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Biosimilars, Orphan Drugs, Advanced Therapy Medicines:
Current regulatory issues (EU/US)
Michalopoulou & Associates | 40 Ag. Konstantinou st. | “Aithrio” Business Center (Α 16-18) | 15 124 Marousi Athens Greece
T : +30 210 330 52 30 | F : +30 210 330 52 32 | info@lawgroup.gr | www.lawgroup.gr
Maroussi Plaza, Dec 3rd 2015
“No other sector holds the promise to
enhance quality of life, productivity and
environmental sustainability through
innovation like biotechnology, while also
benefitting Europe’s economy and research
base”.
Biotechnology at a Glance
Carlo Incerti, Chairman of EuropaBio,
3rd EuropaBio event on the Benefits of
Biotechnology, Brussels, 23 June 2015
Biotechnology at a Glance
Presentation Overview
Foci Biotechnology
Orphan Medicinal Products
Αdvance Therapy Medicinal Products
 Biosimilars
 Compliance issues
 Biotech Jurisprudence
The Future
Biotechnology at a Glance
RED BIOTECH
(or Medical Biotech)
applied to manufactured pharmaceuticals
like enzymes, antibiotics and vaccines
and its use for molecular diagnostic
GREEN BIOTECH
(or Agricultural Biotech)
applied to agricultural processes
or products
BLUE BIOTECH
(or Marine Biotech)
applied to marine or aquatic
applications
of biotechnology
WHITE BIOTECH
(or Industrial Biotech)
applied to industrial
or other production processes
BIOTECHNOLOGY
Medical Biotechnology: Why?
350 million patients
benefit from direct
use of biotech
medicine to treat and
prevent chronic
illnesses- heart
attacks, leukemia,
diabetes, hepatitis &
rare diseases
Healthcare Biotech enables citizens to live healthier, longer
lives by providing more medical choices & solutions!
Orphan Medicinal products
Orphan medicinal products - Major developments
1999: “Orphan Regulation” (EC) No 141/2000 on orphan medicinal products
introduced incentives for the research, development and marketing of medicinal products
for rare diseases
2003: “EC’s Communication” on Regulation (EC) No 141/2000 on specific matters
involving the designation and market exclusivity provisions of the Orphan Regulation
 NEW! 16/11/2015-16/2/2016: EC’s Review Process of the Orphan Regulation (EC) of a
Public Consultation with stakeholders
“Notice” focusing on the application of Articles 3, 5 and 7 of the Orphan Regulation
Orphan Medicinal products
 Significant benefit: clarification of what
constitutes a ‘significant benefit’
 encouraging the development of orphan
products for communicable diseases (e.g. Ebola)
 reassessment of the orphan criteria for a new
subset of the condition when a sponsor extends
the use of its product after marketing
authorization
 clarifications on the transfer of orphan
designations between sponsors & fair conditions
of competition among companies
http://ec.europa.eu/health/human-use/orphan-medicines/developments/index_en.htm
Contributions may be sent by e-mail to:
SANTE-PHARMACEUTICALS-D5@ec.europa.eu
Biotechnology & Pioneering role in science
Vinciane Pirard, M.D.
Co-Chair EFPIA-EuropaBio Joint Task Force
on Orphan Medicines and Rare Diseases
A decade ago, the treatment of CML had been
dramatically changed by tyrosine kinase inhibitors
(TKIs)
Before the introduction of this novel medicine, only
30% percent of CML patients survived to 5 years
after diagnosis.
Nowadays the overall survival rate at 5 years is
85%–95%.
http://www.leukemia-net.org/content/home/index_eng.html
Advance Therapy Medicinal products
Advance Therapy Medicinal products
gene therapy for cancer, adult cell stem
therapy, or tissue-engineered medicinal
products fall under:
 Regulation (EC) 1394/2007 provides the
overall framework on ATMPs
Tissue Engineering
 Cell Therapy
 Gene Therapy
Advance Therapy Medicinal products
http://www.esgct.eu/News-and-Events/News.aspx?ID=10049
Biosimilar products
EMA: A similar biological or 'biosimilar' medicine is a
biological medicine that is similar to another biological
medicine that has already been authorized for use.
Biological medicines are medicines that are made by or
derived from a biological source, such as a bacterium or
yeast.
