IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
This document discusses regulatory and clinical perspectives on the interchangeability of biologicals and biosimilars. It notes that while generics are considered to be therapeutically equivalent, biosimilars are similar but not identical to the reference product. Regulators do not generally determine a biosimilar to be interchangeable without additional clinical evidence from switching studies demonstrating equivalent safety and efficacy when switching between the biosimilar and reference product. The clinical considerations around switching studies and their design are complex given the nature of biological products.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines.
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
This document is comprised of copyright notices from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) spanning the years 2014 through 2018, suggesting it contains content owned by IFPMA over those years. No other substantive information is provided in the document.
The document provides an overview of the International Psoriasis Council (IPC) and their partnership with ILDS and IFPA to execute the Global Psoriasis Atlas project. The IPC is a nonprofit organization comprised of the world's leading experts in psoriasis. They aim to advance knowledge of psoriasis and enhance patient care through research, education, and clinical practice guidelines. The document notes that worldwide prevalence and incidence of psoriasis is poorly understood currently. The Global Psoriasis Atlas project aims to address this through collecting epidemiological data on psoriasis prevalence, burden, and natural history across countries to inform policy and improve care.
This document discusses regulatory and clinical perspectives on the interchangeability of biologicals and biosimilars. It notes that while generics are considered to be therapeutically equivalent, biosimilars are similar but not identical to the reference product. Regulators do not generally determine a biosimilar to be interchangeable without additional clinical evidence from switching studies demonstrating equivalent safety and efficacy when switching between the biosimilar and reference product. The clinical considerations around switching studies and their design are complex given the nature of biological products.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines.
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
This document is comprised of copyright notices from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) spanning the years 2014 through 2018, suggesting it contains content owned by IFPMA over those years. No other substantive information is provided in the document.
The document provides an overview of the International Psoriasis Council (IPC) and their partnership with ILDS and IFPA to execute the Global Psoriasis Atlas project. The IPC is a nonprofit organization comprised of the world's leading experts in psoriasis. They aim to advance knowledge of psoriasis and enhance patient care through research, education, and clinical practice guidelines. The document notes that worldwide prevalence and incidence of psoriasis is poorly understood currently. The Global Psoriasis Atlas project aims to address this through collecting epidemiological data on psoriasis prevalence, burden, and natural history across countries to inform policy and improve care.
David K. Robinson, Ph. D.Vice President, BiologicsHead and Executive Director, Biologics and Vaccines CMC RegulatoryMerck & Co, Inc.
Presenting on behalf of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)WCBP CASS, Washington DC, USAJanuary 2014
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Professor Mahira Hamdy El Sayed
Dermatology and Venereology, Ain Shams University
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The document discusses psoriasis, a chronic skin condition affecting over 125 million people worldwide. Psoriasis causes thickened, red, scaly skin patches that often itch and bleed. It can also cause joint pain and increase risks for other health issues. The document outlines pharmaceutical company efforts to develop new drug treatments for psoriasis, including topical treatments, biologics, and oral medications currently in clinical trials. It emphasizes the need for comprehensive care that coordinates treatment from specialists and considers patients' needs to best manage psoriasis as a chronic condition.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Maurice Mayrides discusses the importance of the patient voice in regulating biosimilars. He summarizes the value of biosimilars from different stakeholder perspectives including patients, clinicians, industry, and governments. While biosimilars offer potential cost savings and innovation, patients will only feel comfortable with interchangeability if regulations are sophisticated and harmonized internationally. Regulations must ensure safety, efficacy, and quality to gain patient trust especially in emerging markets and lower-resource countries. Continued advocacy is needed to refine regulations and gather real-world evidence to demonstrate biosimilar interchangeability. The ultimate goal is ensuring patients can access effective treatments.
Este documento presenta información sobre biotecnológicos y biosimilares. Explica que los biosimilares no son genéricos ni copias idénticas de los biológicos originales debido a la complejidad de estas moléculas. Los biosimilares deben someterse a pruebas clínicas rigurosas para demostrar su eficacia y seguridad antes de su aprobación. La farmacovigilancia continua es fundamental para monitorear cualquier efecto adverso potencial de los biosimilares.
