This document outlines the objectives of the Centro Latino Americano de Pesquisa em Biológicos (CLAPBio). CLAPBio aims to strengthen regulatory and economic decision making regarding biosimilars in Latin America through three main objectives: 1) Developing tools and training national teams, 2) Creating an economic model for biosimilars, and 3) Establishing collaborations across organizations in Latin American countries. Key activities include creating guidelines, conducting studies, providing technical support, and launching an online learning platform to disseminate information on biosimilars. The overall goal is to support informed and evidence-based decisions regarding biosimilar approval and adoption in the region.
Innovating in the life sciences and health-care sector? You can’t escape the regulators! Before you make a costly mistake, learn from the experts who have been through the process before.
Whether you’re working on a therapeutic, an in vitro diagnostic or a medical device, come find out how to identify and mitigate challenges along the path to regulatory approval.
Where are you in your drug development journey? Find out how to expedite your drug development program. View our drug development journey map. Download the document to zoom in and view details.
Guide for conducting comparability exercise for biological product registrationClapbio
This document provides guidance for conducting a comparability exercise between a proposed biological product (BP) and an authorized comparator biological product (CBP) for the purpose of biological product registration. It outlines the quality, stability, manufacturing process, and data requirements that must be evaluated and presented in a comparability study to demonstrate that the BP is similar to the CBP, upon which reduced nonclinical and clinical data can be relied. Key aspects that must be compared include quality attributes, samples from manufacturing process stages, stability under stress conditions, and data from multiple batches. Significant unjustified differences found would indicate the products are not similar.
The document discusses bioavailability and bioequivalence of drug products. It defines bioavailability as the rate and extent of drug absorption and availability at the site of action. Bioequivalence means that two drug products have equivalent rates and extents of absorption, as measured by peak concentration and total exposure in the body. The document outlines factors that can affect bioavailability and discusses the importance of demonstrating bioequivalence through clinical studies for generic drug approval.
This document discusses the regulatory requirements for clinical development of biosimilars in India. It provides an overview of the applicable regulations, guidelines, and authorities overseeing clinical trials. The key principles for developing biosimilars are to demonstrate comparability to the reference biologic through a stepwise characterization and clinical development program involving pharmacokinetic, pharmacodynamic, and confirmatory safety and efficacy studies. Post-marketing requirements include pharmacovigilance plans and potential post-marketing studies to further evaluate safety and immunogenicity.
Innovating in the life sciences and health-care sector? You can’t escape the regulators! Before you make a costly mistake, learn from the experts who have been through the process before.
Whether you’re working on a therapeutic, an in vitro diagnostic or a medical device, come find out how to identify and mitigate challenges along the path to regulatory approval.
This document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of non-clinical laboratory studies. It was created by the FDA in 1978 after investigations found fraudulent activities and poor practices in toxicology labs. GLP provides principles for planning, conducting, monitoring, recording, reporting and archiving laboratory studies according to standard operating procedures to ensure the quality and integrity of data. Non-compliance with GLP can result in the disqualification of a testing facility, rejection of study data, and civil or criminal penalties.
Innovating in the life sciences and health-care sector? You can’t escape the regulators! Before you make a costly mistake, learn from the experts who have been through the process before.
Whether you’re working on a therapeutic, an in vitro diagnostic or a medical device, come find out how to identify and mitigate challenges along the path to regulatory approval.
Where are you in your drug development journey? Find out how to expedite your drug development program. View our drug development journey map. Download the document to zoom in and view details.
Guide for conducting comparability exercise for biological product registrationClapbio
This document provides guidance for conducting a comparability exercise between a proposed biological product (BP) and an authorized comparator biological product (CBP) for the purpose of biological product registration. It outlines the quality, stability, manufacturing process, and data requirements that must be evaluated and presented in a comparability study to demonstrate that the BP is similar to the CBP, upon which reduced nonclinical and clinical data can be relied. Key aspects that must be compared include quality attributes, samples from manufacturing process stages, stability under stress conditions, and data from multiple batches. Significant unjustified differences found would indicate the products are not similar.
