Teva in BioSimilarS

Teva in BioSimilars
Improving access to treatments of serious diseases
improving
access
06What is a Biotech drug?
14What is a Biosimilar?
22Teva’s corporate Identity Card
07The picture of today’s
Biotech drug landscape
15How are they developed?
24Challenges & Critical success
11The future opportunity
16The Regulatory Environment
Factors
25Teva’s Commitment
28A Recipe for success
Biotech drugs
Biosimilars
BIOSIMILARS at teva
INTRODUCTION
TEVA Today
TEVA is ready to meet the biosimilar challenge
TEVA Pharmaceutical Industries Ltd., headquartered in
Israel, is a global pharmaceutical company specializing in
the development, production and marketing of generic and
proprietary branded pharmaceuticals and active pharmaceutical
ingredients. TEVA is leader in the generic pharmaceuticals,
and among the top 15 pharmaceutical companies in the world.
TEVA has made, and will continue to make, substantial
investments in the ability to develop and produce biotech
products. A generation of biotech drugs are reaching
the end of their patent lives, heralding the market entry
for biosimilars.
Worldwide, TEVA has over 40,000 employees and production
facilities in Israel, North America, Europe and Latin America
and reached $18.3 billion net sales in 2011.
TEVA focuses on products with meaningful differentiation
from existing products in terms of clinical attributes, expected
economics value and benefit to patients and health insurers.
The cost of these biosimilars are expected to be lower than
the originator biopharmaceuticals, making medications
accessible to patients who might otherwise not be able
to afford them.
Improving
access
Biotech drugs
Biotech drugs
are protein-based medicines
Insulin
Herceptin
Paracetamol
Large and complex molecules
Produced by biological systems rather than chemical synthesis
 “Biological medicinal products” (also referred to as biopharmaceuticals or biotech drugs) are medicinal products containing biotechnology-derived proteins as active
substances. Biotech drugs, introduced in the early 1980s, are more specific and therapeutic target-oriented than small molecules and often less toxic. Traditional
pharmaceutical drugs, such as paracetamol, are small, simple molecules, manufactured by chemistry and usually work through chemical reactions to achieve the
desired result. Biotech drugs, on the other hand, are made from biological material, like proteins and antibodies, produced by living systems and consist of very large,
complex ‘heterogeneous’ molecules that are often folded and twisted in such unique ways that are difficult to duplicate. Given the immunogenic potential of these proteinbased medicines, the human body’s immunological response must be tested rigorously and monitored to ensure that patients are receiving the desired benefits of the
product in a safe manner.
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Biotech drugs
treat serious diseases
The emergence of biotech drugs has
revolutionized the treatment landscape in
a number of therapeutic areas. By developing
products based on the human body’s own
endogenous biological processes, biotech
companies have been able to create
products with therapeutic potential previously
unattainable through treatment with
traditional drugs.
Worldwide, the lives of over 300 million
people have been changed markedly by
the availability of a growing number of
biotech drugs.
Biotech drugs are used to treat a wide range
of serious and rare diseases, such as cancer,
autoimmune diseases and anemia.
For example, the biotech drug Herceptin
(trastuzumab, a monoclonal antibody),
initially approved in 1998, has earned
Dr. Dennis Slamon a number of research
awards for a therapy that was the first to
target a specific type of breast cancer.*
®
*Source : Herceptin-Dr. Slamon
UCLA Jonsson Comprehensive Cancer Center, Triumph issue fall-winter 2007,
available at: www.cancer.ucla.edu/pdf/Triumph_Slamon.pdf (accessed 5 July 2011)
**Source : IMS padds 2011
The top 10 biotech drugs today**
Indication
Molecule type
$bn Sales (2011)
Humira
Autoimmune
MAb (anti-TNF)
7,3
Enbrel
Autoimmune (RA, Psoriasis, Crohn’s)
Fusion-protein (anti-TNF)
6,9
Remicade
Autoimmune
MAb (anti-TNF)
6,9
Rituxan
Cancer (hematological)
MAb (anti-CD-20)
5,8
Avastin
Cancer (solid tumors)
MAb (anti-VEGF)
5,3
Lantus
Diabetes
Long-acting insulin
5,3
Herceptin
Cancer (solid tumors)
MAb (anti-HER2)
4,7
Novorapid/Novomix
Diabetes
Short Acting Insulin
4,4
Neulasta
Cancer (supportive)
Long-acting GCSF
4,3
Lucentis
Wet Age Related Macular Degeneration
MAb (VEGF-A inhibitor)
3,9
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sales increased 5 fold in the last decade,
reaching $155B in 2011*
Biotech drugs 155
138
127
119
107
92
79
67
57
46
39
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
Global biotech drug sales, $ bn
 Biotech drugs make up one of the fastest growing segments of the global pharmaceutical market. According to IMS Health, the biopharmaceutical market reached
global sales of over $100 billion in 2010. Bharat Book Bureau notes that “The growing interest in biotechnology development has transitioned the pharmaceutical
industry to biopharmaceuticals in less than a decade”.
