Hope S. Rugo, MD, FASCO, prepared useful Practice Aids pertaining to biosimilars for this CME/MOC/CNE/CPE activity titled "Biosimilars as Partners in Oncology: Expert Guidance on Understanding and Incorporating Biosimilar Agents in Real-World Care." For the full presentation, monograph, complete CME/MOC/CNE/CPE information, and to apply for credit, please visit us at http://bit.ly/38DBgFb. CME/MOC/CNE/CPE credit will be available until April 27, 2021.
Hope S. Rugo, MD, FASCO, prepared useful Practice Aids pertaining to biosimilars for this CME/MOC/CNE/CPE activity titled "Biosimilars as Partners in Oncology: Expert Guidance on Understanding and Incorporating Biosimilar Agents in Real-World Care." For the full presentation, monograph, complete CME/MOC/CNE/CPE information, and to apply for credit, please visit us at http://bit.ly/38DBgFb. CME/MOC/CNE/CPE credit will be available until April 27, 2021.
Aula preparada por Dra. Ana Cristina Martins (Especialista em regulação em saúde suplementar - ANS), Dra. Fabíola Giodani (Docente – UFF), Dra. Lusiele Guaraldo (Pesquisadora do Instituto Nacional de Infectologia Evandro Chagas/Fiocruz (Fiocruz).
Um Evento Adverso a Medicamento é qualquer dano causado pelo uso de um ou mais medicamentos com finalidade terapêutica, abrangendo, portanto, reações adversas aos medicamentos e erros de medicação.
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF, insulin, somatropin
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
Aula preparada por Dra. Ana Cristina Martins (Especialista em regulação em saúde suplementar - ANS), Dra. Fabíola Giodani (Docente – UFF), Dra. Lusiele Guaraldo (Pesquisadora do Instituto Nacional de Infectologia Evandro Chagas/Fiocruz (Fiocruz).
Um Evento Adverso a Medicamento é qualquer dano causado pelo uso de um ou mais medicamentos com finalidade terapêutica, abrangendo, portanto, reações adversas aos medicamentos e erros de medicação.
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF, insulin, somatropin
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
The insights driving superior healthcare outcomes in Asia Pacific.
Asia-Pacific Insight Magazine brings together IMS Health experts from across the region, delivering fresh perspectives on how to navigate through the challenges and opportunities in Asia-Pacific pharmaceutical market.
Future trends and perspectives in modern pharmaceutical biotechnologyinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Biosimilars are biological generics drugs.They undergo a rigorous evaluation to get approved.How to prove biosimilariy from analytical comparability is explained using a recently approved US FDA bio-similar monoclonal antibody.
This module is intended to introduce the students of biotechnology to obtain an overview of the pharmaceutical industry. The concept of clinical trials is discussed in brief.
At the 34th Spanish Health Economics Association annual meeting, Jorge Mestre-Ferrandiz reviewed the results of the discussions of an expert panel about the role of HTA for biosimilars. Representatives from the three UK HTA agencies, the MHRA, and academia discussed which HTA methods are most appropriate for biosimilars in specific situations.
The regulation of medicines in AustraliaTGA Australia
View this presentation for information on:
*the different categories of medicines
* registered (higher risk) medicines and how they are regulated
* listed (lower risk) medicines and how they are regulated
* accessing unauthorised medicines
* medicines advertising
* changing medicine technologies
The Role of Pharmacist in Patient SafetyArwa M. Amin
Module: Pharmacy Professional Skills
Coordinator: Dr. Arwa M. Amin Mostafa
Academic Level: Undergraduate, B.Pharmacy
School: Dubai Pharmacy College
Year of first presented in Class: 2018
This presentation is for Educational purpose. It has no commercial value associated with it.
Essential drug concept and rational use of medicinesPravin Prasad
Many medical students are unheard of the Essential Medicine List. This has been mentioned in very small sections in various textbooks that are in use in Nepal. The discussion on this topic is a must among medical and nursing students, as well as anyone related to field of Medicine
Similar to Biologics & Biosimilars - Joan o'callaghan - April 5th 2016 (20)
Derick Mitchell_Biobanking from the patient perspective.pdfipposi
IPPOSI CEO Derick Mitchell presented the patient perspective on biobanking at the 2023 WECAN Academy for Cancer Patient Advocates on July 2nd, 2023 in Frankfurt, Germany.
Mental Health - Leading the data sharing charge with a rights-based approachipposi
Frankie Prendergast's (Digital Health Applications Programme Manager in St Patrick's Mental Health Services) presentation on health information at the 2023 IPPOSI Conference.
