Marketing Plan B6 Biocon
Marketing Plan B6 Biocon
Marketing Plan B6 Biocon
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 No direct substitutes in this segment of Cancer
treatment
Other therapy including radio and chemo used
in 84% cases, Five year survival rate at 75% Other possible alternatives: Lapatinib,
Pertuzumab, ado-tratuzumab
Primary use of TZ at this phase, rarely its used in Stage II and Stage III
Oncology Value Chain on Supply side
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
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
Challenges in
Biosimilar
market