 EU Guideline, April 30th 2015
Biosimilar: “highly similar to the reference medicinal
product in physicochemical and biological terms”
Biosimilars can only be authorized for use once the period
of data exclusivity on the original 'reference' biological
medicine has expired. In general, this means that the
biological reference medicine must have been authorized
for at least 10 years (8+2+1) before a similar biological
medicine can be made available by another company
FDA: evaluates biosimilar interchangeability
≠
EMA: interchangeability rests with the EU member states
SOS Interchangeability
(safety, efficacy & quality): Major
Biggest Challenge for Litigation
Biotechnology & Compliance
TRANSPARENCY & BIG DATA: Legal Issues that
Biotech companies should address
• Clinical trials will now require stronger legal protection
By requiring firms under the new legislation to publish their full
clinical trials data as part of the approval procedure, novel
indications are often revealed. It can be difficult to patent a further,
significant use of the drug at a later date, as the positive new effect
has already been made public and is therefore not new or has
become obvious.
• Not just Personal Data. Informed Consent
The Personal Genome Project has redefined “informed consent”
by requiring a perfect score on a test before participants can even
enter their name.
Sage Bionetworks, a non-profit organization and Lookout a
mobiles security firm have taken a similar approach and present
users with interactive policy forms to provide consent.
→ flexibility in designing regulatory exclusivity periods
→ strengthening communication and collaboration between the
relevant stakeholders
http://www.sciencedaily.com/releases/2015/07/150713095308.htm
Biotechnology & Compliance
Biotechnology complicated legal issues:
-Gaps in Legislation US & Europe
-Strong IP protection is essential
The necessary framework to address the issues:
-Robust & predictable regulatory approval system
-Regulatory system matching scientific progress
-EU healthcare need to ensure that effective
innovative treatments are approved and
reimbursed
Biotechnology & Litigation
CJEU Stem Cell Patents Decision – Brüstle v Greenpeace (C-34/10)
Dr. Oliver Brüstle is a German neuropathologist from the University of Bonn who, in
September 1997, successfully applied for a patent regarding the isolation and
production of neural precursor cells, as extracted from embryonic stem cells
originating from Israel. In 2004, the environmental activist group Greenpeace filed suit
challenging the validity of the patent, claiming that because the stem cells extracted by
Dr. Brüstle originally came from human embryos, such practice went against notions of
ordre public as codified in E.U. and domestic law.
Questions raised regarding the meaning of the Biotech Directive (art.5, 6):
-“Human Embryo”: when human body begins to develop?
- Use of human embryos for industrial/commercial purposes: exception for scientific
research?
• Non direct utilisation of human embryos: Materials or ingredients obtained by the
prior destruction of human embryos
→ invention non-patentable if any of the necessary steps result to the destruction or
is used in the destruction of future embryos
…Judging EU Patents’ Morality? ≠ US no such restrictions on stem cell research
Biotechnology & Litigation
CJEU International Stem Cell Corporation vs. Controller General of Patents (C-364/13)
International Stem Cell Corporation, a biotechnology company in Carlsbad, California,
challenged the judgement after an application it made in the United Kingdom for two
patents was rejected. The patents covered methods to generate corneal tissue from ES
cells that had been made from egg cells, or ova, through parthenogenesis.
International Stem Cell, however, uses processes based on unfertilized human eggs.
EU Court: An organism which is incapable of developing into a human being does not
constitute a human embryo within the meaning of the Biotech Directive.
Accordingly, uses of such an organism for industrial or commercial purposes may, as a
rule, be patented!
Pending Bioethical questions…
Biotechnology: Our FUTURE
Fascinating news…
In 2013 the US Food and Drug
Administration (FDA) ordered 23andMe to
discontinue marketing its personal genome
service (PGS) as the company had not obtained
the legally required regulatory approval
resulting in concerns about the potential
consequences of customers receiving
inaccurate health results. The company
continued to sell a personal genome test
without health-related results in the United
States until October 21, 2015, when it
announced that it would be including a
revised health component with FDA approval.
Based on a sample of saliva, the health-related
service will now offer carrier data for
36 genetic diseases, such as sickle cell anemia
and cystic fibrosis, ancestry information,
and predisposition tests to wellness
and trait characteristics. It will not, however,
indicate whether a person may have adverse
reactions to certain drugs or test for common
conditions–
including breast and ovarian cancer,
Alzheimer's and heart disease –
like the company's previous offering.
BREAKTHROUGHS in the LAB are driving BIG RETURNS
The Nasdaq Biotechnology index has nearly quintupled over
the past decade and returned 34% last year alone,
easily eclipsing the S&P 500’s gain of 11% for 2014.
Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (EU/US)

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Biosimilars, Orphans, Advanced Therapy Medicines: Current regulatory issues (EU/US)

  • 1. Biosimilars, Orphan Drugs, Advanced Therapy Medicines: Current regulatory issues (EU/US) Michalopoulou & Associates | 40 Ag. Konstantinou st. | “Aithrio” Business Center (Α 16-18) | 15 124 Marousi Athens Greece T : +30 210 330 52 30 | F : +30 210 330 52 32 | info@lawgroup.gr | www.lawgroup.gr Maroussi Plaza, Dec 3rd 2015
  • 2. “No other sector holds the promise to enhance quality of life, productivity and environmental sustainability through innovation like biotechnology, while also benefitting Europe’s economy and research base”. Biotechnology at a Glance Carlo Incerti, Chairman of EuropaBio, 3rd EuropaBio event on the Benefits of Biotechnology, Brussels, 23 June 2015
  • 3. Biotechnology at a Glance Presentation Overview Foci Biotechnology Orphan Medicinal Products Αdvance Therapy Medicinal Products  Biosimilars  Compliance issues  Biotech Jurisprudence The Future
  • 4. Biotechnology at a Glance RED BIOTECH (or Medical Biotech) applied to manufactured pharmaceuticals like enzymes, antibiotics and vaccines and its use for molecular diagnostic GREEN BIOTECH (or Agricultural Biotech) applied to agricultural processes or products BLUE BIOTECH (or Marine Biotech) applied to marine or aquatic applications of biotechnology WHITE BIOTECH (or Industrial Biotech) applied to industrial or other production processes BIOTECHNOLOGY
  • 5. Medical Biotechnology: Why? 350 million patients benefit from direct use of biotech medicine to treat and prevent chronic illnesses- heart attacks, leukemia, diabetes, hepatitis & rare diseases Healthcare Biotech enables citizens to live healthier, longer lives by providing more medical choices & solutions!
  • 6. Orphan Medicinal products Orphan medicinal products - Major developments 1999: “Orphan Regulation” (EC) No 141/2000 on orphan medicinal products introduced incentives for the research, development and marketing of medicinal products for rare diseases 2003: “EC’s Communication” on Regulation (EC) No 141/2000 on specific matters involving the designation and market exclusivity provisions of the Orphan Regulation  NEW! 16/11/2015-16/2/2016: EC’s Review Process of the Orphan Regulation (EC) of a Public Consultation with stakeholders “Notice” focusing on the application of Articles 3, 5 and 7 of the Orphan Regulation
  • 7. Orphan Medicinal products  Significant benefit: clarification of what constitutes a ‘significant benefit’  encouraging the development of orphan products for communicable diseases (e.g. Ebola)  reassessment of the orphan criteria for a new subset of the condition when a sponsor extends the use of its product after marketing authorization  clarifications on the transfer of orphan designations between sponsors & fair conditions of competition among companies http://ec.europa.eu/health/human-use/orphan-medicines/developments/index_en.htm Contributions may be sent by e-mail to: SANTE-PHARMACEUTICALS-D5@ec.europa.eu
  • 8. Biotechnology & Pioneering role in science Vinciane Pirard, M.D. Co-Chair EFPIA-EuropaBio Joint Task Force on Orphan Medicines and Rare Diseases A decade ago, the treatment of CML had been dramatically changed by tyrosine kinase inhibitors (TKIs) Before the introduction of this novel medicine, only 30% percent of CML patients survived to 5 years after diagnosis. Nowadays the overall survival rate at 5 years is 85%–95%. http://www.leukemia-net.org/content/home/index_eng.html
  • 9. Advance Therapy Medicinal products Advance Therapy Medicinal products gene therapy for cancer, adult cell stem therapy, or tissue-engineered medicinal products fall under:  Regulation (EC) 1394/2007 provides the overall framework on ATMPs Tissue Engineering  Cell Therapy  Gene Therapy
  • 10. Advance Therapy Medicinal products http://www.esgct.eu/News-and-Events/News.aspx?ID=10049
  • 11. Biosimilar products EMA: A similar biological or 'biosimilar' medicine is a biological medicine that is similar to another biological medicine that has already been authorized for use. Biological medicines are medicines that are made by or derived from a biological source, such as a bacterium or yeast.  EU Guideline, April 30th 2015 Biosimilar: “highly similar to the reference medicinal product in physicochemical and biological terms” Biosimilars can only be authorized for use once the period of data exclusivity on the original 'reference' biological medicine has expired. In general, this means that the biological reference medicine must have been authorized for at least 10 years (8+2+1) before a similar biological medicine can be made available by another company FDA: evaluates biosimilar interchangeability ≠ EMA: interchangeability rests with the EU member states SOS Interchangeability (safety, efficacy & quality): Major Biggest Challenge for Litigation