*Source : IMS padds 2011
08
Today, the average cost of treatment is high*
Schizophrenia
Zyprexa
3,200
6,500
Anemia
Epo
8,500
7,500
Anemia
Aranesp
6,500
7,600
RA
Remicade
18,400
13,800
RA
Enbrel
29,200
27,200
RA
Humira
29,700
25,900
NHL
Rituxan
25,800
36,200
BC
Herceptin
43,100
46,300
CRC
Avastin
53,500
64,700
Small molecule example
US Public price, $
EU Public price, $
0$
70,000$
 Biotech drugs are often used to combat long-term conditions such as cancer, rheumatoid arthritis, diabetes and multiple sclerosis. On average, biotech drugs cost
much more per patient than conventional (small-molecule) pharmaceuticals for treatment of chronic conditions (e.g. schizophrenia). Possible explanations are that the
manufacturing processes for the development of biotech drugs are more complex and more costly than the production of traditional pharmaceutical drugs and there is
currently no competition from copycat drugs.
*Source : IMS Padds Q4 2010
EU : average EU5
improving access
The main part of Biotech drug sales
is in highly regulated markets*
Each market has different dynamics
with pricing and reimbursement policies
going hand in hand with the regulatory
requirements. Due to inherent molecular
complexity, cost, and development
risks, biotech drug production and
commercialization in developed markets
is concentrated in the Western world.
By far, the US is the most mature market
for biotech drugs with the largest number
of products available.
Japan
9%
Europe
32%
Row
9%
US
50%
% of world market
*Source : IMS Padds MAT 2011
EU : average EU5
10
Biotech Drugs will increasingly be perceived
by payers as the main cost driver
Biotech Drugs outlook 2010 - 2020
What savings from generics?
$300
Only a few core small molecules to
potentially yield savings in the future
(Diovan, Lipitor, Seretide, Spiriva, Seroquel)
$250
+53
Billion dollars
$200
+62
$150
253
$100
200
138
Continuous price reduction of
existing generics
$50
+7.7%
2010-15 CAGR
+4,8%
2010-15 CAGR
$0
2010
2010-2015
Total pharma growth +4.5 - 5.0%
Total branded growth +0.5 - 1.1%
2015
2015-2020
2020

Savings from small molecules
to decline after 2015
Conservative estimates
Source: IMS MIDAS, MAT 12/2010
improving access
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BIOSIMILARS
What is a BioSimilar - The Teva definition
A biosimilar is a biopharmaceutical that is
physically, chemically, biologically, and clinically
similar to an approved biological reference product,
whereas generics of chemistry-based medicines are
identical copies of the original product.
Biosimilars are “similar” but not “identical” to the
originator biological medicine due to the complexity
of the active substance and the nature of the
manufacturing process, which makes it impossible
Insulin
to produce an exact copy of a biologic molecule in
the same way as a traditional chemical molecule
(generally a single molecular entity) can be copied.
As a result, manufactured drugs may vary slightly
(in drug structure and physico-chemical profile)
from the drug that was originally approved. But,
even for any innovator’s drug, batch to batch
variation is often observed. Slight variations do not
affect efficacy and safety as long as they are within
Herceptin
well-defined product specifications and
the manufacturing process is well controlled.
Biosimilars are intended to have the same
mechanism of action and are designed to treat
the same diseases as the reference product.
In this regard, key challenges lie in demonstrating
therapeutic equivalence and interchangeability
of biosimilars.
Paracetamol
Large and complex molecules
Produced by biological systems rather than chemical synthesis
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Biosimilars
are developed through a step wise process
Heterogeneity is inherent to the nature of biological
products and their manufacturing process, which
is also highly susceptible to changes (or differences)
in production conditions (e.g. purification). Since
the product and process development of biosimilars
is such a complex issue, a step-by-step process
is considered to be the most effective approach.