Biosimilars are complex biologic drugs that are similar but not identical to innovative biologic reference products. Several key points are made:
- Biosimilars are regulated differently than small molecule generics due to biologics' larger size and more complex manufacturing processes.
- While some regulators may designate a biosimilar as interchangeable, decisions on substitution are made separately at a national or state level.
- Health Canada does not declare any drug interchangeable and leaves substitution decisions to provinces, whereas the FDA may designate a biosimilar interchangeable if it is biosimilar and switching poses no greater risk to patients.
- Automatic substitution is not recommended and interchangeability requires specifically designed clinical trials for each
The document summarizes key points about the WHO International Nonproprietary Name (INN) Programme:
- The INN Programme assigns a single international nonproprietary name to pharmaceutical substances to ensure consistency worldwide and promote safe use of medicines globally.
- It aims to develop, establish, and promote international standards for naming pharmaceutical and biological products, including biotherapeutics.
- There is an ongoing discussion around developing a system for distinguishing biosimilar products through INN naming to promote unambiguous identification of reference products globally.
This document discusses the challenges of pharmacovigilance for biotherapeutic medicines. It notes that pharmacovigilance systems are developing at different rates globally, with inconsistent naming approaches for biotherapeutics. This can weaken signal detection. The document outlines five key challenges for biotherapeutics: 1) They are more complex and sensitive than small molecule drugs. 2) They can potentially elicit an immune response. 3) They can have complex pharmacology through multiple mechanisms. 4) Their properties are not fully predictable through preclinical studies. 5) They may follow different regulatory pathways than originator biologics like biosimilars. Comprehensive pharmacovigilance is needed due to potential safety differences between
The document discusses the work of the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre for International Drug Monitoring. The UMC collects and analyzes safety reports on medicines from around the world to identify potential safety issues and communicates these to improve patient safety. It maintains the VigiBase database and WHO drug dictionaries to support pharmacovigilance. The presentation highlights UMC's role in monitoring biotherapeutics and biosimilars, including the number of reports received on various biologic medicines over time and by region. It also discusses challenges in analyzing reports that only include the active substance versus those that specify the trade name or reference product.
This presentation provides an overview of the regulation of biotherapeutic medicines in Brazil. It discusses the development of regulations from 1976 to the current 2010 regulation, which takes specific approaches for biosimilars. The presentation outlines the pathways for approval, including an individual development pathway requiring full clinical data and a comparability pathway allowing reduced data if comparability to an existing product is shown. It provides details on non-clinical and clinical report requirements and considerations for both pathways. Finally, it discusses guidelines, partnerships and future perspectives on biological product regulation in Brazil.
David K. Robinson, Ph. D.Vice President, BiologicsHead and Executive Director, Biologics and Vaccines CMC RegulatoryMerck & Co, Inc.
Presenting on behalf of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)WCBP CASS, Washington DC, USAJanuary 2014
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Professor Mahira Hamdy El Sayed
Dermatology and Venereology, Ain Shams University
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The document discusses psoriasis, a chronic skin condition affecting over 125 million people worldwide. Psoriasis causes thickened, red, scaly skin patches that often itch and bleed. It can also cause joint pain and increase risks for other health issues. The document outlines pharmaceutical company efforts to develop new drug treatments for psoriasis, including topical treatments, biologics, and oral medications currently in clinical trials. It emphasizes the need for comprehensive care that coordinates treatment from specialists and considers patients' needs to best manage psoriasis as a chronic condition.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Maurice Mayrides discusses the importance of the patient voice in regulating biosimilars. He summarizes the value of biosimilars from different stakeholder perspectives including patients, clinicians, industry, and governments. While biosimilars offer potential cost savings and innovation, patients will only feel comfortable with interchangeability if regulations are sophisticated and harmonized internationally. Regulations must ensure safety, efficacy, and quality to gain patient trust especially in emerging markets and lower-resource countries. Continued advocacy is needed to refine regulations and gather real-world evidence to demonstrate biosimilar interchangeability. The ultimate goal is ensuring patients can access effective treatments.
