للها مسب نمحرلا میحرلا -...
TRANSCRIPT
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بسم اهلل الرحمن الرحیم
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Biosimilars & Biobetters
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What is a biologic drug?
Biologic drugs is a medicine whose active substance is made by
or derived from a living organism.
The first recombinant proteins to be produced - in the 1970s
and 1980s - were insulin and growth hormone.
These biologic drugs range from the simpler and smaller, often
non-glycosylated proteins, such as insulin or growth hormone to
the much more complex and larger biologic drugs, including
glycoproteins and monoclonal antibodies.
E. coli bacterium producing interferon gamma
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What is a biosimilar medicine?
The term biosimilar refers to products that are marketed after
expiration of patents, which are claimed to have similar
properties to existing biologic products.
Due to the complexity of biologics, a product can only be
made that is similar, but not identical.
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Terminology
Similar biological medicinal product (EMA)
Biosimilar (EMA)
Subsequent entry biologic (Canada)
follow-on biologic (FDA, Japan)
Follow-on protein product (FDA)
Iran?
به فرآروده بیولوژیکی اطالق می : داروهای مشابه بیولوژیکشود که دارای ماده موثره یکسان با داروی اختصاصی اصلی
بوده و از لحاظ کیفیت، ایمنی و اثربخشی مشابه داروی .اختصاصی اصلی و قابل جایگزینی درمانی با آن باشد
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Other related terms
Generic
This is a small-molecule drug whose active substance is shown by
appropriate testing to have identical physicochemical, preclinical
and clinical properties to an originator small-molecule drug.
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Other related terms
Biobetters : These are drugs that are similar to innovator
biologics but are characterized by some change in the
structure of the protein or the process by which they are made,
with the goal of improved efficacy, safety or immunogenicity.
A major advantage to manufacturers of biobetters is the fact
that they have lower early-stage R & D costs compared to
originator drugs.
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Biosimilars vs. Biobetters
More incentives exist to develop biobetters than biosimilars,
particularly in the US.
Companies may be inclined to develop biobetters rather than
biosimilars for a number of reasons.
They are new biologics, rather than copies of old ones.
Biobetters will also command a higher price than a biosimilar
would. the improved function of the drug will add value to
what is currently available on the market.
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Why do biological medicines differ
from chemical medicines?
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How are biological medicines
manufactured?
Production of the cells Production of the master cell bank
The exact DNA sequence and the
type of host cell used will
significantly influence the
characteristics of the product
No two master cell banks are
exactly alike
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How are biological medicines
manufactured?
The conditions under which cells
are cultured can affect the
nature of the end product.
Purifying the protein
Cell fermentation
Any change in the purification process can
affect the clinical characteristics of the
product
Production and purification of biopharmaceuticals is
a complicated process
• Small molecule pharmaceutical: < 100 quality tests
• Biopharmaceutical: > 2000 tests
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MethodsAttributes
IE, HPLC, gel electrophoresisPrimary sequence (peptide map and amino acid
sequence analysis), immunogenicity
(immunoassay) other identity indicators
Cell-based bioassay, gene expression bioassay, ADCC, CDCPotency
Near/far UV circular dichroism spectroscopy, Fourier transform infrared,
spectroscopy, X ray crystallography and differential scanning calorimetry
Conformation
Monosaccharide composition analysis, oligosaccharide profile, CE, LC-MS, MS/MS,
ESI, MALDI-TOF
Glycosylation
Peptide mapping with MSPhosphorylation
SE-HPLC, gel electrophoresis, AUC, peptide mapping with MS, RP HPLCTruncation
Peptide mapping with (MS, HPLC), methylation, isomerization (RP HPLC)Glycation
SE-HPLC, gel electrophoresis, Light scattering and AUCAggregation
Peptide mapping with MSOxidation
Capillary IEF, peptide mapping with MS, and CEX-HPLCDeamidation
ELISA, DNA, endotoxin (Limulus amebocyte lysate assay)Host cell proteins
Cell assays, spectroscopy, ELISABinding
Cell assays, animal modelsBiological activity
Analysis
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Formulation
Formulation is a key step in stabilizing the protein.
The components of the formulation, and the process
used, can significantly affect the product’s behavior
in patients.
Example: Pure Red Cell Aplasia (PRCA) associated
with EPO treatment Removal of human serum albumin stabilizer
from epoetin alfa
Number of Epoetin Alfa PRCA Cases
year
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Formulation
In 1998, HSA was replaced with polysorbate 80 in prefilled
syringes of Eprex®
Factors potentially contributing to the immunogenicity of Eprex ®
• Formation of micelles associated with Epoetin
• Silicon droplets in the pre-filled syringes
• Leachates from rubber stoppers
• Mishandling
Source : N Engl J Med 2004;351:1403-8.
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Biosimilars and immunogenicity
• Current analytical methods cannot fully predict biological
properties
• The immune system can detect alterations in products
missed by analytical methods
• Antibodies against the biopharmaceuticals could have
serious clinical consequences
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Factors influencing immunogenicity
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An immunoblot of different interferon-
ß-1a products
HSA
IFNβ
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Timeline for development of a
biosimilar medicine
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Biosimilars guidelines
Biosimilars
guidelines
WHO
Europe
USA
Other countries
Iran
• The concept of biosimilars defined.