In the first step, it is critical to select a reference
(branded-market-approved) drug and to establish
a robust manufacturing process via quality studies
to ascertain that the physico-chemical properties
and biological characteristics of the biosimilar
and the biological reference product are completely
consistent.
When considered to be sufficiently comparable
in terms of quality, preclinical and clinical studies
are conducted to confirm the comparability of
safety and efficacy between the biosimilar and the
reference drug in a second step. These studies
should demonstrate that there are no meaningful
differences with respect to the pharmacokinetic,
pharmacodynamic, safety (with emphasis on
immunogenicity testing) and efficacy (equivalent
therapeutic efficiency) profile.
The demonstration of an acceptable level of similarity
between the biosimilar and the reference drug is
the rationale for a reduced non-clinical and clinical
data submission package.
First step
Second step
Establish a production process
that yields a product that is
completely consistent with
- physical
- chemical
- biological
Confirm comparability:
- Pre-clinical studies
- Clinical studies (PK / PD / efficacy)
product specifications of
the reference drug
 The development of a biosimilar occurs through a stepwise process. In a first step, comparability
to the reference product by evaluation of physico-chemical properties and biological
characteristics, and, in a second step, appropriately designed preclinical and clinical studies
to confirm similar efficacy and safety are required. For conventional small-molecule generic
drugs, it is sufficient to show pharmaceutical equivalence and bioequivalence in a small study
of volunteers via an abridged procedure to obtain market approval. However, the amount of data
for biosimilars will be more than for a typical generic drug application since toxicological and
other non-clinical and clinical data is needed in addition to the pharmaceutical, chemical and
biological data normally required for generic drug applications.
Source : Federal Agency for Medicines and Health Products, Biosimilars, available at: http://www.fagg-afmps.be/en/human_use/medicines/
Medicines/MA_procedures/types/Biosimilars/ (accessed 6 July 2011) World Health Organization, Guidelines on Evaluation of Similar Biotherapeutic
Products (SBPs), available at:http://www.google.be/url?sa=t&rct=j&q=%22the%20demonstration%20of%20an%20acceptable%20level%20
of%20similarity%22&source=web&cd=1&ved=0CBsQFjAA&url=http%3A%2F%2Fwww.who.int%2Fbiologicals%2Fareas%2Fbiological_
therapeutics%2FBIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf&ei=JKC3TvSYGcue-wbZ6PTSDw&usg=AFQjCNFLBbEAyjbocPGh8EcaTlq1OzZ
_0A (Accessed 6July 2011) Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus (2009) 2 [Suppl 1]: i27–i36.
improving access
Regulation for Biosimilars is in place in Europe*
and FDA released its guidance document
in February 2012
The history of regulation for biosimilars is an
exceptionally short one due to the fact that the issue
did not exist before expiry of patent protection for
many of the first-generation biotech drugs on the
market, which mainly occurred in 2004 - 2006.
The European legislation provides 10 years of market
exclusivity for innovator drugs. In the US model,
the market exclusivity provision for biologic products
is 12 years.
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Many of the first-generation biotech drugs now at
the end of their patent lives were developed originally
as orphan drugs in the US or through new Biologics
License Application.
EMA has established regulatory pathways specific
for biosimilars since 2004, while the counterpart
legislation in the US came out in February 2012.
These first biotech products were introduced
in Europe mostly through National or Deconcertation
or Mutual Recognition approval procedures prior to
the establishment of the European Medicines Agency
(EMA).
*Source : EMA
available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_
listing_000318.jsp&murl=menus/special_topics/special_topics.sp&mid=WC0b01ac0580281bf0
(accessed 07 July 2011)
Regulatory framework - EU*
The regulatory framework for biosimilars has been
established in the EU and is in place since 2005.
Biosimilars can only be authorized for use once the period
of data exclusivity on the original ‘reference’ biological
medicine has expired. The first biosimilars were approved
by the European Commission in 2006 based on
the positive scientific opinion issued by the EMA.
The EMA’s Committee for Proprietary Medicinal Products
(CPMP) and the Committee for Human Medicinal
Products (CHMP) have issued a number of guidance
documents for the development and the market approval
procedures of biosimilars.
