) were approved by the European
Commission in April 20062
© 2015 Amgen Inc. All rights reserved.
While not predictive of the future, the EU
biosimilars experience is informative
 Because biosimilars are not
generics, the market has not
reacted in a typical generic
fashion
 ESA biosimilars have captured
about 17% of the total EU
market by volume, and GCSF
biosimilars about 35%
 Originator products continue to
be prescribed and utilized for
years after biosimilars entry
© 2015 Amgen Inc. All rights reserved.
Legend:
ESA (Nephrology)
ESA (Oncology)
ESA Average of Nephrology & Oncology
GCSF
ESA - Erythropoiesis-Stimulating Agent
GCSF - Granulocyte Colony Stimulating Factor
Canada’s biosimilar landscape
In 2015, Health Canada approved a biosimilar insulin. More biosimilars are anticipated
to become available in Canada over the next few years.
In 2014, Health Canada approved Celltrion’s Remsima™ and Inflectra™. Both are
biosimilar versions of Remicade® and are both named infliximab.
Health Canada’s guidance on biosimilars was issued in 2010
In 2009, Health Canada approved Sandoz’ file for for Omnitrope™ - a recombinant
human growth hormone
© 2015 Amgen Inc. All rights reserved.
Health Canada’s position on SEBs
© 2015 Amgen Inc. All rights reserved.
Biosimilars are not
‘GENERIC’ BIOLOGICS
Health Canada does not support
automatic substitution
© 2015 Amgen Inc. All rights reserved.
Important: the approvals for the biosimilar(s)may
not be identical to the originator
• In approving Remsima®/Inflectra®, Health Canada did not
grant all indications held by the originator Remicade®
© 2015 Amgen Inc. All rights reserved.
Remicade® Remsima® and
Inflectra®
Indications RA, JIA, AS, PsA, PsO,
adult Crohn’s, pediatric
Crohns, fistulising
Crohn’s, adult ulcerative
colitis, pediatric
ulcerative colitis
RA, PsA, AS, PsO
What’s in a name?
Crestor® (rosuvastatin)
Remicade® (infliximab)
• INNs are managed by The World Health Organization (WHO)
• For small molecules, the same INN is given to both the original “brand” product
and the generic versions, because the active ingredients are identical ).
WHO
© 2015 Amgen Inc. All rights reserved.
BRAND NAME
INTERNATIONAL
NONPROPRIETARY NAME, INN
As biosimilars are not identical to the originator, they should have distinguishable
names (brand and INNs)
WHO’s biological qualifier
An INN proposal
– The WHO’s draft proposal for naming was released in July 2014
– That biosimilars be named using the current INN system, adding a
unique identification code (Biological Qualifier), which is to be a four-
letter code at the end of the drug name in order to distinguish the
biosimilar drug from the biologic
– The four-letter code will be assigned at random
– Final proposal pending
© 2015 Amgen Inc. All rights reserved.
WHO policy on biosimilar naming is not yet agreed, nor have
Health Canada or FDA taken a firm decision
Drug 1
Drug 2
Drug 3
Drug 4
and
brand name
Taking a closer look at why a
distinguishable name is important
If a prescription is
written with
INN
Patient could receive
Patient will receive
Removing uncertainty
© 2015 Amgen Inc. All rights reserved.
In the absence of a distinguishable INN, biologics prescriptions should include both INN
and brand name
Reporting adverse events: the importance of traceability
for patients and prescribers
It is unclear which
medicine should be
linked to the
adverse event
Pharmacist dispenses an
one of many biologics
with same INN
Physician
prescribes by
brand name
and INN
Pharmacist dispenses
stated brand or contacts
physician to agree change
Patient may have received
one biosimilar, followed by
another on the next
dispensing
In the event of an AE,
reporter knows exactly
which brand the patient
was dispensed
Physicians know
which drugs are
linked to adverse
events
Physician
prescribes by
INN only
If AE occurs
If AE occurs
INN only
Brand and INN
© 2015 Amgen Inc. All rights reserved.
In the absence of unique
identifiers for all biologics,
prescribing by brand name and
INN supports accurate
dispensing and correct
identification of the brand in
case of adverse events
Considerations on pricing
• Unlike for generic small molecules, biosimilar manufacturers have to
appropriately invest in clinical development, manufacturing and post-
approval safety monitoring programs similar to that of innovators1,2
• Because of this development investment, cost savings achievable for
biosimilars may not be as large as for generics3
• The European experience with biosimilars has shown that cost savings can
be expected between the 10-30% range4
© 2015 Amgen Inc. All rights reserved.
Patient safety/patient choice
© 2015 Amgen Inc. All rights reserved.
A person prescribed a biosimilar may have a different response than if they had been
prescribed the originator biologic - and vice versa - because the two are not identical
Switching back and forth between drugs is thought to potentially
increase the risk of an immune response against the drug itself.
Physicians should be well-informed on each product’s benefit/risk
profile and how it evolves over time.
Physicians, in consultation with their patients, should retain the
decision-making role in the choice of which drug is most appropriate
for their patient and the condition being treated.