• Biosimilars guidelines issued.
• The concept of biosimilars
defined.
• Biosimilars guidelines issued.
• The concept of biosimilars defined.
• Biosimilars guidelines issued.
• Obama government plans to support
biosimilars.
• The definition and guidelines of
biosimilars in preparation.
• Draft guidelines on biosimilars
prepared in Japan, China, Turkey,
Malaysia and Taiwan.
• Biosimilars guidelines being
prepared in other countries.
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(European Medicines Agency (EMA
European Medicines Agency (EMA) was the first
Regulatory authority to specially adapt its approval procedure
to authorize subsequent versions of previously approved biologics,
which are termed “similar biological medicinal products” or for
short, often called biosimilars.
This procedure is based on a thorough demonstration of
“comparability” of the “similar” product to an existing approved
product.
Guidelines for production, characterization, preclinical and clinical
studies and registration of these products have been issued.
EMA plans to revise biosimilar guidelines.
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comparability of the biosimilars
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World Health Organization
(WHO)
The World Health Organization (WHO)
also got involved and issued draft of Guidelines on
Evaluation of Similar Biotherapeutics (SBPs). These
were finalized on October 2009.
Based on WHO guidelines, some regulatory
authorities such as Malaysia, Singapore, Republic of
Korea, Turkey, Saudi Arabia, Japan, Brazil, South
Africa, Jordan, Mexico and Iran have prepared
guidelines for registration of these medicinal products.
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Draft guideline biosimilars WHO
• Quality
• Non-clinical evaluation
• Clinical evaluation
• Pharmacovigilance
• Prescribing information and label
A reference biotherapeutic product (RBP) is used as the comparator for head-to-head comparability studies with the similar biotherapeutic product (SBP) in order to show similarity in terms of quality, safety and efficacy.(The principles of such studies are described in relevant ICH guidelines)
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International Conference on
Harmonisation
Harmonisation of regulatory requirements was pioneered by
the European Community (EC), in the 1980s, as the EC (now the
European Union) moved towards the development of a single
market for pharmaceuticals. The success achieved in Europe
demonstrated that harmonisation was feasible. At the same
time there were bilateral discussions between Europe, Japan
and the US on possibilities for harmonisation. It was, however,
at the WHO Conference of Drug Regulatory Authorities
(ICDRA), in Paris, in 1989, that specific plans for action began
to materialise.
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ICH guidelines
• International Conference on Harmonisation – Efficacy
ICH E (For pharmacovigilance planning ICH E2E)
• International Conference on Harmonisation - Joint
Safety/Efficacy (Multidisciplinary)
ICH M (ICH M6 for gene therapy)
• International Conference on Harmonisation – Quality
ICH Q (For changes in the manufacturing process ICH Q5E)
• International Conference on Harmonisation – Safety
ICH S (ICH S6 Guideline for non-cilinilal study)
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US
The BPCI Act is part of the healthcare reform
legislation, which was signed into law on 23 March
2010 by President Barack Obama. The BPCI Act
establishes an abbreviated approval pathway for
biological products that are demonstrated to be
‘highly similar’ (biosimilar) to, or ‘interchangeable’
with, an FDA-licensed biological product.
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Iran
• Until 2002, there were no specific instructions or guidelines for
production and registration of biological medicinal products,
nor recombinant proteins. All the relevant documents have
been prepared in the period of 2002-2010.
• The Iran NRA prepared a draft guideline on the registration of
biosimilars based on the WHO draft guideline of 2009. This
was revised in two steps based on WHO draft guideline
changes. It has been finalized and approved in September
2010 by the Iran expert committee on biologicals and as the
last step approved by the Head of the Iran FDA in February
2011.