The document discusses bioavailability and bioequivalence of drug products. It defines bioavailability as the rate and extent of drug absorption and availability at the site of action. Bioequivalence means that two drug products have equivalent rates and extents of absorption, as measured by peak concentration and total exposure in the body. The document outlines factors that can affect bioavailability and discusses the importance of demonstrating bioequivalence through clinical studies for generic drug approval.
This document discusses the regulatory requirements for clinical development of biosimilars in India. It provides an overview of the applicable regulations, guidelines, and authorities overseeing clinical trials. The key principles for developing biosimilars are to demonstrate comparability to the reference biologic through a stepwise characterization and clinical development program involving pharmacokinetic, pharmacodynamic, and confirmatory safety and efficacy studies. Post-marketing requirements include pharmacovigilance plans and potential post-marketing studies to further evaluate safety and immunogenicity.
Innovating in the life sciences and health-care sector? You can’t escape the regulators! Before you make a costly mistake, learn from the experts who have been through the process before.
Whether you’re working on a therapeutic, an in vitro diagnostic or a medical device, come find out how to identify and mitigate challenges along the path to regulatory approval.
This document discusses Good Laboratory Practice (GLP), which are quality standards that regulate the conduct of non-clinical laboratory studies. It was created by the FDA in 1978 after investigations found fraudulent activities and poor practices in toxicology labs. GLP provides principles for planning, conducting, monitoring, recording, reporting and archiving laboratory studies according to standard operating procedures to ensure the quality and integrity of data. Non-compliance with GLP can result in the disqualification of a testing facility, rejection of study data, and civil or criminal penalties.
Anthony Presentation at DIA Chicago Oct 2008AKTaylor
The requirements of the clinical trial databases provision in the FDA
Amendments Act apply to academic and independent investigators
as well as to industry conducted clinical trials. This session will
highlight the challenges faced by academic and independent investigators
and best practices in registering clinical trials and establishing
procedures for reporting study results to ClinicalTrials.gov.
Lecture given to Unit 8 (INDS 208) -- Pathobiology Treatment and Prevention of Disease -- in the undergraduate medical curriculum at McGill University on September 10, 2012.
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
The document discusses searching the pharmacology literature. It outlines the five phases of the drug life cycle: drug discovery, pre-clinical research, clinical trials, review, and ongoing analysis. It provides examples of databases to search within each phase, such as PubMed, Embase, and ClinicalTrials.gov. Advanced search techniques are covered, including using subject headings, Boolean operators, and filters. It also reviews citation management software like RefWorks.
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
This document provides information about an upcoming webinar on drug types including biosimilars and generics. It outlines details like the speaker, how to ask questions during the webinar, and instructions for accessing the webinar archive and following along on Twitter. It also provides brief bios of the speaker and gives technical instructions for participating in the webinar platform. Finally, it lists some resources and includes a standard disclaimer.
The development & approval of Novoeight, a case studyAllen Che
The FDA approved Novoeight, a recombinant Factor VIII treatment for hemophilia A, in October 2013 based on positive results from clinical trials. Novoeight was found to effectively control and prevent bleeding episodes in adults and children with hemophilia A. The approval process involved reviewing manufacturing, clinical data, and inspections to ensure safety and efficacy. This approval expands treatment options for hemophilia A patients and represents continued innovation in the development of safer recombinant clotting factor therapies.
This 3-day event is the meeting place for international and domestic scientists to share case studies and project updates, showcase new techniques and form collaborations that pave the way towards the future of China’s biopharmaceutical industry.
This document provides information about Good Laboratory Practices (GLP). It begins by defining GLP as an FDA regulation that establishes principles for conducting laboratory studies. It then discusses the history of GLP, including how it was created by the FDA in 1978 in response to discovering fraudulent activities and poor practices at laboratories. The objectives and mission of GLP are to ensure data submitted are accurate reflections of study results and promote international acceptance of tests. Key aspects of GLP compliance discussed include standard operating procedures, instrumentation and reagent validation, analyst and laboratory certification, and specimen tracking.
