1. Innovations in development for the biosimilar industry
www.healthnetworkcommunications.com/biosimilar
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2. Contents
Carsten Brockmeyer, Owner and Managing Director, Brockmeyer Biopharma GmbH
Rajiv Dua, Analytical & Stability Coordinator, Lupin Biotech
Prof Heinz Haenel, Diabetes Division R+D Projects, Sanofi Aventis
Dr Rustom Mody, Biosimilar Development Lead, Intas Biopharmaceuticals
Anita O’Connor, Consultant, Anita O’Connor Consulting
Dr Deven Parmar MD, Vice President - Global Clinical Research, Wockhardt
Joe Zhou, CEO, Wison/Genor Pharma
About Biosimilar Drug Development World Europe 2012
All the respondents to our e-book are speaking at Biosimilar Drug Development World Europe 2012.
This conference boasts a whole host of industry speakers. In addition to the above speakers further
speakers include:
Joerg Windisch, Global Head, Technical Development, Sandoz International GmbH
Cyrus Karkaria, President, Biotech Division, Lupin Ltd
Brian Hosung Min, Vice President, Strategic Business Development, Samsung
The Honorable Henry A. Waxman, Member of Congress, USA
Alexandre Moreau, Clinical Assessor in Oncology, Afssaps
Dr Marie-Christine Bielsky, Senior Medical Assessor, Biologicals and Biotechnology Unit, Licensing
Division, MHRA
Dr Phul Parvinder, Pre-clinical Assessor, MHRA
This conference will ensure your biosimilar strategy is effective and commercially sound. For full
details visit www.healthnetworkcommunications.com/biosimilar

3. What do you think is the number one hurdle for
Carsten
biosimilar development today?
Brockmeyer
The development of a biosimilar requires a target directed approach
Owner and Managing to achieve a molecule that is similar to an existing biological medicine.
Director However, since we are dealing with living cells to produce these
biologics, and since we have this batch-to-batch variability, it is not
Brockmeyer Biopharma expected that the two molecules are identical, minor differences are
GmbH acceptable - if they are sufficiently justified. If similarity has been
demonstrated on a physico-chemical, bio-physical and biological level,
Presentation: Workshop
then the number of scientific and operational issues in clinical
leader- Successful
development, registration and commercialization can be overcome.
registration of biosimilars
and biobetters in the EU
What skill set does the industry need to use for the
safe and quality development of biosimilars?
Excellence in analytics, target directed approaches in product development, out-of-the box thinking
in clinical development and registration, state-of-the-art quality systems and standards in
development and manufacturing, scale-up and commercialization expertise, and last but not least
good project management skills.
What challenges are unique to clinical trials for biosimilars and how can we
overcome these?
Clinical development of a biosimilar is a confirmation of a target directed CMC development and
requires a lot out-of-the box thinking. Bioequivalence to the reference product has to be shown first,
followed by demonstration of similar efficacy and safety in a sensitive indication, which is again done
in a direct comparison with the reference product. In many cases it will need an equivalence study
design. Dose finding studies are not necessary and extrapolation to other indications, which are
approved for the reference product, should be possible based on the same mechanism-of-action.
Immunogenicity is an important aspect and needs specific observation. On the operational side most
of these studies will be multinational studies including a larger number of developed countries and
less developed countries. There are logistic challenges with supply, cool chain, site and patient
recruitment, GCP, etc. How to overcome these challenges? Build the right talent in-house and
choose the best organization to work with.

4. Rajiv Dua What do you think is the number one hurdle for
Analytical & Stability
biosimilar development today?
I think for Biosimilar development today, the major hurdle is less
Coordinator clarity and complexity in terms of intellectual property and lack of
marketing strategies besides huge cost involved in complicated
Lupin Biotech manufacturing, establishing physicochemical and Clinical
comparability to get the biosimilar products comparable to
Presentation: Cold chain Reference Medicinal Product (RMP) in terms of quality, Safety and
Efficacy.
management for
biosimilars
What skill set does the industry need to use for the
safe and quality development of biosimilars?
• Most important is technically and scientifically sound team.
• Quality by Design Technology (QbD), Process Analytical Technology (PAT), Design of
Experiments (DOE), Regulatory Strategic roadmap, appropriate clinical strategy and trial
design are the foremost skill set required for the safe and quality development of
Biosimilars.
• The implementation of these technologies will contribute towards defining Critical Quality
Attributes (CQAs), Critical Process Parameters (CPPs) and Operating Range (OR) for the
products, which will further help us to understand process, product, less development costs
and to avoid post approval changes.
What challenges are unique to clinical trials for biosimilars and how can we
overcome these?
• Unavailability of innovator Clinical data is the main hurdle for biosimilars clinical
development. If it is available biosimilar CT protocol can be designed that reduce CT cost &
will generate effective clinical data. This can be overcome with the help of regulatory
agencies (FDA, EMEA), who can provide access to the innovator clinical data.
• The unique challenges for Biosimilars clinical trials include:
Immunogenicity concerns.
Extent of characterization of the mechanism of action and targets of the innovator
compound.
Indication and patient population.
The complexity of clinical endpoints that may be acceptable to regulatory authorities
globally.
• To overcome these challenges, few strategies shall be applied:
Extensive characterization of Reference Medicinal Product (RMP) and Biosimilar.
Extensive evidence of analytical comparability and non-clinical similarity to RMP
must be established in a stepwise process during development.
Choosing the countries / Markets where these are an immense need for biosimilar
and where regulatory agencies are willing to work collaboratively with biosimilar
companies.
Selecting an appropriate population and sample size.
Incorporating the right clinical endpoints.

