What are the key strategies to win in biosimilars market? What should be your plan for payers, physicians, and launch? What should be the focus for pharmaceutical / biosimilar companies? Key Takeaways - - There is a need for a holistic approach to succeed in this market environment - Many biologics are administered by physicians; therefore, more emphasis will have to be directed at the physicians than was the case with small-molecule generics - Carefully constructed incentive from public and private payers / PBMs could boost biosimilar utilization significantly - Companies need to instill confidence & awareness in patients just like they do with other stakeholders - Launch biosimilars in emerging markets before developed markets to develop strong post-marketing data - Manufacturing biosimilars requires scientific expertise and experience - Success Checklist

1. What strategies should be employed to win
in Biosimilars?
- Santhosh R

2. Currently ‘affordability’ and ‘market access’ define biosimilars
Situation Analysis
Unmet Needs
- Market access
- Low cost
- Familiar
- More data
- More experience
- Better managed care coverage
- Low cost
Points of
parity
White
space
Competitor
Strengths of
difference
Our
Strengths of
difference
- Unawareness
- Need for data
- Lack of pathways
- Price increase
- Specialty drugs
are expensive
Our
disequity
Common
disequity
Competitor
disequity

3. There is a need for a holistic approach to succeed in this
market environment
Current Area of Analysis Growth Question
Ability to provide price discounts
How do we identify, build, and defend differentiation that is meaningful to
stakeholders?
Efficacy, safety data How do we develop points of parity to remain “at parity”?
Competitors familiarity
Should we neutralize competitors differentiation? If so, how? Or should we live
and let live
Biosimilars Unawareness
Lack of data
How do we improve reduce, eliminate disequities? Or can we reveal equities
that stakeholders are unware of?
Dosage / ease of admin. How can we identify new growth ideas around patients unmet needs?
Payer Physicians Patients
Need for a Holistic Approach to Win in Biosimilars Market
Regulatory Authorities
 FDA is cautious
 Safety to be top priority for FDA Consideration of Biosimilars.
 Requires switching studies for interchangeability
 Only 4 products in the market
 Working closely with Alliance for Patient Access and patient
advocacy groups to urge positive FDA policies

4. Many biologics are administered by physicians; therefore, more emphasis will
have to be directed at the physicians than was the case with small-molecule
generics
PrescribingMotivation
HighLow
High
Low
Awareness
 $$$ High Spending
 Early adopters
 Influenzers
Strong EmbracersIn Denial
Uninformed Patient-Centric
 $$$ High Spending
 Use digital strategies
 Education campaigns
 Develop and deliver content backed
by sources these physicians trust—
such as specialty societies and KOLs
 $ Low Spending
 Future adaptors
 Use digital strategies
 Education campaigns
 Develop and deliver content backed
by sources these physicians trust—
such as specialty societies and KOLs
 $$ Moderate Spending (short-term)
 Focus on the topics most likely to
inspire behavior change, such as
safety/efficacy information and
regulatory guidelines /best practices
 Develop and deliver content backed
by sources these physicians trust—
such as specialty societies and KOLs
 Create a road map for leveraging brand opportunities

5. Carefully constructed incentive from public and private payers
/ PBMs could boost biosimilar utilization significantly
Long-termTraditional
Economic Focus
Clinical/Health Focus
Launching a
product at a
lower price
Health
outcomes
story
Value story
and
supporting
evidence
Low cost-
sharing tiers
in formulary
Providing
Annuity
benefits
Improved
quality of
healthcare
services
Rebates,
Refunds,
Discounts
Clinical
positioning
Risk sharing
(Outcome-
based)
Healthcare
rationalization
Treatment
pathway
analytics
Head-on
trial data
Reduce Co-
pay or
eliminate

6. Companies need to instill confidence & awareness in patients
just like they do with other stakeholders
Presentation /
Diagnosis
Referrals
Treatment
Choice
Access
Maintenance /
Switch
DTC campaigns to educate patients about your biosimilar
 Website (e.g. https://www.merckclarifiesbiosimilars.com/)
 Workshops
 Newspaper, Magazine, TV, Radio
Develop and make available to all patients accurate, balanced,
and evidence-based information about your product Continuity of
support services:
Phone hotlines,
access to nurses,
online information,
co-pay cards and
other services
typically offered by
innovators.
Demonstrate
patient outcomes
and reinforce value
proposition.
Work alongside advocacy groups to develop patient education
programs that provide information necessary to patients to make
informed decisions.
 Risk-benefit
 Cost-savings
 Manufacturing quality, consistency
 Pharmacovigilance reports
Potential Benefit to Optimal Care
Low High

7. Launch biosimilars in emerging markets before developed
markets to develop strong post-marketing data
Market Attractiveness
EaseofDoingBusiness/SupportingRegulatory
Low High
High
Potential Quick Wins Target Short-term
Long-term PotentialLow Priority
US
India
China
Brazil
Mexico
South Korea
Turkey
South Africa
EU5 CountriesLocal
Partnerships
/ Tender
driven
Southeast Asia
Africa
Latin America
Hungary
Greece
Poland
Sweden
Norway
Japan
Reg. policies
in
development
Established

8. Manufacturing biosimilars requires scientific expertise and
experience
Scale up Acquisition Collaboration
 Scale up your R&D
manufacturing
capabilities
 Logical extension to
your existing business
 Build deep knowledge
base
 Acquire companies
with large-scale
production facilities like
the CMOs
 Acquire
biopharmaceutical
companies
 Access to production
technologies
 Access to
manufacturing
capabilities
 Local market access
 Full drug development capabilities & infrastructure required – process development &
biosimilars manufacturing
 High barriers to entry with $50mn - $500mn long term investments
 Need to adequately produce and supply consistent batches
 Design and characterize product early and strategically
 Improving easy of administration / dosing
Large companies have significant experience and have considerable advantage of new companies.
 Integrate in-country teams
 Fill gaps in various support areas by appropriate consultants
 Form oversight committee to support project team

9. Success Checklist
 Patient Awareness
 Are patients aware of
 biosimilars?
 your product?
 your product differentiations? Cost vs. quality?
 Physician Perception / Awareness
 How likely are physicians to prescribe your product?
 Are they aware of your product?
 Risk-benefit
 Ease of administration / dosing convenience, others
 Payer / PBM
 How likely are payers
 to add your product in lower-tier in formularies?
 promote your product?
 Global Strategy
 How many countries have you planned to launch the product?
 Local partnerships?
 Market Adoption
 What is the market uptake?

10. Thank you.
Connect santhu.hi@gmail.com