This document provides information about Good Laboratory Practices (GLP). It begins by defining GLP as an FDA regulation that establishes principles for conducting laboratory studies. The history section describes how GLP was created by the FDA in 1978 in response to discovering fraudulent activities and poor practices at laboratories. A famous example discussed was a lab that covered up cancer in mice during product testing. The objectives, mission, and standard operating procedures of GLP are described to ensure accurate, traceable data and international acceptance of tests. Instrument validation, reagent certification, analyst certification, and specimen tracking are discussed as important aspects of GLP.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
The document discusses the drug discovery and development process. It begins by outlining the key steps from lead identification to establishing proof of concept, including medicinal chemistry, biological screening, and ADME-PK analysis. It then provides an overview of the drug development phases, noting they can take 10 years on average and involve screening thousands of compounds. The document details each phase of clinical trials and highlights the low success rates. It concludes by defining some key terms in the drug discovery process and noting the reality that the majority of programs fail due to lack of efficacy, toxicity, or pharmacokinetic issues.
This document provides an overview of biosimilars. It defines biosimilars as subsequent versions of biologic medicines where patent protection has expired. Biosimilars are approved based on similarity to an original reference biologic in terms of quality, safety and efficacy, but are not expected to be identical due to structural complexities. The development of biosimilars involves extensive comparative studies to the reference product. Concerns with biosimilars include potential immunogenicity, efficacy issues, and uncertainty around switching between originator and biosimilar products or between biosimilars. Proper pharmacovigilance is important to monitor biosimilar safety and benefits.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Bruce Patsner is an Oncologist and has served as Director of North American Operations for Legacy Healthcare since 2017; he is based in Boston, Massachusetts.
The document describes a test system for rapid diagnosis of pregnancy in livestock. The system allows diagnosis through a liquid or test strip using urine samples and can detect pregnancy from 2 weeks onwards without specialized equipment. It provides reliable results (99.2-99.5% accuracy) within 30 minutes. Compared to existing methods like rectal exams or laboratory tests, the system requires no veterinarian, costs less at 2-3.5 euros per test, and poses no infection risk. Market analysis shows strong domestic and export demand that could reach 6,500 and 3,600 units annually by 2016. The producer is seeking cooperation on sales, production and financing to develop the innovative technology.
Lior - Improving Medication Safety in RadiologyLior Molvin
This webinar explores medication safety issues in radiology settings. It will discuss cases where errors have occurred and risk reduction strategies. Nationally recognized experts will address topics like safe contrast use, proper labeling, expiration dating, and patient identification. Faculty will examine a new Imaging Bulk Package for contrast approved by the FDA and regulatory/Joint Commission requirements for contrast and medication use in radiology. The goal is for pharmacists and radiologic technologists to understand medication ordering, storage, preparation and use in radiology; differentiate new Imaging Bulk Packages from Pharmacy Bulk Packages; and identify system causes of radiology medication errors to prioritize prevention strategies.
This document discusses biosimilars and intended copies of biological drugs. It defines biosimilars as biological products that are highly similar to an original biologic and are approved through a rigorous regulatory process requiring demonstration of similarity. Intended copies are defined as biological products that claim similarity but did not undergo the same rigorous approval process. The document outlines key differences between biosimilars and intended copies, including higher heterogeneity and lack of established comparability for intended copies. It analyzes several intended copy products for etanercept and concludes they do not meet criteria for demonstrating comparability to the original product. The document emphasizes the importance of well-designed comparative clinical studies for determining similarity of intended copies to original biologics.
The document discusses the key differences between intended copies, biosimilars, and original biological products. Intended copies are biological products that show similarity to originals but did not undergo rigorous regulatory approval per WHO/EMA/FDA guidelines. Biosimilars demonstrate similarity to originals based on comprehensive analytical, nonclinical, and clinical studies. In contrast to biosimilars, intended copies have shown more heterogeneity, lack established comparability, and have limited clinical data published. The document concludes intended copies should not be considered interchangeable with original products due to lack of sufficient data on their efficacy and safety.
This document provides an overview of biosimilars and their regulatory framework. It begins with definitions of biologics and biosimilars. Biosimilars are highly similar versions of approved biologics whose patents have expired. The development of biosimilars is unique compared to small molecule generics due to the complex nature of biologics. The document then discusses issues with biosimilars including potential efficacy, safety and substitution concerns. Finally, it provides details on the regulatory frameworks and guidelines established by organizations like WHO, EU, US and India to help facilitate the development and approval of biosimilars.