Este documento presenta información sobre biotecnológicos y biosimilares. Explica que los biosimilares no son genéricos ni copias idénticas de los biológicos originales debido a la complejidad de estas moléculas. Los biosimilares deben someterse a pruebas clínicas rigurosas para demostrar su eficacia y seguridad antes de su aprobación. La farmacovigilancia continua es fundamental para monitorear cualquier efecto adverso potencial de los biosimilares.
Biosimilars are complex biologic drugs that are similar but not identical to innovative biologic reference products. Several key points are made:
- Biosimilars are regulated differently than small molecule generics due to biologics' larger size and more complex manufacturing processes.
- While some regulators may designate a biosimilar as interchangeable, decisions on substitution are made separately at a national or state level.
- Health Canada does not declare any drug interchangeable and leaves substitution decisions to provinces, whereas the FDA may designate a biosimilar interchangeable if it is biosimilar and switching poses no greater risk to patients.
- Automatic substitution is not recommended and interchangeability requires specifically designed clinical trials for each
The document summarizes key points about the WHO International Nonproprietary Name (INN) Programme:
- The INN Programme assigns a single international nonproprietary name to pharmaceutical substances to ensure consistency worldwide and promote safe use of medicines globally.
- It aims to develop, establish, and promote international standards for naming pharmaceutical and biological products, including biotherapeutics.
- There is an ongoing discussion around developing a system for distinguishing biosimilar products through INN naming to promote unambiguous identification of reference products globally.
This document discusses the challenges of pharmacovigilance for biotherapeutic medicines. It notes that pharmacovigilance systems are developing at different rates globally, with inconsistent naming approaches for biotherapeutics. This can weaken signal detection. The document outlines five key challenges for biotherapeutics: 1) They are more complex and sensitive than small molecule drugs. 2) They can potentially elicit an immune response. 3) They can have complex pharmacology through multiple mechanisms. 4) Their properties are not fully predictable through preclinical studies. 5) They may follow different regulatory pathways than originator biologics like biosimilars. Comprehensive pharmacovigilance is needed due to potential safety differences between
The document discusses the work of the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre for International Drug Monitoring. The UMC collects and analyzes safety reports on medicines from around the world to identify potential safety issues and communicates these to improve patient safety. It maintains the VigiBase database and WHO drug dictionaries to support pharmacovigilance. The presentation highlights UMC's role in monitoring biotherapeutics and biosimilars, including the number of reports received on various biologic medicines over time and by region. It also discusses challenges in analyzing reports that only include the active substance versus those that specify the trade name or reference product.
This presentation provides an overview of the regulation of biotherapeutic medicines in Brazil. It discusses the development of regulations from 1976 to the current 2010 regulation, which takes specific approaches for biosimilars. The presentation outlines the pathways for approval, including an individual development pathway requiring full clinical data and a comparability pathway allowing reduced data if comparability to an existing product is shown. It provides details on non-clinical and clinical report requirements and considerations for both pathways. Finally, it discusses guidelines, partnerships and future perspectives on biological product regulation in Brazil.
This document provides an overview of biosimilars and their development process according to international guidance. It begins with definitions of biosimilars and their differences compared to generic small molecule drugs. It then describes the two key steps in biosimilar development: 1) Developing a highly similar product through extensive analytical comparison to the reference product, and 2) Confirming biosimilarity through a targeted clinical program. It reviews guidelines from the WHO, EMA, and FDA on evaluating biosimilarity and the need for analytical, nonclinical and clinical comparisons. The document aims to explain the rigorous process of demonstrating biosimilarity that biosimilar developers must undergo to obtain regulatory approval.
The document discusses the importance of selecting sensitive patient populations for clinical trials of biosimilar monoclonal antibodies to properly assess clinical similarity to the reference product. It provides examples of indications and populations that are more sensitive for detecting differences based on effect size, such as rheumatoid arthritis patients for assessing ACR20 response to anti-TNF antibodies. The document cautions that clinical trials must be designed appropriately to demonstrate equivalence or non-inferiority and should obtain data on relevant endpoints in sensitive populations as well as long-term safety and immunogenicity follow-up to justify extrapolation to other indications. It critiques examples of biosimilar clinical trials that failed to use a sensitive population or design.
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