Biosimilars
Amgen’s position on biosimilars
• Amgen believes that biosimilars have a role to play in the health care system
• Biosimilars -- unlike generic drugs -- are not identical to the originator
products they attempt to copy
• Amgen’s guiding principles:
© 2015 Amgen Inc. All rights reserved.
Ensuring quality
manufacturing
Ensuring patient safety Following sound science
In summary…
• Manufacturing processes of biologics are complex, distinct and unique to
each manufacturer
• Biosimilars, by definition, are ‘similar’ but not identical to the originator
drug
• Approval does not mean that a biosimilar is interchangeable with the
originator drug
 All biologic medicines should have distinguishable names
• Biosimilars have a role to play in healthcare
• Access and cost are important, as are patient safety, high quality and
reliable supply
• Physician/patient choice is critical in the decision-making process of which
medicine a patient should receive
© 2015 Amgen Inc. All rights reserved.
Discussion
Please visit Amgen’s biosimilars website
http://www.amgen.ca/english/science/biosimilars.html
© 2015 Amgen Inc. All rights reserved.
Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Web site www.survivornet.ca
Blog: http://jackiemanthornescancerblog.blogspot.com/
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/

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What is a biosimilar? All you need to know about the current biologics and biosimilars landscape in Canada

  • 1. What is a biosimilar? The current biologics and biosimilars landscape in Canada November 12, 2015 Karen A. Burke, Ph.D. Director, Regulatory Affairs, Amgen Canada Inc. © 2015 Amgen Inc. All rights reserved.
  • 2. Safe Harbor Statement This presentation contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements about estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of October 22, 2013 and expressly disclaims any duty to update information contained in this presentation. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company’s results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign) and difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.
  • 3. What we’re going to cover today… • Biologics: a quick overview • Biosimilars / Subsequent Entry Biologics (SEBs) – Growing interest in biosimilars – What we can learn from Europe – Health Canada perspective – What’s in a name? – Considerations on pricing – Patient safety/patient choice • Discussion © 2015 Amgen Inc. All rights reserved.
  • 4. Biologics are… used to treat serious diseases, including cancer, blood conditions, auto-immune disorders and neurological disorders Biologics are… typically made in living organisms, mainly by genetically engineering DNA Biologics are… far more complex than traditional chemical medicines (“small molecules”) Biologics are… large molecules The basics of biologics And… manufacturing matters © 2015 Amgen Inc. All rights reserved.
  • 5. © 2015 Amgen Inc. All rights reserved.
  • 6. Why does manufacturing matter? • Biologic medicines are typically made in living organisms mainly by genetically engineering DNA • The DNA is introduced into cells, and a particular cell line is selected for expansion • The cell line is expanded in bioreactors • The biologic drug is then isolated and purified using highly sophisticated and controlled technology © 2015 Amgen Inc. All rights reserved.
  • 7. Original Biologic Biosimilars What are biosimilars? © 2015 Amgen Inc. All rights reserved. Biosimilars are approved based, in part, on the studies done with the reference product Biosimilars are similar to the reference product, but they are virtually never the same Biosimilars are copies of biologic drugs developed after the patent has expired on an originator drug (the ‘reference product’)
  • 8. Seemingly minor differences can lead to products with different characteristics Burgundy France Santa Ynez California “Burgundian” Earthy “Californian” Fruity Temperate climate Frequent rainfall Intermittent sunshine Hot Rare rainfall Constant sunshine Pinot Noir SEBs are similar…But not identical… © 2015 Amgen Inc. All rights reserved. SEBs are similar…
  • 9. Why is there growing interest in biosimilars? © 2015 Amgen Inc. All rights reserved. Biologics represent approximately 1% of claims2 Biologic sales are growing at 14% per year vs. 4% for others 17% of drug spend is allocated to biologics It is estimated that by 2020, the US, EU, Japan and Canada will spend over $1 trillion on medicines1 Patent expiry could offer opportunities for drug spend savings
  • 10. Biosimilar landscape in Europe Biosimilar medicines have been available in the European Union (EU) for several years The necessary legal framework for biosimilar medicines was adopted in the EU in 20051 The first biosimilar medicines (human growth factor) were approved by the European Commission in April 20062 © 2015 Amgen Inc. All rights reserved.
  • 11. While not predictive of the future, the EU biosimilars experience is informative  Because biosimilars are not generics, the market has not reacted in a typical generic fashion  ESA biosimilars have captured about 17% of the total EU market by volume, and GCSF biosimilars about 35%  Originator products continue to be prescribed and utilized for years after biosimilars entry © 2015 Amgen Inc. All rights reserved. Legend: ESA (Nephrology) ESA (Oncology) ESA Average of Nephrology & Oncology GCSF ESA - Erythropoiesis-Stimulating Agent GCSF - Granulocyte Colony Stimulating Factor
  • 12. Canada’s biosimilar landscape In 2015, Health Canada approved a biosimilar insulin. More biosimilars are anticipated to become available in Canada over the next few years. In 2014, Health Canada approved Celltrion’s Remsima™ and Inflectra™. Both are biosimilar versions of Remicade® and are both named infliximab. Health Canada’s guidance on biosimilars was issued in 2010 In 2009, Health Canada approved Sandoz’ file for for Omnitrope™ - a recombinant human growth hormone © 2015 Amgen Inc. All rights reserved.
