At least 400 million people worldwide lack access to essential health services and 2 billion cannot afford the medicines they need. Meanwhile, the global cost of healthcare has jumped to 6.5 trillion US dollars. Access is a huge and complex issue, which affects both developing and developed countries.
Today Carol Lynch, our Global Head of Biopharmaceuticals, gave a keynote address to the European Biosimilars Group highlighting how biosimilars can help transform patient outcomes and calling for all stakeholders to work together to build trust and confidence. You can read the presentation here
“Challenges of biosimilar product development and experience gained”
Shows the development process for biosimilars, focusing specifically on the company’s experience
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of biosimilars, ease in development and a quick approval process are some key driving factors that drive the growth of this market. Effective and timely formulated regulations facilitate the viability and balance between original and biosimilar products. Moreover, a favorable regulatory environment and the establishment of IPR protections are factors that boost the market growth.
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
“Challenges of biosimilar product development and experience gained”
Shows the development process for biosimilars, focusing specifically on the company’s experience
Dialogue with Canada’s leading regulatory and assessment experts: Health Canada Bureau of Biologics and Genetic Therapies (BGTD) and Canadian Agency for Drugs and Technologies in Health (CADTH)
Date: June 29, 2016
Time: 1:00pm to 3:00pm EST
Biosimilars or follow-on-biologics are highly similar versions of reference biologics derived from living organisms such as plants and animals. The development of biosimilars and validation with reference biologics play a significant role in the commercialization of biosimilars. Economic pricing of biosimilars, ease in development and a quick approval process are some key driving factors that drive the growth of this market. Effective and timely formulated regulations facilitate the viability and balance between original and biosimilar products. Moreover, a favorable regulatory environment and the establishment of IPR protections are factors that boost the market growth.
Currently, when a patient wants to be treated for a pathology, depending on the country, a doctor or a pharmacist can propose different types of drug: an originators, a generic or a biosimilar with the aim of bringing the best solution to the patient.
In the same time, authorities, learning societies, patient associations, national and European unions work closely together to set up regulations that will help bring the most efficient drugs at the lowest price on the market and take care of the patient.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
http://www.indxx.com/indices.php?id=211 - Thus far in the 21st century, the rise of biologic drugs has been a major theme in the global pharmaceutical industry
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forward
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
Biopharmaceuticals are medicinal drugs which are produced through biotechnology methods such as recombinant DNA techniques, fermentation, hybridoma techniques, and purification processes. Biopharmaceutical production involves the usage of biological sources, either live organisms or their active components. They are made up of proteins and nucleic acids and target specific diseases and patients groups. Biopharmaceuticals are used in the treatment of various chronic diseases such as cardiovascular, metabolic, neurological, cancer, and other rare diseases for which there are no available treatments.
New drug approvals & upcoming fda approvals 2021DoriaFang
In the first half of 2021, the U.S. FDA approved a total of 29 innovative drugs, of which 27 were new molecular entities and new biologics approved by the Center for Drug Evaluation and Research (CDER) and the remaining two were Car-T therapies (Abecma and Breyanzi) approved by the Center for Biologics Evaluation and Research (CBER).
Increasing Numbers of Launches and Growth in Spending on Specialty Products i...IMS Health US
The specialty products share of the R&D pipeline has increased 9% in the past decade, driven by drugs targeting cancer, nervous system disorders, infectious diseases, diabetes and respiratory disorders.
This document presents an analysis of the current state of the biosimilar market as well as its perspectives of evolution, with a particular focus on the French market
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
http://www.indxx.com/indices.php?id=211 - Thus far in the 21st century, the rise of biologic drugs has been a major theme in the global pharmaceutical industry
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
February 7, 2017
Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.
This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/looking-forward
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
Biopharmaceuticals are medicinal drugs which are produced through biotechnology methods such as recombinant DNA techniques, fermentation, hybridoma techniques, and purification processes. Biopharmaceutical production involves the usage of biological sources, either live organisms or their active components. They are made up of proteins and nucleic acids and target specific diseases and patients groups. Biopharmaceuticals are used in the treatment of various chronic diseases such as cardiovascular, metabolic, neurological, cancer, and other rare diseases for which there are no available treatments.
New drug approvals & upcoming fda approvals 2021DoriaFang
In the first half of 2021, the U.S. FDA approved a total of 29 innovative drugs, of which 27 were new molecular entities and new biologics approved by the Center for Drug Evaluation and Research (CDER) and the remaining two were Car-T therapies (Abecma and Breyanzi) approved by the Center for Biologics Evaluation and Research (CBER).
