.

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: drmalhotrahemant@gmail.com

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