The overarching guideline introduced the concept of
biosimilars, outlined the basic principles to be applied
and served as a ‘user guide’ to applicants on where to
find relevant scientific information in the various CHMP
guidelines. Other general guidelines can be categorized
according to their focus on quality, pre-clinical and
clinical issues. In addition, a number of product-specific
guidelines (e.g. for G-CSF) and concept papers have been
released. Finally, there are other guidelines also relevant
for biosimilars such as the immunogenicity assessment
of biotech–derived therapeutic proteins.
Post marketing surveillance to monitor immunogenicity
and potential rare adverse events is required.
Tracking product & patient safety is a key concern
of the company.
Thanks to its size and its diversity, Teva has a large
and professional Pharmaco-vigilance system in place.
Specific regulatory requirements
defined for most:
Pathway
for approving
products as
Biosimilars has
been established
“Small”
proteins
mAb
GCSF
EPO
hGH
Interferon
Insulin
General guidelines exist,
Specific regulatory requirements
currently being established
To date, > 10 products approved following the Biosimilar approval pathway
 The regulatory pathway is applied to small proteins and to more complex biologicals such as mAbs. The
EMA released draft guidelines on biosimilar medicines containing mAbs and on immunogenicity assessment of mAbs intended for in vivo clinical use for public consultation between November 2010 and May
2011. The formal guidelines are expected to be issued in the second half of 2011 and put into effect soon
afterwards.
*Source : European Medicines Agency website, Multidisciplinary: Biosimilars, available at: http://www.ema.europa.
eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&murl=menus/regulations/regulations.
jsp&mid=WC0b01ac058002958c (accessed at 11 July 2011)
improving access
Example: TevagrastimTM*
Tevagrastim®, a biosimilar medicine containing
the active substance filgrastim, stimulates the
production of white blood cells and is primarily used
to reduce the risk of infections in oncology patients
receiving chemotherapy. filgrastim is very similar
to the human protein, namely granulocyte colony
stimulating factor (G-CSF) .
In September 2008, Tevagrastim®, which was jointly
developed by TEVA and Ratiopharm, became the
first biosimilar G-CSF to be approved in the EU.
Since Tevagrastim® showed a comparable quality,
safety and efficacy profile to the reference product
Neupogen® (Amgen), the benefits were expected to
be same. Therefore, the product was approved by
the EMA and granted the entire scope of therapeutic
indications of Amgen’s Neupogen®.
The bridging principle refers to the request
for approval of a biosimilar for use in another
indication (without evidence from clinical studies in
the submission package ) based on the indications
of the reference product. These indications can be
granted by EMA through extrapolation of clinical-trial
data from one indication to another provided the
physico-chemical, biological and clinical similarity
to the reference product is demonstrated.
• EMA approved in September 2008 Tevagrastim as the first BioSimilar to Amgen’s Neupogen in Europe
• EMA granted Tevagrastim the full scope of indications of Neupogen
Bridging Principle
Submitted comparability data package with EMA
Physical
similarity
+
Chemical
similarity
+
Biological
similarity
+
Indications granted by EMA
Chemotherapy Induced neutropenia
Clinical similarity
(in relevant
setting)
Bone marrow transplantation
Chemotherapy
induced
neutropenia
extrapolation
Severe chronic neutropenia
Neutropenia in HIV patients
Stem cell mobilization
*Source : www.EMA.europa.eu/Tevagrastim
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Regulatory framework - US*
A guidance document on biosimilars
has been released by the FDA
(February 2012)
The FDA has issued the following 3 draft guidance documents pertaining
to Biosimilar product development:
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product:
The draft guidance is intended to assist companies in demonstrating that a proposed therapeutic
protein product is biosimilar to a reference product for the purpose of submitting an application,
called a “351(k)” application, to the FDA. This draft guidance describes a risk-based “totalityof-the-evidence” approach that the FDA intends to use to evaluate the data and information
submitted in support of a determination of biosimilarity of the proposed product to the reference
product. As outlined in the draft guidance, FDA recommends a stepwise approach in the
development of biosimilar products
• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product:
The draft guidance provides an overview of analytical factors to consider when assessing
biosimilarity between a proposed therapeutic protein product and a reference product for the
purpose of submitting a 351(k) application. This includes the importance of extensive analytical,
physico-chemical and biological characterization in demonstrating that the proposed biosimilar
product is highly similar to the reference product notwithstanding minor differences in clinically
inactive components.