Increasing Numbers of Launches and Growth in Spending on Specialty Products i...IMS Health US
The specialty products share of the R&D pipeline has increased 9% in the past decade, driven by drugs targeting cancer, nervous system disorders, infectious diseases, diabetes and respiratory disorders.
This document presents an analysis of the current state of the biosimilar market as well as its perspectives of evolution, with a particular focus on the French market
Ομιλία - Παρουσίαση: “The Value of Innovation to Patients & Health Systems”
Clare Hague PhD, Therapy Area Market Access Leader for Hematology, Janssen EMEA Region
BIOSIMILARS - Regulation and Market Trends Joseph Pategou
Nowadays patients and physicians can have access to three types of drugs: a originators, a generic or a biosimilar.
Those drugs have different regulatory systems that apply in Europe; moreover the biosimilars regulation is evolving and may change. Regulation is an important factor that can give more confidence to patients and healthcare professionals. As a consequence, biosimilaires will grow.
Antimicrobial Resistance: A One Health Challenge for Joint ActionSIANI
Presented by Juan Lubroth at the seminar "Antimicrobial resistance; linkages between humans, livestock and water in peri-urban areas" at the World Water Week, 29th August 2016.
Low use of antimicrobials and healthy productive animals – a possible equation?SIANI
Presentation by Professor Ulf Magnusson, Swedish University of Agricultural Sciences/ SLU Global at the event: Low use of antimicrobials and healthy productive animals – a possible equation? At FAO Headquarters in Rome, Italy 19th of October, 2016.
The role of health technology assessment bodies in the value of cancer care i...Francois MAIGNEN
This presentation details the role of European HTA bodies in the value of new cancer therapies in Europe. The presentation also describes the NICE scientific advice activities and the activities of the HTA / regulatory parallel advice.
The data and analytics of the new life sciences marketplace handoutFrank Wartenberg
Trends in the global healthcare market. Development of pharmaceuticals, market data and insights.
Presentation delivered at the 9th International Pharmaceutical Compliance Congress and Best Practices Forum, Brussels, 2015
The way we bring new medicines to life is changing. Regulators, scientists and healthcare professionals are working together to ensure access to new medicines and other therapies is accelerated.
Similar to The Biosimilar Market Leader’s Perspective (20)
GoPharma is a telepharmacy mobile application that links pharmacists in Ghana to facilities that dispense medicine to patients. The idea comes from pharmacist Elvin Blankson, who wants to optimize services and cover regions where there are too few pharmacists.
Mohamed Shuraih and Yameen Rasheed are from the Maldives and submitted their idea, Blood Drive, to the Sandoz HACk competition. They were one of six finalists selected out of 150 ideas to present to a panel of judges at WIRED Health 2017 in London. These images show part of their journey over the three days that led to winning 20,000 Euros to help fund the implementation of their winning idea as well as Sandoz expert support to bring their idea to life.
The Maldives has the highest prevalence of Thalassemia in the world: this disease affects almost 1/5 Maldivians, according to Mohamed's research. One out of every 120 newborn is born with Thalassemia, and Without regular blood transfusions, 85 percent of these children will die by the age of five, he explains. Put simply, the demand for blood donors is greater than the number of people willing to give blood.
Blood Drive is a blood-donation app that connects blood donors in the Maldives. Through social media, and an innovative rewards system, it incentivizes people to give blood. With his Sandoz HACk idea, Mohamed hopes to ease the burden of Thalassemia in his country.
MedMee aims to support people in Pakistan, and around the world, in taking their medications properly and avoiding medication errors. It puts digital medical records in the hands of patients, and a virtual nurse named Casey offers advice on taking medicines. MedMee’s founders are Saif Ali, Abrar Ahmad and Badar Saeed.
On November 9, 2016, Sandoz held a #tweetchat focused on ways to increase access to medicines and the major challenges facing healthcare systems over the next 5-10 years.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
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Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
1. The Biosimilar Market Leader’s Perspective
Carol Lynch, Global Head of Sandoz Biopharmaceuticals
April 28, 2016
2. 2 | Medicines for Europe Biosimilars Conference | April 2016
10 years on, biosimilars have had a strong impact on
global healthcare
20+
Products approved by the
European Medicines Agency
over 10 years1
Product Approvals
551M€
Estimated cumulative
savings from biosimilars
epoetins in Germany
2007-20114
Healthcare system
savings
104%
Increase in standard units of
filgrastim in the UK from
2008-2014 (post biosimilar
launch)5
Increased patient
access
+50%
Market share for biosimilar
G-CSF2
Market Acceptance
+250m
Patient days of safe clinical
experience with Sandoz
biosimilars alone3
Patient Experience
1. European Medicines Agency Website
2. IMS MIDAS
3. Sandoz Product Safety Update Report (accessed October 2015)
4. IMS Institute for Healthcare Informatics: Assessing biosimilar uptake and competition in European markets. Date of Report: Oct 2014.
5. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar 2016.
3. 3 | Medicines for Europe Biosimilars Conference | April 2016
However, the status quo must change for biosimilars
to deliver on its promise
Strategic ImperativesCritical Challenges
Build Trust &
Confidence
Ensure Sustainable
Market Policies
Clarify Legal and
Regulatory Uncertainties
1. Stakeholder understanding
and acceptance
2. Disproportionate focus on
acquisition costs
3. Continued legal and regulatory
uncertainties (mainly in US)
4. 4 | Medicines for Europe Biosimilars Conference | April 2016
Recent US and EU biosimilar launches indicate
progress in building stakeholder acceptance.....
Physicians accept
biosimilar concept –
in acute care
settings
Economic value
recognized by payors
& healthcare providers
Pre-launch educational
efforts across
stakeholders helped
address key concerns
Source: IMS Pharmascope
1 Community medical center: MVZ in Germany, therefore, possible multiple specialties are included
0
5
10
15
20
25
21%
17%
Jan-15
5%
1%
6%
4%
15%
3%
Jun-15
1%
12%
1%
0%
11%
12%
2%
Apr-15
9%
Feb-15 MAR/15
6%
12%
4%
MAY/15
6%
0%
1%
0%
17%
4%
Others
Derma
GPs/community medical centers
Rheuma
Total Biosimilar penetration
Gastro
Filgrastim US Infliximab EU5
Prescriptions(in%)
5. 5 | Medicines for Europe Biosimilars Conference | April 2016
....However, all stakeholders must contribute to
improving trust and confidence in biosimilars
Payors: Support biosimilar
education amongst HCPs
Patient Groups: Develop
and share educational
content for patients
HCPs: Deepen
understanding of
biosimilars and help
reassure patients
Manufacturers: Ensure
availability of science-based
information on biosimilars
Govt: Continue to
highlight societal value of
biosimilars across
stakeholders
Regulators: Engage with
HCPs on robustness of
regulations/extrapolation
Increasing
adoption of
biosimilars
Collectively address the scourge of misinformation
6. 6 | Medicines for Europe Biosimilars Conference | April 2016
Considerable variation across the EU exists in terms of
payer policy approaches to biosimilars
Many patients
available for
manufacturers
to compete for
Most patients
out of reach for
manufacturers
National management passive (i.e.
fixed biosimilar price reduction)
No prescribing incentives
No prescription quota
Increased active management
nationally
Education of physicians by payers
Biosimilar prescribing stimulated
(quotas)
Competition averse Foster competition
Source: Adapted from IMS Health, IMS Consulting Group, March 2016
7. 7 | Medicines for Europe Biosimilars Conference | April 2016
Healthcare systems must advance policies that
ensure sustainability
Sustainable
Procurement
No “winner takes all
tenders”
Acknowledge that
biosimilars are not
generics: no
mandatory price cuts
Promote fair
competition and level-
playing field
Prescribing Incentives
“Gain-sharing” that
helps hospitals to
benefit from savings
Quotas to create
competition while
retaining prescriber
choice
Support acquisition of
most cost-effective
medication by
hospitals
8. 8 | Medicines for Europe Biosimilars Conference | April 2016
Legal and regulatory clarity essential for further
development of the biosimilars industry
Maintain established
regulatory
framework
BPCIA Ambiguities
INN & Labeling
Interchangeability
9. 9 | Medicines for Europe Biosimilars Conference | April 2016
Collectively, we can ensure biosimilars play an even
more transformational role in global healthcare
49-98B€
Expected cumulative savings from
biosimilars 2016-2020 in US+EU51
Generate savings for
healthcare systems
~5%
Patients with moderate-to-severe
psoriasis receiving biologic
medicines2
Improve patient access
1. IMS Institute for Healthcare Informatics: Delivering on the Potential of Biosimilar Medicines. Date of Report: Mar 2016.
2. Ref: Nast A, et al. Arch Dermatol Res 2013;305(10):899–907