Generics#ANDA#505(j)#product development#infringement

1. Generics – Lead the way head
Guru Balaji.S
Product development scientist

2. Focus
points
Global pharmaceutical market
Indianpharmaceuticalindustry
PharmaceuticalR&D in a nutshell
Introduction
QbD
Global Generic product development
Quality
TheCTD triangle, Regulatorydossier
Conclusions and implications

3. Introduction
Key global health care regulators has the common goals
of improving health outcomes, while controlling costs
and expanding access to more of their citizens
There is a rapid expansion of demand for medicines in
the world's fastest growing economies, fewer new
medicines reaching patients.
There is a rapid shifts in the mix of spending between
branded products and generics

4. Global
Pharmaceutical
Domestic market
(India)
Bulk drugs
(API,
intermediates)
Formulations
( Tablets, capsules,
etc)
International markets
(US, EU, Japan and etc.)
Generics
Patented
drugs
Non-
patented
drugs
NDDS NCE
Global pharmaceutical market
Mostly almost all NDDS,NCE formulation are patented

5. Global Generics market

6. Global Generics: Facts and figures
Global
Generics
The top 10 global generic
pharmaceutical companies
account for 47% market
share
The global generic
pharmaceutical market is
worth over $150 billion
and is growing at CAGR
(2013-2018)
of 8.4%
Blockbuster drugs has
losed patents between 2010
and 2017
Over the next 5 years,
emerging markets will
grow at 15-20% and
matured at 6-10%growth
The top 8 global markets
comprise 80% of the total
generic sales

7. Pharmaceutical R&D in a nutshell
Source: Frost and Sullivan
analysis

8. Pharmaceutical drug development process-”The
pipeline”

9. 200.2
380.6
2015 2016 2017 2018 2019 2020 2021
RevenueUSDBillion
Global Generic drug
market,2015-2021 (USD)
Million)
Revenue in
$ billion

10. Key drivers for the change
Overwhelmed health systems around the globe
to control general spending on health care.

11.  India’s pharmaceutical industry has filed the highest number of DMFS with
USFDA and by the end of year 2015, number of filings stands at 3820. India’s
ANDAS totalling 3470 by Feb 2016 covers all ATCs.
 Indian Pharmaceutical in 2015-16 – An overview
Global Pharma market size in the calendar year 2015 is estimated at $1060
billion as per IMS with a very marginal growth rate of 1-2%. India’s total exports
of Pharmaceuticals (APIs, Generics and Alternative system of medicine) during
2015-16 was $16.89 billion with a growth of 9.44%. India’s exports in INR terms
has recorded a growth of 17% and was valued at 110,522 crore during Fy-15.
 Global generic market is estimated to be of size $ 294 billion. The market grew
2015approximately by 4% as Per IMS (World renowned market audit agency)
data. India, a predominant player in Global Generic market has clocked $ 12.6
billion of Exports out of this $ 294 generic market with a growth of 12.8%
during the year2015-16.
Indian pharmaceutical industry

12. Future trends and directions
Source: Frost and Sullivan
analysis
Key Trends
Balance in terms of healthcare expenditure and sales revenue is likely to shift from developed m
emerging markets owing to immense market opportunities and untapped market potentials.
Partnerships, mergers, acquisitions and strategic alliances will help both branded and gen
expand their global footprint and gain market shares.
Large generic companies seek to establish their own R&D entity and hence are like
investments in R&D activities for long-term growth.
Generic manufacturers tend to increasingly focus on higher value biological therapies, biosimilar
controlled release products, sterile formulations and niche therapeutic segments, which are less
competitive yet commercially attractive.
Generic consumption is likely to be favoured in a big way by the government,
policy-makers and physicians owing to the huge cost-saving benefits to the patients
and healthcare expenditure.

13. Difference in the cost

14. New Drug & Generics

15. Global product development
flow chart

16. Aspects Traditional QbD
Pharmaceutical development Empirical Systematic : Multivariate experiments
Manufacturing process Fixed Adjustable with design space,
opportunities for innovation
Process control In process testing for go/on-go; offline
analysis wide or slow response
PAT utilized for feedback and feed
forward at real time
Product specification Primary means of quality control;
based on batch data
Part of the overall control strategy,
based on the desired product
performance
Control strategy Mainly by intermediate product and
end product testing
Risk based; controlled shifted up
stream, real time release
Lifecycle management Reactive time problem and OOS; Post
approval changes needed
Continual improvement enabled within
design space
Pharmaceutical aspects: Traditional versus QbD

17. Roadmap for QbD
Define Target product
profile Product quality
characteristics ensuring
safety and efficacy
Identification of critical
quality attributes
(CQA’s)
Risk Assessment
Material Attributes
CQA’s
Process
parameters
CQA’s
Design space
Control strategy
quality risk management
( Life cycle management continuous )

18. Quality = Quality of Personnel (Qualification, Training…)
+ Quality of Materials (Specifications, Approved Suppliers...)
+ Quality of Means (Qualified equipment's, maintenance…)
+ Quality of Media (GMP premises, Controlled environment…)
+ Quality of Methods (Calibration, Validation…)
QUALITY
Raw Materials
Personnel
Procedures
Validated processes
Equipment
Premises
Environment
Packing Materials
The composition of
quality

19. The CTD Triangle

20. Regulatory Dossier
Regulatory approach:
Parameters US Europe Other markets India
API
USP Ph.Eur. USP / Ph.Eur. IP
USDMF COS (CEP) / EDMF DMF requirement
depends on the target
market
Excipients USP Ph.Eur. USP / Ph.Eur. IP
Reference
product
US Europe Depends on the
target market
Indian (if not
available, then US
or Europe)
Packaging
materials
Complying to USP Ph.Eur. USP / Ph.Eur. IP
Finished product
USP As per Ph.Eur.
General requirement
USP / Ph.Eur. IP
Submission batch 1 2 2 or 3 -
Submission batch
size
100,000 units or 1/10th
of commercial batch
100,000 units or
1/10th of commercial
batch
Depends on the
target market
No such
requirement

21. Regulatory Dossier
Regulatory approach:
Parameters US Europe Other markets India
Stability data 1 batch 2 batches 2 or 3 batches 3 batches
Stability condition Zone I & II
condition
Zone I & II condition Depends on the target
market
Zone IV condition
Comparative
dissolution study
3 media 3 media Depends on the target
market
1 to 3 media
Input materials TSE/BSE, OVI
statements
TSE/BSE Depends on the target
market
No such
requirement
Packaging
materials
Food grade
certificate
Food grade certificate Depends on the target
market
No such
requirement
Method validation
data
As per ICH ICH ICH No such guideline
Process validation
data
Not required Not required Depends on the target
market
Not required for
submission
Bioequivalence
study
US reference
product under fast
and fed condition
European reference
product (generally
under fasting
condition)
Generally fasting bio study Fasting bio study
Bioequivalence
study
USFDA approved
CRO anywhere in
the world
MHRA/EU approved
CRO anywhere
Depends on the target
market
Indian study
required

22. Conclusions and implications
 Regulations favoring generics, wider health insurance coverage by
Government and private bodies, and better co-operation from physicians and
pharmacists are expected to boost generic consumption.
 The consolidation wave is likely to rise high in the global generic
pharmaceuticals market
 CNS and Cardiovascular are expected to be the therapeutic areas of
interest for generic drug manufacturers.
 However, market participants are likely to face challenges due to
increasing pricing pressure, price-cuts and regulatory barriers.
Source: Frost and Sullivan
analysis

23. Thanks
s.gurubalaji@gmail.com