Este documento discute as considerações regulatórias sobre produtos biológicos no Brasil. A Resolução RDC no 55 estabelece requisitos para o registro de produtos biológicos no país, incluindo duas vias regulatórias: uma via de desenvolvimento por comparabilidade e outra via de desenvolvimento individual. No entanto, a resolução não esclarece sobre a necessidade de estrutura molecular idêntica entre produtos biológicos similares e de referência, que é essencial segundo diretrizes da OMS para garantir qualidade,
Este documento discute las consideraciones regulatorias sobre productos biológicos en Brasil. Presenta datos sobre el gasto en salud en Brasil y la necesidad de mayor financiamiento público para cumplir con los estándares internacionales de acceso universal a la salud. También analiza la Resolución RDC No. 55 de 2010 de la agencia regulatoria brasileña ANVISA, la cual establece los requisitos para el registro de nuevos productos biológicos y productos biológicos similares. Finalmente, señala algunas preocupaciones con respecto
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Anthony Presentation at DIA Chicago Oct 2008AKTaylor
The requirements of the clinical trial databases provision in the FDA
Amendments Act apply to academic and independent investigators
as well as to industry conducted clinical trials. This session will
highlight the challenges faced by academic and independent investigators
and best practices in registering clinical trials and establishing
procedures for reporting study results to ClinicalTrials.gov.
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- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
The document discusses searching the pharmacology literature. It outlines the five phases of the drug life cycle: drug discovery, pre-clinical research, clinical trials, review, and ongoing analysis. It provides examples of databases to search within each phase, such as PubMed, Embase, and ClinicalTrials.gov. Advanced search techniques are covered, including using subject headings, Boolean operators, and filters. It also reviews citation management software like RefWorks.
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
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The development & approval of Novoeight, a case studyAllen Che
The FDA approved Novoeight, a recombinant Factor VIII treatment for hemophilia A, in October 2013 based on positive results from clinical trials. Novoeight was found to effectively control and prevent bleeding episodes in adults and children with hemophilia A. The approval process involved reviewing manufacturing, clinical data, and inspections to ensure safety and efficacy. This approval expands treatment options for hemophilia A patients and represents continued innovation in the development of safer recombinant clotting factor therapies.
This 3-day event is the meeting place for international and domestic scientists to share case studies and project updates, showcase new techniques and form collaborations that pave the way towards the future of China’s biopharmaceutical industry.
This document provides information about Good Laboratory Practices (GLP). It begins by defining GLP as an FDA regulation that establishes principles for conducting laboratory studies. It then discusses the history of GLP, including how it was created by the FDA in 1978 in response to discovering fraudulent activities and poor practices at laboratories. The objectives and mission of GLP are to ensure data submitted are accurate reflections of study results and promote international acceptance of tests. Key aspects of GLP compliance discussed include standard operating procedures, instrumentation and reagent validation, analyst and laboratory certification, and specimen tracking.
This document provides information about Good Laboratory Practices (GLP). It begins by defining GLP as an FDA regulation that establishes principles for conducting laboratory studies. The history section describes how GLP was created by the FDA in 1978 in response to discovering fraudulent activities and poor practices at laboratories. A famous example discussed was a lab that covered up cancer in mice during product testing. The objectives, mission, and standard operating procedures of GLP are described to ensure accurate, traceable data and international acceptance of tests. Instrument validation, reagent certification, analyst certification, and specimen tracking are discussed as important aspects of GLP.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
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This document provides an overview of biosimilars. It defines biosimilars as subsequent versions of biologic medicines where patent protection has expired. Biosimilars are approved based on similarity to an original reference biologic in terms of quality, safety and efficacy, but are not expected to be identical due to structural complexities. The development of biosimilars involves extensive comparative studies to the reference product. Concerns with biosimilars include potential immunogenicity, efficacy issues, and uncertainty around switching between originator and biosimilar products or between biosimilars. Proper pharmacovigilance is important to monitor biosimilar safety and benefits.
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This document discusses biosimilars and intended copies of biological drugs. It defines biosimilars as biological products that are highly similar to an original biologic and are approved through a rigorous regulatory process requiring demonstration of similarity. Intended copies are defined as biological products that claim similarity but did not undergo the same rigorous approval process. The document outlines key differences between biosimilars and intended copies, including higher heterogeneity and lack of established comparability for intended copies. It analyzes several intended copy products for etanercept and concludes they do not meet criteria for demonstrating comparability to the original product. The document emphasizes the importance of well-designed comparative clinical studies for determining similarity of intended copies to original biologics.
