MARKETING PLAN FOR

TRASTUZUMAB BIOSIMILAR

- Submitted by
Group B6
Biocon-Mylan alliance in Trastuzumab biosimilar
May, 2015
Biosimilars - Generic
Biocon completes clinical trials on TZB version of biologics
Nov., 2016
Biologics Drugs
Biocon-Mylan submits application for Trastuzumab biosimilar manufactured by micro-
organisms
July, 2017
FDA Food and Drug
FDA recommends approval of Trastuzumab biosimilar Administration, reviews
Target Date for Market Launch Early 2019 and approves drugs on
safety and efficacy for
Project Objective: Construct a Go-to-Market strategy with intent to marketing in US
differentiate Mylan-TZB in the market from Herceptin (Innovator for TZ)
Herceptin is the Brand
name of TZ
(Trastuzumab)
TZ: One of the top Cancer drugs with great
performance in HER2+ BC treatment
Product History:
Treatment Pathway for HER 2+ Breast Cancer
Herceptin Roches innovator product of
eBC Early Stage Cancer localized Undergo Trastuzumab
treatment with once cycle of therapy,
Five year Survival rates at 98% Sales (2015) $5.5 Billion
Provides 18% increase in survival chances

aBC Stage II Cancer localized but advanced
Other therapy including radio and chemo used
in 84% cases, Five year survival rate at 75%
No direct substitutes in this segment of Cancer
treatment
Other possible alternatives: Lapatinib,
Pertuzumab, ado-tratuzumab

aBC Stage III Cancer metastasized

Radiotherapy is the only treatment available,
Five years survival rate a 22%

Primary use of TZ at this phase, rarely its used in Stage II and Stage III
Oncology Value Chain on Supply side

General Regulations Drug Procurement Drug Prescription Drug Dispensation

Pricing and Market Rebate program: 100% Biosimilar Quota: Automatic substitution:
Access: Trastuzumab is reimbursement for Government hospital For TZB substitution is
unregulated trastuzumab in US can would include policy possible with Herceptin if
Biosimilar pricing: 30% encourage replacement based recommendation not available but its not
mark down to be Open-house contracts: to use biosimilars recommended on
competitive Hospital Organizations Prescribing budget: patients with history of
Originator pricing: May and Clinic groups may Clinics under insurers auto-immune disorders
mark down based on source through these influence have strict
market erosion contracts budget requirements
Channel: For TZ, the mail Tenders: Fixed pricing Treatment initiation and
and online order channel over a period for a set switching: Mylan-TZB
are blocked group obtained switchable
status
Market Potential for TZB
MARKET SIZE - HERCEPTIN MARKET PENETRATION - HERCEPTIN

US Population 320 million Total Sales in US (2015) - $5.5 billions

Percentage of Females 50.8% Market Size - $8.73 billion
Target Market 163 million Total Market Penetration 63%
Rate of Occurrence (Breast Cancer) 5000 per 1 million
Population affected with breast cancer 0.81 million ESTIMATED MARKET SIZE TZB
Population affected with HER2+ cancer 1,38,500 (17%)
Patients those can be treated through TZ 1,24,700 Extrapolated Data
(90%) Compounded Annual Growth Rate 8.4%
Yearly Cost of Drug - $70,000 Total Sales in US (2017) - $6.46 billion
Total Market Size - $8.73 billion Total Market Penetration 73%

Market Size
Market Available 27%
Market Available (0% competition from TZ) - $1.64
billion
Market Available (Competition from TZ) - $6.11 billion
Upcoming Competition
Herceptins Biosimilar already launched in markets of India (Canmab) and South Korea (Herzuma)
Herceptins patent expired in 2014 in Europe and will expire in 2019 in the USA
Looser regulatory pathways and clinical requirements coupled with higher acceptability in Pharmerging
markets gives local players a more level playing field
Biosimilars are riding on a proposition of being a cheaper alternative to Roches Herceptin
Competitive drugs
Advantage to Mylan/Biocon for their drug is ready with all FDA approvals and is ready to hit the market
Allergan Amgen Samsung Bioepis Oncobiologics
Stada/Gedeon BioXpress
ABP 980- filed BLA in SB3-filing accepted in EMA Viropo with
Richter Therapeutics
USA in July 17 in Oct 16 DM Bio

South Korea with plans to become a leading biosimilars player, is actively expanding its world-class clinical
trials and production infrastructure, cultivating bio-specialized manpower, reinforcing global export capability,
building R&D, legal and system support strategies.
Channel Segmentation
Major Segment :
Hospitals
Developed good
relationships with
Oncology departments of
Hospitals
High Marketing Spend
They also target Clinics
but the drug is transferred
via Hospitals
No direct communication
between Roche & Clinics
Direct Selling to Clinics Low Prescriber
No head on competition
with Roche
No direct Selling to
Hospitals in the first
phase
Leverage the Salesforce of
Biocon & Mylan
Different nature of
contracts with the clinics
Challenges in
Biosimilar
market
acceptance
Patients attitude towards
bio similar is not
great(Branded mentality)
Targeting individual
Clinics will lead to more
number of contracts
greater administrative
work for the salesforce
Clinics have their unique
way of treatments
Channel Targeting and Positioning

We use the clinics Core value proposition

channels to reach is that the side effects
This brings the
those 27% customers risk of neutropenia
effective cost of chemo
that are using chemo which is 75% with
to (20000+26000)
as replacement of chemo will reduce
which is $46000
herceptin due to its costs to customers by
cost $26350 (17x25%x6200)
THANK YOU