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Biosimilars guidelines in Iran
The framework of the guideline is very similar to the WHO
guideline and consists of the following sections:
a) Introduction and Scope: definition of biosimilars, original brand, registration
process and general consideration
b) Quality: production process, characterization( physiochemical, biological activity,
immunochemical, accelerated stability test), specifications, analytical techniques, stability
c) Non clinical evaluation
d) Clinical evaluation: pharmacokinetic/pharmacodynamic studies, efficacy studies,
safety and immunogenicity
e) Pharmacovigilance
f) Prescription and labeling information
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Product name* Active ingredient Therapeutic area Company Reference product Originator company
AryoSeven anti-haemophilic factor VII
(human)
Haemophilia
Von Willebrand disease
AryoGen Alphanate/ Hemofil M/
Koate-DVI/ Monoclate-P
Grifols/
Baxter/
Kedrion Biopharma
Arvestin bevacizumab Cancer AryoGen Avastin Roche
CinnaFact Buserelin acetate Advanced prostate cancer (stage D)
Endometriosis
CinnaGen Suprefact sanofi-aventis
Epolyrec epoetin alpha Anaemia
Cancer
Chronic kidney failure
Pasteur Institute of Iran
Poyesh Daro
Recpharma
Erypo Janssen-Cilag
Betapoietin epoetin beta Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure
CinnaGen Zahravi Neorecormon Roche
Altebrel etanercept Arthritis
Psoriasis
AryoGen Enbrel Pfizer
PDgrastim Filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
Poyesh Daro Neupogen Amgen
hepatitis B vaccine Hepatitis B Pasteur Institute of Iran Recombivax HB/
Engerix-B
Merck/GSK
PDferon-B interferon alpha Antitumour
Chronic hepatitis C
Leukaemia
Pasteur Institute of Iran
Poyesh Daro
IntronA Merck Sharp & Dohme
Cinno Vex interferon beta 1a Multiple sclerosis CinnaGen Avonex/Rebif Biogen Idec/ Merck Serono
ReciGen interferon beta 1a Multiple sclerosis CinnaGen Avonex/Rebif Biogen Idec/ Merck Serono
Ziferon interferon beta 1b Multiple sclerosis Zistdaru Danesh Betaferon/ Betaseron/
Extavia
Bayer Healthcare/ Novartis
Immunex interferon gamma Chronic granulomatous disease (CGD)
Severe, malignant osteopetrosis
Recpharma Actimmune Vidara Therapeutics
Cinno Par parathyroid hormone Osteoporosis CinnaGen Forteo Eli Lilly
Pegaferon peg-interferon alpha Chronic hepatitis C Poyesh Daro PEG-Intron Schering-Plough
Reditux/
Zitux
Rituximab Rheumatoid arthritis
Non-Hodgkins lymphoma
Leukaemia
CinnaGen/AryoGen MabThera Roche
Hebreastin trastuzumab Stomach neoplasms
Breast neoplasms
AryoGen Herceptin Roche
*product names given where available
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Growth barriers for the biosimilars market
Uncertainties in regulatory frameworks and greater manufacturing
and clinical development complexities have limited the growth of the
biosimilars market
• Complex regulations
• Currently long approval times
• The US (the largest biologics market) just recently introduced a legislative framework for biosimilar
Regulatory framework
• Manufacturing is complex
• Higher costs for pre-clinical and clinical studies
Higher manufacturing complexity and
cost
• Biosimilars are not granted automatic substitution
• Traditionally, physicians opposed to biosimilars on efficacy and safety grounds
Physicians reluctance to
prescribe
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Biosimilars prescribing and uptake
PHYSICIAN CONCERNS
• Safety and efficacy concerns
• Lack of information
• Lack of experience
• Inability to establish trust
Outcome:
Modest sales of
Biosimilars
Lack of experience and concerns on safety and efficacy of
biosimilars have acted as barriers to widespread physician
acceptance
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Growth drivers for the biosimilars market
• Biologics have managed to leverage higher prices
• Prices of biosimilars are approximately 20-30% lower than the original biologics
Healthcare cost savings
• Continuing expiry of biologics patents
• More companies are expected to enter biosimilarspace
Biologics patent expiry
• Higher rate of approval of biosimilars
Increased regulatory approvals
Potential cost savings for healthcare providers and patent
expiry of blockbuster biologics are the key drivers
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Global Biosimilars Market Forecast,
2010-2021
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Number and value of biologic drugs set to lose
patent protection per year through 2015
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Estimates for the biosimilars market
(2015)
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Key success factors for biosimilars players
The capabilities needed for success in the biosimilars market are
significant and will limit the number of entrants in the near to mid term
Manufacturing capabilities
Clinical development experience and
regulatory know-how
Customized sales & marketing skills
Key s
ucc
ess
fact
ors
Manufacturing process
Tests to control quality
Select the right molecule (high sales potential)
Infrastructure and knowledge for clinical
trials
Deep understanding of regulatory
guidelines
Customized sales and marketing team
Continuous scientific communication and
marketing activities
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Monoclonal Antibodies Market Forecast
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Patent Expiries for Leading Monoclonal
Antibodies 2011-2021
EU Patent
Expiry
US Patent
Expiry
CompanyDrug
20142014J&J/Merck &
Co/Mitsubishi Tanabe
Remicade
(infliximab)
20192017RocheAvastin
(bevacizumab)
20132015Roche/Biogen IdecMabThera
(rituximab)
20142014RocheHerceptin
(trastuzumab)
20142014Eli Lilly/BMS/Merck KGaAErbitux
(cetuximab)
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Reditux: The World's First Biosimilar
Monoclonal Antibody
Dr. Reddy's launched the world's first biosimilar monoclonal antibody, Reditux (rituximab), in India in April 2007.
The drug is a biosimilar of Genentech's and Roche's rituximab, marketed as Rtuxan by Genentech and Biogen Idec in markets including the US and MabThera by Roche in many other international markets.
Dr. Reddy's reportedly spent more than $10m developing Reditux, with the drug achieving approximately $3m in sales in its first year.
Dr. Reddy's apparently markets Reditux at about half the price of MabThera. That situation has reportedly forced Roche to lower the recommended price of its product in India.
Growth in sales will be slow, however, as sales for the year ended 31 March 2010 were reportedly only $4m, representing a CAGR of 15.5%.
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Thank you, any question?