  • 13. Health Canada’s position on SEBs © 2015 Amgen Inc. All rights reserved. Biosimilars are not ‘GENERIC’ BIOLOGICS
  • 14. Health Canada does not support automatic substitution © 2015 Amgen Inc. All rights reserved.
  • 15. Important: the approvals for the biosimilar(s)may not be identical to the originator • In approving Remsima®/Inflectra®, Health Canada did not grant all indications held by the originator Remicade® © 2015 Amgen Inc. All rights reserved. Remicade® Remsima® and Inflectra® Indications RA, JIA, AS, PsA, PsO, adult Crohn’s, pediatric Crohns, fistulising Crohn’s, adult ulcerative colitis, pediatric ulcerative colitis RA, PsA, AS, PsO
  • 16. What’s in a name? Crestor® (rosuvastatin) Remicade® (infliximab) • INNs are managed by The World Health Organization (WHO) • For small molecules, the same INN is given to both the original “brand” product and the generic versions, because the active ingredients are identical ). WHO © 2015 Amgen Inc. All rights reserved. BRAND NAME INTERNATIONAL NONPROPRIETARY NAME, INN As biosimilars are not identical to the originator, they should have distinguishable names (brand and INNs)
  • 17. WHO’s biological qualifier An INN proposal – The WHO’s draft proposal for naming was released in July 2014 – That biosimilars be named using the current INN system, adding a unique identification code (Biological Qualifier), which is to be a four- letter code at the end of the drug name in order to distinguish the biosimilar drug from the biologic – The four-letter code will be assigned at random – Final proposal pending © 2015 Amgen Inc. All rights reserved. WHO policy on biosimilar naming is not yet agreed, nor have Health Canada or FDA taken a firm decision
  • 18. Drug 1 Drug 2 Drug 3 Drug 4 and brand name Taking a closer look at why a distinguishable name is important If a prescription is written with INN Patient could receive Patient will receive Removing uncertainty © 2015 Amgen Inc. All rights reserved. In the absence of a distinguishable INN, biologics prescriptions should include both INN and brand name
  • 19. Reporting adverse events: the importance of traceability for patients and prescribers It is unclear which medicine should be linked to the adverse event Pharmacist dispenses an one of many biologics with same INN Physician prescribes by brand name and INN Pharmacist dispenses stated brand or contacts physician to agree change Patient may have received one biosimilar, followed by another on the next dispensing In the event of an AE, reporter knows exactly which brand the patient was dispensed Physicians know which drugs are linked to adverse events Physician prescribes by INN only If AE occurs If AE occurs INN only Brand and INN © 2015 Amgen Inc. All rights reserved. In the absence of unique identifiers for all biologics, prescribing by brand name and INN supports accurate dispensing and correct identification of the brand in case of adverse events
  • 20. Considerations on pricing • Unlike for generic small molecules, biosimilar manufacturers have to appropriately invest in clinical development, manufacturing and post- approval safety monitoring programs similar to that of innovators1,2 • Because of this development investment, cost savings achievable for biosimilars may not be as large as for generics3 • The European experience with biosimilars has shown that cost savings can be expected between the 10-30% range4 © 2015 Amgen Inc. All rights reserved.
  • 21. Patient safety/patient choice © 2015 Amgen Inc. All rights reserved. A person prescribed a biosimilar may have a different response than if they had been prescribed the originator biologic - and vice versa - because the two are not identical Switching back and forth between drugs is thought to potentially increase the risk of an immune response against the drug itself. Physicians should be well-informed on each product’s benefit/risk profile and how it evolves over time. Physicians, in consultation with their patients, should retain the decision-making role in the choice of which drug is most appropriate for their patient and the condition being treated.
  • 22. Biosimilars Amgen’s position on biosimilars • Amgen believes that biosimilars have a role to play in the health care system • Biosimilars -- unlike generic drugs -- are not identical to the originator products they attempt to copy • Amgen’s guiding principles: © 2015 Amgen Inc. All rights reserved. Ensuring quality manufacturing Ensuring patient safety Following sound science
  • 23. In summary… • Manufacturing processes of biologics are complex, distinct and unique to each manufacturer • Biosimilars, by definition, are ‘similar’ but not identical to the originator drug • Approval does not mean that a biosimilar is interchangeable with the originator drug  All biologic medicines should have distinguishable names • Biosimilars have a role to play in healthcare • Access and cost are important, as are patient safety, high quality and reliable supply • Physician/patient choice is critical in the decision-making process of which medicine a patient should receive © 2015 Amgen Inc. All rights reserved.
  • 24. Discussion Please visit Amgen’s biosimilars website http://www.amgen.ca/english/science/biosimilars.html © 2015 Amgen Inc. All rights reserved.
  • 25. Canadian Cancer Survivor Network Contact Info Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca Web site www.survivornet.ca Blog: http://jackiemanthornescancerblog.blogspot.com/ Twitter: @survivornetca Facebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/