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition
and Innovation Act of 2009:
The draft guidance provides answers to common questions from people interested in developing
biosimilar products. The question and answer format addresses questions that may arise in the
early stages of product development, such as how to request meetings with the FDA, addressing
differences in formulation from the reference product, how to request exclusivity, and other topics.
*Source : www.fda.gov./drugs/guidancecomplianceregulatoryiformation/Guidances/default/htm
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Biosimilars at teva
Teva Today
TEVA Pharmaceutical Industries Ltd. - incorporated in Israel
in 1944 - is the successor to a number of Israeli corporations,
the oldest of which was established in 1901. It is the no. 1
generic pharmaceutical company and ranks among
the top 15 pharmaceutical companies.
The company’s global presence covers North America,
Europe, Latin America, Asia and Africa. It currently has direct
operations in more than 60 countries, including 40 finished
dosage pharmaceutical manufacturing sites in 19 countries,
28 pharmaceutical R&D centers, and 21 API manufacturing
sites around the world.
TEVA manufactures and sells generic pharmaceutical products
in a variety of dosage forms, including tablets, capsules,
ointments, creams, liquids, injectable drugs and inhalants
with distribution channels to over 100 markets.
Headquartered in Israel, above 80% of TEVA’s sales,
which totaled US$18,3 billion net sales in 2011, are in
North America and Europe. TEVA has a global product
portfolio of more than 1,480 molecules and totals over
40,000 employees worldwide.
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No. 1 generic pharmaceutical company
Top 15 global pharmaceutical company
Operations in 60 countries
Distribution of products to over 100 markets
Global product portfolio of about 1,480 molecules
Approximately 40,000 employees
$18,3 billion net sales in 2011
Teva worldwide presence
With more than a century of experience in the
healthcare industry, the company enjoys a firmly
established international presence, operating through
a carefully tailored network of worldwide subsidiaries.
TEVA has a significant presence in about 60
countries, including marketing offices & distribution
centers, finished dosage pharmaceutical plants, R&D
centers, API manufacturing sites, and biosimilar
activities plants.
The majority of the subsidiaries are located
in Europe, followed by North and Latin America,
Asia and Africa.
In the 1980s, TEVA established leadership on
the Israeli market through a series of acquisitions
and joint ventures. Also during this decade,
TEVA entered the US market.
Through the 90s, TEVA continued to expand and
became a major player in the global generic market,
driven by an aggressive Merger and Acquisition
strategy both in North America and Europe.
In the 21st century, global leadership is assured
by constant search for strategic partnerships
and successful acquisitions.
60 Locations Worldwide
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The Biosimilar market has high barriers of entry
There is a higher barrier to entry for the biosimilar
market than for small-molecule generics.
Development costs for Biosimilars can be $100 to
$200 million taking 8 to 10 years for completion.
Biotech product manufacturing, in general, is
highly complex, implying the need for investments
comparable to original biologics. Both the
complexity of the clinical development and
manufacturing of biosimilars request for specialized
know-how and expertise.
TEVA’s commitment to establish the necessary
operational capabilities are three-way: increase
the manufacturing capabilities, obtain specialized
clinical development experience and regulatory
know-how, and setup a customized sales &
marketing team.
The company defined a clear long-term biosimilar
strategy and made (and will continue to make)
significant upfront capital investments to enter
the biosimilars market successfully.
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BioSimilar characteristics
Minimum requirement to play
Up to $150m per molecule
Up to 8 years development cycle
Financial scale, long-term
commitment
Capital-intensive manufacturing
Access to manufacturing capacity
Highly complex manufacturing
and development process
Specialized know-how and expertise
teva in Biosimilars
A decade of commitment & vision
It is the vision of TEVA that winning in biosimilars
requires a full set of skills. Shortest time to market
requires excellent execution of CMC development,
accurate IP navigation, and appropriate speed
of action and sense of urgency. Control of the
manufacturing cost can be achieved by establishing
solid production processes at the right scale.
Finally, customer value proposition is assured
with a broad product portfolio, and a strong focus
on affordability and availability.
Already the undisputed leader in generics for small
molecule drugs, TEVA invested heavily in biosimilars
over the last decade.
Sicor Lithuania
2000
2001
First Teva BioSimilar
activities
2002
2003
Hualida Biotech
2004
2005
Israel BioSimilar R&D
2006
FDA approves
Tev-Tropin®
Co-Genesys
2007
During these last 10 years TEVA put tremendous effort
in establishing a development (“First to market”) culture
for biosimilars lead by innovation, expertise and mindset.
