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The Biosimilar Age: Adoption, Perceptions and Implications for Marketing

Steve Gullans and Gregory Gallo

© 2013 Activate Networks 2

What does that mean?

Not a Brand….

Not a Generic..

It’s a Biosimilar!

© 2013 Activate Networks 3

Transition from Biologics to Biosimilars

Proprietary

Biologic

No

Alternative

Rituxan

Today in U.S.

© 2013 Activate Networks 4

In the Bulls Eye

© 2013 Activate Networks 5

Biologics Patent Cliff

http://www.mdpi.com/1424-8247/5/12/1393

© 2013 Activate Networks 6http://www.firstwordpharma.com/node/1118043#axzz2fSPfYLQL

Major Biosimilars in Development

Reference Product

2012 Sales $Billions

Total in Development

Rituxan/Mabthera $ 6.45 22

Enbrel $ 7.97 17

Neuogen $ 1.26 14

Neulasta $ 4.09 12

Epogen $ 3.40 10

Herceptin $ 6.15 9

Avastin $ 5.54 8

Aranesp $ 2.70 7

Humira $ 9.26 7

NovoSeven $ 1.54 5

© 2013 Activate Networks 7

Transition from Biologics to Biosimilars

Proprietary Biologic

ManyBiosimilars

Rituxan

22 “Bio-Rituxans”

Future

© 2013 Activate Networks 8

Slow Start with Great Potential

2010 sales:$250

million

2017 sales: Estimated $3.9 billion

© 2013 Activate Networks 9

Brand Drug Generic Biologic Biosimilar0

25

50

75

100

Rela

tive P

rice (

%)

Low Price Is the Driver

-50-80%

-20-30%

© 2013 Activate Networks 10

But….

Concerns and Issues:

• Efficacy and equivalence

• Safety

• Manufacturing

• Regulatory approval process in U.S.

• Adoption―Substitution ―Initiation―Interchangeability

© 2013 Activate Networks 11

EPO Brazil – Case Study of A Biosimilar• Analyzed 12 Biosimilar Epoetins from 5 manufacturers

• Potency varied 68% to 119% of label

• Isoform variations observed

• Bacterial endotoxins found in 3 products1

• Brazil Regulatory suspended import of 2 epoetins2,3

1Schmidt, CA et al. Arq Bras Endocrinol Metabol, 2003: 47, 183. 2 http://e-legis.bvs.br/leisref/public/showAct.php?id=92103 http://e-legis.bvs.br/leisref/public/showAct.php?id=8151

Product/Manufacturing Challenge

© 2013 Activate Networks 12

Price Matters…

Price Reductions Required to Mandate Biosimilar Use

New Patient

Existing Patient

• Price sensitivity is different for new vs. existing patients

© 2013 Activate Networks 13http://www.sec.gov/Archives/edgar/data/310158/000095012311097292/y93336exv99w1.htm

EU Biosimilar Use Increasing - Adoption varies by Country

© 2013 Activate Networks 14

Will We Really Trust a Look Alike?

© 2013 Activate Networks 15

Auto Industry Analog

Brands Generics Biosimilars

© 2013 Activate Networks 16

?

?

Evolution in the Pharmaceutical Industry

Brands Generics Biosimilars

© 2013 Activate Networks 17

Back to Where We Started…

• Is it a generic?

• Is it a brand?

• Or somewhere in between?

More important, how can you optimize resources to defend or if you’re launching a biosimilar, succeed?

© 2013 Activate Networks 18

Attaining Success in Biosimilars

• Which companies will successfully navigate:―Manufacturing costs higher than generics―Price competitiveness with brands will not be as big an

advantage―Promotion & Education

• HCP’s and Patients– Physician access– Multi channel resources but limitations

• Developing a “brand” identity• Payer relations

© 2013 Activate Networks 19

Maximizing Investments and Available Resources

• Identify physicians with central role in network and their connections

• Target more efficiently

• Accelerate knowledge flows

• Drive behavior faster and more efficiently

Identify essential HCP’s with outsized influence

© 2013 Activate Networks 20

Prescribers of Statins, 2009

Adopting Crestor + Generics

© 2013 Activate Networks 21

Prescribers of Statins, 2012

Adopting Crestor + Generics

© 2013 Activate Networks 22

Change in Market Share - Following Introduction of Alternatives

Lipitor

Crestor

Generics

© 2013 Activate Networks 23

Market Performance Varies by Community of Practice

Trend Lines~ Blue- Lipitor~ Yellow- Crestor~ Green- Generic

© 2013 Activate Networks 24

Influencers Make the Difference - Loyalty to Lipitor

January 2009 January 2012

One central key influencer stays loyal to Lipitor

Community remains loyal

More market share retained by Lipitormonths

© 2013 Activate Networks 25

January 2009 January 2012

Key influencers are early adopters of Crestor or generics

Most of the community switches to Crestor or generics

Influencers Make the Difference - Rapid Adoption of Alternatives

months

© 2013 Activate Networks 26

Case Study: Early Adopters vs. Influencers

Months Since Launch

5 Early Adopter is not influential in cluster

Early Adopter is highly connected and is highly influential in cluster

24

Few adopters in this cluster due to a lack of influential early-adopters

Influential Early Adopters result in widespread adoption in this cluster

© 2013 Activate Networks 27

Factors Impacting Patient Access

• Approval path

• Patient’s ability to switch

Interchangeability

• Comfort with new patients

• Willingness to switch patients

Prescriber Confidence

• Expect small price difference in US like the EU

• Fewer payer mandates

Price Difference

• Reimbursement restrictions

• Coverage restrictions

• Patient co-pay

Payer Requirements

• Efficacy / safety

• Costs, QC

• Post-market surveillance

Product & Manufacturing

© 2013 Activate Networks 28

Patients Will Have Questions …

“Is this medicine really the same?”

“Are you sure the FDA approved this?”

“Bio-what?”

Gee, I’ve never heard of Ponzi Pharmaceuticals.”

© 2013 Activate Networks 29

Branding of Therapeutics

© 2013 Activate Networks 30

Social Networks for Branding

• Facebook, Twitter, etc.

© 2013 Activate Networks 31

Monitoring Brand Awareness

“Name Dropper” Game • Addictive• Word association• Prompt with relevant

and irrelevant words• Thousands of people• Known demographics

© 2013 Activate Networks 32

Nexium vs. Abilify - Awareness of Drug’s Purpose

Heartburn

Depression

© 2013 Activate Networks 33

Nexium vs. Abilify: - Brand Awareness

© 2013 Activate Networks 34

Nexium vs. Abilify - Attributes

EffectiveMiracle cure

EffectiveLife saver

NauseaAddictive

SleepAddictive

© 2013 Activate Networks 35

Takeaways

• Don’t be lulled by slow start in the US―Market potential is great

• Multiple barriers will raise the game for everyone

• Efficient resource utilization will be critical―Development & approval―Promotion and marketing

• Just like advances in the science of drug development, advances in optimizing promotion resources will need to deployed to achieve success