  • 12. Biotechnology & Compliance TRANSPARENCY & BIG DATA: Legal Issues that Biotech companies should address • Clinical trials will now require stronger legal protection By requiring firms under the new legislation to publish their full clinical trials data as part of the approval procedure, novel indications are often revealed. It can be difficult to patent a further, significant use of the drug at a later date, as the positive new effect has already been made public and is therefore not new or has become obvious. • Not just Personal Data. Informed Consent The Personal Genome Project has redefined “informed consent” by requiring a perfect score on a test before participants can even enter their name. Sage Bionetworks, a non-profit organization and Lookout a mobiles security firm have taken a similar approach and present users with interactive policy forms to provide consent. → flexibility in designing regulatory exclusivity periods → strengthening communication and collaboration between the relevant stakeholders http://www.sciencedaily.com/releases/2015/07/150713095308.htm
  • 13. Biotechnology & Compliance Biotechnology complicated legal issues: -Gaps in Legislation US & Europe -Strong IP protection is essential The necessary framework to address the issues: -Robust & predictable regulatory approval system -Regulatory system matching scientific progress -EU healthcare need to ensure that effective innovative treatments are approved and reimbursed
  • 14. Biotechnology & Litigation CJEU Stem Cell Patents Decision – Brüstle v Greenpeace (C-34/10) Dr. Oliver Brüstle is a German neuropathologist from the University of Bonn who, in September 1997, successfully applied for a patent regarding the isolation and production of neural precursor cells, as extracted from embryonic stem cells originating from Israel. In 2004, the environmental activist group Greenpeace filed suit challenging the validity of the patent, claiming that because the stem cells extracted by Dr. Brüstle originally came from human embryos, such practice went against notions of ordre public as codified in E.U. and domestic law. Questions raised regarding the meaning of the Biotech Directive (art.5, 6): -“Human Embryo”: when human body begins to develop? - Use of human embryos for industrial/commercial purposes: exception for scientific research? • Non direct utilisation of human embryos: Materials or ingredients obtained by the prior destruction of human embryos → invention non-patentable if any of the necessary steps result to the destruction or is used in the destruction of future embryos …Judging EU Patents’ Morality? ≠ US no such restrictions on stem cell research
  • 15. Biotechnology & Litigation CJEU International Stem Cell Corporation vs. Controller General of Patents (C-364/13) International Stem Cell Corporation, a biotechnology company in Carlsbad, California, challenged the judgement after an application it made in the United Kingdom for two patents was rejected. The patents covered methods to generate corneal tissue from ES cells that had been made from egg cells, or ova, through parthenogenesis. International Stem Cell, however, uses processes based on unfertilized human eggs. EU Court: An organism which is incapable of developing into a human being does not constitute a human embryo within the meaning of the Biotech Directive. Accordingly, uses of such an organism for industrial or commercial purposes may, as a rule, be patented!
  • 17. Biotechnology: Our FUTURE Fascinating news… In 2013 the US Food and Drug Administration (FDA) ordered 23andMe to discontinue marketing its personal genome service (PGS) as the company had not obtained the legally required regulatory approval resulting in concerns about the potential consequences of customers receiving inaccurate health results. The company continued to sell a personal genome test without health-related results in the United States until October 21, 2015, when it announced that it would be including a revised health component with FDA approval. Based on a sample of saliva, the health-related service will now offer carrier data for 36 genetic diseases, such as sickle cell anemia and cystic fibrosis, ancestry information, and predisposition tests to wellness and trait characteristics. It will not, however, indicate whether a person may have adverse reactions to certain drugs or test for common conditions– including breast and ovarian cancer, Alzheimer's and heart disease – like the company's previous offering. BREAKTHROUGHS in the LAB are driving BIG RETURNS The Nasdaq Biotechnology index has nearly quintupled over the past decade and returned 34% last year alone, easily eclipsing the S&P 500’s gain of 11% for 2014.