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Este documento discute as considerações regulatórias sobre produtos biológicos no Brasil. A Resolução RDC no 55 estabelece requisitos para o registro de produtos biológicos no país, incluindo duas vias regulatórias: uma via de desenvolvimento por comparabilidade e outra via de desenvolvimento individual. No entanto, a resolução não esclarece sobre a necessidade de estrutura molecular idêntica entre produtos biológicos similares e de referência, que é essencial segundo diretrizes da OMS para garantir qualidade,
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This document outlines regulations for controlling human pharmaceutical products in a national system. It establishes the Ministry of Health and the Institute of Public Health as the competent authorities responsible for regulating pharmaceutical activities including registration, manufacturing, distribution, and advertising. It also assigns responsibilities to Regional Health Departments for authorizing product admission and enforcing compliance. Finally, it provides definitions for 29 key terms related to pharmaceutical quality, safety, and regulation.
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Este documento fornece diretrizes para a elaboração de relatórios clínicos para fins de registro e alterações pós-registro de produtos biológicos. Ele abrange os seguintes tópicos: 1) introdução geral; 2) ética; 3) objetivos do estudo; 4) plano de investigação; 5) tratamentos; 6) randomização e mascaramento; 7) desfechos de eficácia e segurança; 8) métodos estatísticos; 9) sujeitos de pesquisa; 10) avaliação da eficácia;
Wayanad-The-Touristry-Heaven to the tour.pptxcosmo-soil
Wayanad, nestled in Kerala's Western Ghats, is a lush paradise renowned for its scenic landscapes, rich biodiversity, and cultural heritage. From trekking Chembra Peak to exploring ancient Edakkal Caves, Wayanad offers thrilling adventures and serene experiences. Its vibrant economy, driven by agriculture and tourism, highlights a harmonious blend of nature, tradition, and modernity.
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Denizar vianna clap_bio_meeting_rio_dec16th2011 [modo de compatibilidade]
1. Universidade do Estado do Rio de Janeiro
Universidade do Estado do Carneiro
Policlínica Piquet Rio de Janeiro
Departamento de Clínica Médica
Instituto de Ensino e Pesquisa
Centro Latino Americano de Pesquisa em Biológicos
Introduction of participants and
objectives of the meeting
Denizar Vianna
2. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Agenda
Instituto de Ensino e Pesquisa
Who are we?
Meeting objectives
3. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Agenda
Instituto de Ensino e Pesquisa
Who are we?
Meeting objectives
15. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Meeting objectives
Instituto de Ensino e Pesquisa
To discuss how to create a regional team, involving
collaborations across multiple organizations: regulatory
authorities, academic institutions, medical specialities
associations;
To present tools for provide training to national
multidisciplinary teams;
To discuss how to develop an Economic Model and
Shared Decision Making for BioSimilar in Latin America.
