Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
.
BiosimilarsBiosimilars in Oncology:in Oncology:
Dr. Hemant Malhotra,Dr. Hemant Malhotra,MD, FRCP (London), FRCP (Edinburgh), FACP (USA), MNAMS, FUICC, FICP, FIMSA
Professor &Head, Dept. of Medical Oncology,
Sriram Cancer Center, MG Medical College & Hospital, Jaipur.
Email: [email protected]
BiosimilarsBiosimilars in Oncology:in Oncology:IntroductionIntroduction
Continuum of Small Molecule and Continuum of Small Molecule and Biologic Therapies in Size & ComplexityBiologic Therapies in Size & Complexity
1
Hard Facts: What We Cannot IgnoreHard Facts: What We Cannot Ignore
$GDP: 25,000+
Per Capita: ~37000
MabThera~30,000
RoWNHL
220,000220,000 Avg. Per CapitaCapita
500-3500
Avg.
2015
Sub-Saharan Africa
Latin America and Caribbean
Middle East and North Africa
Europe and Central Asia
East Asia and Pacific
South Asia
(Millions of poor people)
Avg. GDP
5-15,000
Half the world lives in this
circle
Affordability for Biologics worldwide is a huge problemAffordability for Biologics worldwide is a huge problem*International definition of poverty is <1.25$/day, OMR: October 2013
30 %
Economic spectrum in IndiaEconomic spectrum in India
5 %65 %
.
Barriers to access due to cost and availability-India
Conclusions: The overwhelming majority of patients eligible for HER2-targetedtherapy in our institution are unable to receive it because of financialconstraints and limited access to health insurance. There is a higher fraction ofpatients with the triple negative phenotype compared to the Western population.
As we have reported above an estimated 441 patients were eligible to receive HER2-targeted therapy in the year 2008 in our institution. However, only 8.61% of thesepatients were able to receive such treatment and nearly half (4.54%) of the HER2-targeted therapy was through patient participation in clinical trials. The low usage of ahighly effective treatment is ascribed to the financial constraints that arecommon in our patients and a healthcare delivery model wherein the majority ofpatients have no access to any form of health insurance.
Indian Journal of Cancer | October-December 2011 | Volume 48 | Issue 4
Figure 1. Escalating costs of insurance premiums and employee healthcare contributions compared with employee earnings and inflation, 1999 to 2010. Cornes P.3 With kind permission from Springer Science+Business Media: Targeted Oncology, The economi c pressures ...
David Henry, Carrie Taylor
Pharmacoeconomics of Cancer Therapies: Considerations With the Introduction of Biosimilars ☆ ☆☆
Seminars in Oncology, Volume 41, Supplement 3, 2014, S13 –S20
http://dx.doi.org/10.1053/j.seminoncol.2014.03.009
2
.
Both developed and emerging markets seek high-value, low cost alternatives to first-generation innovator biologics
Market size of biosimilars is estimated to be $20B by 2020 globally , growing at a CAGR of
Need for BiosimilarsNeed for Biosimilarsinnovator biologics
Blockbuster success of Biologics drugs and multiple biologics going off-patent in this decade creates a large market opportunity for biosimilars
Dev eloped markets face mounting and unsustainable healthcare costs
Dev eloped Markets Emerging Markets
$20B
$212B
2013 F2020
Forecast
BiologicsBiosimilars
$20B by 2020 globally , growing at a CAGR of >30% YOY…
$2.5B
$170B
… and about 50% of the biosimilar opportunity w ill be outside the developed markets**
13% 12% 5.20%
100%
0%25%50%75%
100%
India China Russia Europe
Trastuzumab penetration in emerging markets relative to Europe, 2011
Emerging markets lack access to biologics due to their unaffordable prices
1 Brazil, India, Russia, China
RoW
Japan
US
Europe
EM1
19%
32%
16%
29%
3%
Source: IMS Health, EvaluatePharma Internal Analysis; ** in terms of volumes
0
100000
200000
300000
400000
500000
2013 2015 2020Incidence Mortality
Estimates for Non-Hodgkin’s Lymphoma (World)
Projected Developed Market Spend on 11 Specific Biologics (in 000’s)
BiosimilarBiosimilar patents & Countries with patents & Countries with specific specific biosimilarsbiosimilars guidelinesguidelines
3
BiosimilarsBiosimilars across various across various countriescountries
Number of Number of biosimilarsbiosimilars clinical trials clinical trials started between 2007 and 2014started between 2007 and 2014
.
U.S. U.S. biosimilarsbiosimilars savings projected at savings projected at $250B in 10 years, thereby improving $250B in 10 years, thereby improving
biosimilarbiosimilar accessaccess
4
.
The Paradigm shift needed in The Paradigm shift needed in understanding Biosimilarsunderstanding Biosimilars
Clinical Trials
PK/PD
Pre clinical
Biological Char
PC
The world viewed by us physicians till today…
“It is all about clinical trials: PFS, ORR, OS, etc.”
CT
PK/PD
Pre clinical
Biological Characterization
Physicochemical Characterization
… the world we will need to understand today
“It is all about totality of evidence driven by basic science, supported by real world
data”
The Regulatory Balance!The Regulatory Balance!
Too stringent Regulatory Approval Criteria:•Late/no approvals•Expensive product•Out of reach of most patients
Too lenient Regulatory Approval Criteria:•Too many products•Sub-standard products•Questionable efficacy/safety
Summary & ConclusionsSummary & Conclusions
• Quality Biosimilars are a necessity not only in developing countries but also in developed countries
• No compromise on the efficacy and quality of the biosimilar
• Ways and means needed to ensure quality of the produce with accelerated & abbreviated approvals processes
• Biosimilars are there to stay
5
Primary Goal: Primary Goal: Patient benefit!!Patient benefit!!
THANK YOUTHANK YOUTHANK YOUTHANK YOU