Manufacturing is consolidated through in-house
quality standards. Since 2000, TEVA has entered
into several acquisition and CMO agreements, and
alliances, providing for strong internal development,
manufacturing, and R&D capabilities.
EMA approves
Eporatio®
2008
EMA approves
Tevagrastim®
2009
Ratiopharm
2010
Lonza JV
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A Global Biosimilars operation with:
26
strong R&D capabilities
strong development
and manufacturing capabilities
strong technology
Teva Israel Biotechnology R&D (Israel)
Sicor Biotech (Lithuania)
Teva Biopharmaceuticals (USA)
Development of BioSimilar mAb’s. (product characterization /
cell line construction / process development)
Development / production of BioSimilars in microbial systems
(e.g. GCSF, Interferon) / formulation development
A unique half-life extension technology :
Recombinant Albumin Fusion
The leader of the biotech pharmacy in Lithuania,
SICOR Biotech, has been working in the field of
advanced biotechnology for over 20 years now and
is the only company in Central and Eastern Europe
developing and producing high-tech recombinant
biopharmaceuticals. In 2004, the company joined
the TEVA group.
The acquisition of COGENESYS in 2008 further
expanded TEVA’s biopharmaceutical pipeline
and provided access to the recombinant albumin
fusion technology. This technology enables the
development of Long Acting biotech drugs and
additional protein-based medicines across broad
therapeutic categories.
Through the SICOR acquisition, TEVA now has
plants in Mexico, China and Latvia that develop,
manufacture, and market biosimilar materials,
e.g. G-CSF, interferon alpha 2B and human
growth hormone.
The clinically validated albumin-fusion technology
offers a number of advantages, including the
ability to improve the bioavailability of existing
biotech drugs and increased feasibility of
developing pharmaceutically relevant peptides.
strong alliances
extended development
and manufacturing capabilities
JV with Lonza (Switzerland)
TL Biopharmaceuticals Access to the world’s largest
commercial scale mAb manufacturing infrastructure
Ratiopharm group (Germany)
Development / production of BioSimilars in mammalian
systems (e.g. EPO, FSH) / glycPEGylation technology
Headquartered in Basel, Switzerland LONZA
Group Ltd. is one of the world leaders in
exclusive contract manufacturing of monoclonal
antibodies and recombinant proteins using
mammalian cell culture.
In 2010, TEVA has completed its acquisition
of Germany’s RATIOPHARM, strengthening its
position in Europe’s growing generics market.
The internationally oriented generic business,
the development and sales of biotech
preparations, combined with highly efficient,
modern production, are the main pillars
of the RATIOPHARM group.
Combined with TEVA’s global leadership
and expertise in clinical development and
marketing of generics, the joint venture
generates significant opportunities and benefits
for both companies.
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BioSimilars@Teva
A recipe for success
The core elements of TEVA’s strategy are three-ways:
development culture, manufacturing infrastructure
and customer value proposition.
The company’s development culture focuses on
improving generic R&D capabilities and production
capacity, high value first-to-market opportunities as well
as leveraging the broad product portfolio to enhance
the global market position. Developing innovative drugs
28
involves different processes and expertise than ever
relied upon in the development of generic drugs.
TEVA believes that continuing to invest, either directly
or in partnership with others, in the technologies,
infrastructure and capabilities is necessary to
develop and produce affordable biopharmaceuticals,
including biosimilars. Because of the amounts
required to be invested in augmenting the innovative
pipeline, TEVA is increasingly reliant on partnerships
and joint ventures with third parties.
Finally, customer value is achieved by broadening
the product portfolio and executing more new
product launches, optimizing the global supply chain,
helping customers more efficiently manage their
inventory and customizing shipping methods based
on specific customer needs.
TevaBioSimilars
Development
Culture
• Fully integrated Development System
• Innovative + Generic expertise
• IP navigation capabilities
• “First to market” Culture
TevaBioSimilars
Manufacturing
• In-house Quality Manufacturing
• Broad CMO agreements
• Lonza JV
TevaBioSimilars
Customer Value
Proposition
• “Making better Health Care accessible around the World”
• Wide range of Biosimilars and Follow-on
Biologics in development
Notes
improving access
Notes
„Improving access to life saving treatments“
www.tevapharm.com