5. What do you think is the number one hurdle for
Prof Heinz Haenel biosimilar development today?
Diabetes Division R+D To satisfy the regulatory bodies in their concern of increased
Projects immunogenicity and the lack of methodological expertise of the
companies to fully characterise the tertiary structure of the
Sanofi Aventis peptides besides the other properties
Presentation: Biosimilars
– the devil is in the detail What skill set does the industry need to use for the safe
and quality development of biosimilars?
Expertise in Phase III immunological trials, analytical expertise to
differentiate insulin analogues from regular insulin, ability to check the full by-product
spectrum plus possibly the tertiary structure
What challenges are unique to clinical trials for biosimilars and how
can we overcome these?
The identification of immunogenicity is dependent on various factors which are not fully
understood. The necessary patient number and exposure time is under debate, depending
on the statistical plan and method. On the other hand it is not undisputed in clinical science
what impact a modified immunological profile has on the clinical outcome. Example:
neutralizing antibodies versus non-neutralizing antibodies.

6. What do you think is the number one hurdle for
Dr Rustom Mody
biosimilar development today?
Biosimilar Development
Interchange ability not allowed for biosimilars.
Lead
Intas Biopharmaceuticals
What skill set does the industry need to use for the safe and
Presentation: Biobetters quality development of biosimilars?
Risk-based approach based on analysis of many lots of Reference
Medicinal Product to determine limits of Critical Quality Attributes.
What challenges are unique to clinical trials for biosimilars and how
can we overcome these?
Acceptance of Innovator’s product (from Europe) for submission in US and vice-versa.

7. What do you think is the number one hurdle for
Anita O’Connor, biosimilar development today?
Consultant Money: The costs involved in developing biosimilars for worldwide
markets is the number one hurdle in my view. It is extremely
Anita OConnor expensive to manufacture the biosimilar, characterize it alongside
Consulting the innovator molecule, do the required preclinical pharmacology
and toxicology studies, and design and execute at least 1-2 clinical
Presentation: Workshop trials.
leader- The evolving
quality (chemistry and
manufacturing) paradigm
for biosimilars
What skill set does the industry need to use for the
safe and quality development of biosimilars?
Manufacturing: the success of a biosimilar molecule depends heavily on the manufacturing skills of
the developer. The manufacturing (quality) of the biosimilar requires state of the art CMC
capabilities and bioanalytical characterization studies as development progresses. If the developer is
not experienced in the production of drugs produced by biotechnology from the pilot to the
commercialization stage, I think they are at a disadvantage compared to the many CMC plants
making these drugs around the world. I see CMC as the foundation of the biosimilar development
program because if the molecule is not 'similar' enough to suit the regulatory authorities, it cannot
proceed into preclinical or clinical testing.
What challenges are unique to clinical trials for biosimilars and how can we
overcome these?
Clinical trials: right now the designing and executing 1 or 2 clinical trials that meet the approval of
multiple regulatory agencies around the world is a bit daunting. The regulatory requirements for
biosimilars are far from being 'similar' in the EU, the US and Japan. The challenge is that these
regulatory requirements are rapidly evolving; the regulators are in a learning mode because this is
truly a nascent area for drugs produced by biotechnology.

8. What do you think is the number one hurdle for
Dr Deven Parmar biosimilar development today?
MD Guidelines in US
Vice President - Global What skill set does the industry need to use for the
Clinical Research, safe and quality development of biosimilars?
Wockhardt Trained Manpower, scientific Advise
Presentation: Clinical trial
requirements – is the
What challenges are unique to clinical trials for
extent and depth of trial biosimilars and how can we overcome these?
requirements necessary?
Assay Development, Protocol Endpoints
What do you think is the number one hurdle for
Joe Zhou biosimilar development today?
CEO Interchange-ability
Wison/Genor Pharma What skill set does the industry need to use for the
safe and quality development of biosimilars?
Presentation: Reference Similarity determination
product selection and cell
line development What challenges are unique to clinical trials for
biosimilars and how can we overcome these?
Efficient clinical design with minimal usage of innovative biologic
drug(s)

9. Thank you for downloading Health Network Communication’s Biosimilar Drug Development World Europe
e-book. All views and opinions expressed in this document belong to the named speaker. For more
information please visit www.healthnetworkcommunications.com/biosimilar