Muiris O'Connor, Assistant Secretary of the Department of Health, presented key government updates on health information at the 2023 IPPOSI Conference Building a Data Sharing Health Sector in Ireland.
Clinical Workflow for Capture of Patient Registry Dataipposi
Clare Harney, Managing Director of HD Health, gave a lightning presentation on managing data for patient registries at the 2023 IPPOSI Conference on Building a Data Sharing Health Sector in Ireland.
EU Clinical Trials Regulation - IPPOSI perspectiveipposi
IPPOSI CEO, Dr Derick Mitchell delivered a presentation on the EU Clinical Trials Regulation from the patients' perspective at the 20th International Conference on Pharmaceutical Medicine, Athens, Greece.
Patient Centricity in Value-based healthcare, Sept 2022ipposi
IPPOSI CEO Derick Mitchell delivered a presentation as part of the RCSI Value Based Healthcare Webinar on Patient Centricity on Sept 18th, 2022.
The Future of Value Based Healthcare in Ireland webinar series is run by The RCSI Healthcare Outcomes Research Centre, Janssen Sciences Ireland UC and Novartis Ireland.
2022 World Day Brain Event - IPPOSI Presentationipposi
Laura Kavanagh, Research and Advocacy Manager in IPPOSI, gave a presentation on World Brain Day 2022 at an event hosted by the Neurological Alliance of Ireland.
In October 2020, IPPOSI published a membership engagement survey on its draft 4-year strategy. This slide deck captures the summary results of the survey.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
4. What is a biological medicine?
• Biological medicines contains active
substances made by a biological process or
are derived from a biological source.
• Broad term and examples include
– Hormones (e.g. insulin)
– Enzymes (enzyme replacement therapy)
– Monoclonal antibodies (targeted treatment)
– Blood derived products (clotting factors)
– Animal derived products (e.g. heparin, vaccines)
405/04/2016
5. What is a biological medicine?
• Biological medicines provide effective
treatments for a wide variety of serious
conditions. Examples include
– Diabetes mellitus (Lantus®)
– Rheumatoid Arthritis (Humira®)
– Cancer (Herceptin®)
– Multiple Sclerosis (Tysabri®)
05/04/2016 5
6. What is a biological medicine?
• Most biological medicines are
produced from the cell cultures of
living organisms
• Often the cells have been engineered
in order to produce a therapeutic
molecule or group of molecules,
usually proteins
05/04/2016 6
7. Biological medicines have a complex
manufacturing process
05/04/2016 7
Source: Slide by Nanna Aaby Kruse, Mediacademy, Oct 2011
9. Biological Medicines and Chemical Medicines
Biological medicines Chemical Medicines
Large complex structure
Inherent natural variability
Synthesis in living organisms-
difficult to reproduce
No two batches likely to be
identical
More likely to cause an immune
reaction due to size and structure
Generally given by
injection/infusion
Generally prescribed by specialists
Small simple structure
Single well defined chemical
structure
Made by combining chemical
ingredients
Reproducible manufacturing
process
Unlikely to cause immune reaction
due to small size
Often taken orally
Prescribed by GPs and/or
specialists05/04/2016 9
11. Biological Medicines
• Biological medicines have revolutionised
the treatment of many diseases including
cancer, rheumatoid arthritis, psoriasis,
inflammatory bowel disease and diabetes
• Biological medicines are high cost and use
is often limited
• Patents of many ‘blockbuster’ biological
medicines have expired or are nearly
expired
05/04/2016 11
14. What is a biosimilar medicine?
A biosimilar is a biological medicine that is
highly similar to another biological medicine
(reference product) that has already been
approved for use in patients
A biosimilar is not a generic
05/04/2016 14
15. Biosimilars v’s Generics
• Generic medicines are
usually small molecule
‘chemical’ medicines
• A generic medicine is an
exact copy of a reference
medicine
• It is not possible to make an
exact copy of a biological
medicine
05/04/2016 15
16. Biosimilar medicines
• Only comes on market after
patent of reference product has
expired
• Encourages competition which
can lead to price reductions and
improve patient access to high
cost medicines
05/04/2016 16
“Similar but not
identical”
.
