The generics industry is under constant pressure to introduce new products into the marketplace quickly while keeping costs down and quality high. Best Practices ®, LLC developed this study to identify effective strategies and processes for managing the critical bioequivalence studies central to generics development, while effectively managing quality, speed and cost. In addition, the study also looks at recent trends in outsourcing and geographical locations for BE studies. Further, the study provides metrics, executive insights, lessons learned and best practices.

1. Pharma Bioequivalence Strategies:
Performance Metrics, Processes & Trends
Best Practices, LLC
Strategic Benchmarking Research
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2. Contents
I. Executive Summary
Research Overview
Benchmark Participants
Key Findings & Observations
II. Outsourcing & Geographic Trends
III. Volume & Cost Metrics
IV. Bioequivalence Practices & Processes
V. Clinical Quality Assurance Strategy,
Structure & Performance
VI. Best Practices & Lessons Learned
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3. Generic Bioequivalence Benchmarking: Project Overview
Best Practices, LLC conducted this benchmarking research to provide comparative
cost, quality and productivity metrics and best practices that Generics manufacturers
can use in evaluating the performance of their bioequivalence testing programs.
Study Objective & Methodology Key Study Topics
This benchmarking study aims to identify Outsourcing Activities & Trends
key cost, quality and productivity metrics for Use of CROs in Less-Regulated
Regions
the process of conducting bioequivalence
studies required to bring a new generic drug Bioequivalence Volume & Cost Metrics
to market. Bioequivalence Practices & Processes
In addition to metrics, the study includes Use of Pilot Studies, Power
& E-Submission
executive insights, lessons learned and
best practices for productivity in the Clinical Quality Assurance Function
Dedicated CQA Prevalence
bioequivalence study process. & Structure
Qualitative and quantitative data for this Best Practices
study were collected through an online
Pitfalls & Lessons Learned
survey instrument.
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4. Benchmark Class: Companies Participating in Study
Twenty executives at 18 leading generic pharmaceutical manufacturing companies
participated in this benchmarking study.
Apotex, Clinigene, Dr. Reddy’s, GeneraMedix, Lupin, Merck, Naari, Perrigo, Ranbaxy, ratiopharm,
Roxane, sanofi-aventis, Sun Pharmaceutical, Teva, Wockhardt, Zars, Zentiva, Zydus Cadila.
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5. For Majority, < 1/4 of BE Studies Go to Less-Regulated Markets
A majority of the Generic companies in the study currently outsource fewer than
one-quarter of their bioequivalence studies to CROs in less-regulated markets (such
as India), while one-third outsource most studies to those regions.
Q. Approximately what percentage of your company's BE studies are outsourced to CROs in
less-regulated markets (such as India or Eastern Europe)?
% BE Studies Outsourced to CROs in Less-Regulated Markets
76-100% of studies 22%
1-25% of studies
51-75% of studies 11% 56%
11%
26-50% of studies
(n=18) % Respondents
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6. Increased Use Expected of CROs in Less-Regulated Regions
A majority of participants expect to increase their use of CROs in less-regulated regions
during the next two years. 65% expect to move more BE studies to India. Although 50%
plan more activity in Eastern Europe, it is the only benchmarked region where some
companies expect to decrease BE outsourcing.
Q. Please indicate whether you expect your company to change its level of use of CROs in less-
regulated regions within the next 24 months. (Indicate direction of expected change.)
Future CRO Use in Selected Locations
Level of Use Will Increase No Change Expected Level of Use Will Decrease
67% 65%
% of Respondents
50% 50% 50% Other Areas for Increased
Volume of BE Studies
38%
33% 35% • US (3)
• Canada
• Mexico
13% • Romania
• South Africa
Russia China Eastern Europe India
(n = 17 8 6 6)
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7. Generic Companies Average 3.27 BE Studies per Application
On average, participating Generic companies conduct 3.27 bioequivalence studies
(including both pilot and pivotal work) for each submitted ANDA. The median number
of studies is three.
Q. Please estimate the average number of bioequivalence studies (including pilot and pivotal)
that your company conducts for each generic drug application (ANDA) it submits to the FDA.
Number of Studies per Application
7
# of Studies
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3.27
3
2 2
Mean Max 75th Median 25th Min
Percentile Percentile
(n=18)
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8. Generics’ Cost per Volunteer per Period Averages $1,110
The estimated current cost of a clinical stay ranges from $110 to $3,200 across the benchmark class.
Although the two lowest responses came from Generic companies in India and the highest few from North
American companies, some Indian companies have higher costs than some North American companies.
Q. Please estimate your current average cost per volunteer per period (cost of clinical stay).
(Include meals, lodging, stipend, travel and other individual volunteer costs.)
Cost per Volunteer per Period
$3,200
$1,750
USD ($)
$1,110
$500 $400
$110
Mean Max 75th Median 25th Min
Percentile Percentile
(n=15)
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9. Pilot Study Results Often Yield Design, Speed & Cost Savings
For most companies, key benefits of using pilot studies in bioequivalence testing are
improved design of pivotal studies and faster screening of experimental formulations.
Saving time and/or money are additional benefits of using pilots.
Q. If you use pilot studies in the bioequivalence process, what benefits have you realized
as a result?
Pilot Study Benefits
Better design for pivotal studies 95%
Faster screening of experimental
79%
formulation
Saved money 47%
Saved time 37%
(n=19) % of Respondents
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10. More than Two-Thirds Have Dedicated CQA Groups
Sixty-eight percent of the participating companies have dedicated Clinical Quality
Assurance groups.
Q. Do you have a group dedicated to clinical quality assurance (CQA) within your company?
Generic Companies with Dedicated CQA Groups
No, 32%
Yes, 68%
(n=19) % of Respondents
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11. About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts work based on the
simple, yet profound principle that organizations can chart a course to superior
economic performance by studying the best business practices, operating tactics and
winning strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200,
Chapel Hill, NC 27517
919-403-0251
best@best-in-class.com
www3.best-in-class.com
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