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

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 StatementThis 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


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


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


Original Biologic Biosimilars

What are biosimilars?


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

BurgundyFrance

Santa YnezCalifornia

“Burgundian”Earthy

“Californian”Fruity

Temperate climateFrequent rainfall

Intermittent sunshine

HotRare rainfall

Constant sunshine

Pinot Noir

SEBs are similar…But not identical…


SEBs are similar…

Why is there growing interest in biosimilars?


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


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


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


Health Canada’s position on SEBs


Biosimilars are not ‘GENERIC’ BIOLOGICS

Health Canada does not support automatic substitution


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®


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


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


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 4and

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


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

?


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


Patient safety/patient choice


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:


Ensuring quality manufacturingEnsuring 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


Discussion

Please visit Amgen’s biosimilars websitehttp://www.amgen.ca/english/science/biosimilars.html


http://www.amgen.ca/english/science/biosimilars.html

http://www.amgen.ca/english/science/biosimilars.html

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

Health & Medicine

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