19. Biosimilar approval process
Manufacturers must demonstrate
to regulators that biosimilars have
similar quality, safety and efficacy
to the reference product and there
are no clinically meaningful
differences between the two
Tailored approach which involves a
comparability exercise against the
reference product
First step: quality comparability
Second step: pre-clinical
comparability
Third step: clinical comparability
05/04/2016 19
20. Quality comparability
• Quality testing is cornerstone of
biosimilarity
• Large number of physiochemical
and biological tests
• Quality comparability exercise must
show biosimilar is highly similar to
reference
• Potential impact of any (minor)
quality differences on safety and
efficacy must be addressed
05/04/2016 20
Quality
Clinical
21. Pre-clinical comparability
Pre-clinical studies are required for all new
medicines. Involves testing in cell culture and
in animals in order to determine safety profile
prior to use in humans
For biosimilars preclinical studies relate to
mechanism of action of medicine and could
uncover subtle differences between reference
and biosimilar
Testing in animals may not always be
necessary
05/04/2016 21
22. Clinical comparability
Clinical trials are designed to see if
clinically meaningful differences exist
between reference and biosimilar
Generally includes data on
pharamacokinetics,
pharmacodynamics, safety and
efficacy
Testing for immunogenicity required
05/04/2016 22
23. Indication extrapolation
• Clinical data may not be
required for the biosimilar
in all indications
• Must be scientifically
justified
• Similar approach is used to
justify post-approval
changes for other
biological medicines
• Approved on case by case
basis
05/04/2016 23
25. Pharmacovigilance
Science of monitoring, evaluating and
preventing drug-related adverse events
Clinical safety of all biologicals must be
monitored on an on-going basis after
approval
New medicines including biosimilars are
subject to additional monitoring for a
certain time period after authorisation
Patients should report side effects to the
HPRA and/or their healthcare
professional
05/04/2016 25
26. Traceability of biological medicines
05/04/2016 26
Biological medicines exhibit
variability: therefore biological
medicines with the same
international non-proprietary
name (INN) should not be
considered identical
Prescribe, dispense
and record using
brand name
Changes in manufacturing
processes can affect
likelihood of medicine
causing an immune
reaction
Adverse reaction reports
should include brand name
and batch number
28. Information for patients
European Medicines Agency website: ‘Find
Medicine’ section
• Summary of assessment available
• Further information: Package leaflet etc.
05/04/2016 28
29. HPRA Guideline on biosimilars
• Regulation
• Product information
• Prescribing
• Dispensing
• Traceability
05/04/2016 29
31. 3105/04/2016
Interchangeability, substitution and
switching
Interchangeability: medical practice of
changing one medicine for another
that is expected to achieve the same
clinical effect in a given clinical setting
and in any patient (prescriber is
involved)
Substitution : practice of dispensing
one medicine instead of another
equivalent and interchangeable
medicine at the pharmacy level without
consulting the prescriber
Switching: decision from treating
physician to exchange one medicine
for another medicine with the same
therapeutic intent in patients who are
undergoing treatment.
32. Substitution in Ireland
• ‘Generic substitution’ allows for
most chemical medicines to be
substituted for each other at the
pharmacy level
• Biological medicines are excluded
from ‘generic substitution’
• Pharmacists cannot ‘substitute’ a
reference medicine for a
biosimilar or vice versa unless
there is prescriber agreement
05/04/2016 32
33. HPRA position on interchangeability and
switching
05/04/2016 33
If it is planned to change the
medicine a patient receives from a
reference to a biosimilar medicine
or vice versa, the treating physician
should be involved; this should
involve discussion between the
prescriber/patient and
prescriber/dispensing pharmacist
• Ongoing engagement between prescribers, dispensers
and those with responsibility for procurement
• Stakeholder engagement to ensure optimal use of
resources and ensure the best patient outcomes
• Switching back and forth not recommended as
currently availability of data on the impact of this is
limited
34. International policies
• Tendering process determines which brand of biological
medicine is used in hospitals
• High uptake of infliximab biosimilar (new patients and
switching)
Denmark
• Pharmacist substitution possible if brand is given an ‘a’ flag
following evaluation by the reimbursement body
• Prescriber and patients retain right to decline substitution
Australia
• Category for ‘interchangeable biological product’ (no
medicine approved in this category to date)
• Legislation to allow pharmacist substitution of
‘interchangeable biological products’ passed in 16 states
United
States
05/04/2016 34
37. RSI: Biosimilar Project
• Research activities: HPRA and UCC
• Supported by: HPRA, UCC and IPHA
• Industry Advisors: Merck, AbbVie, Novartis
• Objectives
• Peer reviewed scientific publications (practical
considerations for healthcare professionals)
• Survey perspectives and understanding of
biosimilars
• Comparative studies of international models for
providing safe and effective use of biosimilars
• Develop training materials and online resources
• Outreach activities
05/04/2016 37
38. RSI Biosimilar Project
Publications to date
• Biosimilar Medicines: Opportunities and
Challenges in the clinical use and supply of
Biosimilars (IPN and HPN)
• Biosimilar Medicines: Recent Developments
(HPN)
Prescriber survey
• Knowledge, behaviours and attitudes towards
biological medicines specifically biosimilars
05/04/2016 38