16. Universidade do Estado do Rio de Janeiro
Universidade do Estado do Carneiro
Policlínica Piquet Rio de Janeiro
Departamento de Clínica Médica
Instituto de Ensino e Pesquisa
Centro Latino Americano de Pesquisa em Biológicos
Overview of projects to be
conducted by CLAPBio
Denizar Vianna
17. Universidade do Estado do Rio de Janeiro
Universidade do Estado do Carneiro
Policlínica Piquet Rio de Janeiro
Departamento de Clínica Médica
Instituto de Ensino e Pesquisa
Centro Latino Americano de Pesquisa em Biológicos
Infrastructure for regulatory
authorities in LA Countries
Denizar Vianna
18. Universidade do Estado do Rio de Janeiro
REQUIREMENTS Policlínica Piquet Carneiro
WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
Instituto de Ensino e Pesquisa
The reference product must be licensed by the
national regulatory authority based on a full
no yes yes no yes no NA
development dossier (quality, safety, and efficacy
data)
A biosimilar/intended copy may be a reference
product in case the innovative product is not no no yes no no no no NA
available in the market
Full quality dossier (manufacturing process,
characterization, specifications, analytical
yes yes yes yes/no yes yes yes yes
techniques and stability) plus head-to-head
comparison with the reference product
Functional, physicochemical and biological head-to-
head characterization data in comparison with the yes yes yes yes/no yes yes yes
reference product
Identical primary amino acid sequence yes yes no yes no No
19. Universidade do Estado do Rio de Janeiro
REQUIREMENTS WHO EMA MEXICO BRAZIL CHILE PERU CUBA PANAMA
Policlínica Piquet Carneiro
Non-clinical requirements: Abbreviated head-to- de Ensino e Pesquisa
Instituto
head non-clinical pharmacology and toxicology yes yes yes yes/no yes yes yes
studies in comparison with the reference product
Clinical requirements: But with no specific
NA NA yes NA NA NA yes
requirements established
Clinical requirements: Abbreviated head-to-head
Pharmacokinetic (PK) and Pharmacodynamic (PD) yes yes no yes/no yes yes NA
studies in comparison with the reference product
Clinical requirements: Abbreviated head-to-head
It is not
efficacy studies in comparison with the reference yes yes no NA NA NA
clear yet
product: equivalence or non-inferiority clinical trials
Clinical requirements: Abbreviated head-to-head
efficacy studies in comparison with the reference It is not
NA NA no yes/no NA NA
product: equivalence, non-inferiority or superiority clear yet
clinical trials
20. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
REQUIREMENTS
Instituto de Ensino e MEXICO BRAZIL CHILE
WHO EMA
Pesquisa PERU CUBA PANAMA
Clinical requirements: Abbreviated head-to-head
safety studies including immunogenicity in yes yes yes no yes no no
comparison with the reference product
Product-class specific guidelines on non-
no yes no yes yes yes no
clinical/clinical data
Extrapolation across indications (if justified and
yes yes yes yes yes yes NA
specific criteria is satisfied)
Active pharmacovigilance plan and safety
specification (including submission of Periodic
yes yes yes yes yes yes yes yes
Safety Update Reports [PSURs] and Adverse Drug
Reaction [ADR] Reporting)
Risk Management Plan (RMP) yes yes no yes yes yes yes yes
21. Universidade do Estado do Rio de Janeiro
BRAZIL CHILE PERU CUBA PANAMA
REQUIREMENTS
PoliclínicaWHO EMACarneiro
Piquet MEXICO
Instituto de Ensino e Pesquisa
Prescription by non-proprietary name (INN), a
It is not
unique brand name and batch number for a yes yes no NA yes no
clear yet
traceability system
Automatic substitution (interchangeability) NA NA yes NA no NA no
Prescribing information (package insert) clearly
specifying the clinical safety and efficacy data
obtained by the biosimilar product itself from those
no no no no no no no
taken over from the reference product, particularly
in extrapolated indications where no studies have
been done at all
Special differentiated labelling (outer cartons and
no no yes no no no no
labels) between biosimilars and reference product
Intellectual property (Patents and/or Data
NA yes yes yes no no no
Protection)
Stand alone pathway accepted if intended copy is
not similar to the reference product (full licensing yes yes yes yes/no yes yes yes
application)
22. Universidade do Estado do Rio de Janeiro
Universidade do Estado do Carneiro
Policlínica Piquet Rio de Janeiro
Departamento de Clínica Médica
Instituto de Ensino e Pesquisa
Centro Latino Americano de Pesquisa em Biológicos
Budget Impact Analysis Tool
Denizar Vianna
24. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Agenda
Instituto de Ensino e Pesquisa
1. Estimating Savings from Biosimilars in Latin America
2. Health Economics
3. CLAPBio’s objectives
25. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Agenda
Instituto de Ensino e Pesquisa
1. Estimating Savings from Biosimilars in Latin America
2. Health Economics
3. CLAPBio’s objectives
26. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Instituto de Ensino e Pesquisa
“Experience with biosimilars is very limited, as is
reliable information about their impact on
pharmaceutical markets.
As a result, behaviour and expectations by all
stakeholders currently is based more on
assumption than on fact”.
Professor Bengt Jönsson
Source: Mattison et al. Biosimilars: How much entry and price competition will
result? December 2010. Office of Health Economics
27. Universidade do Estado do Rio de Janeiro
Examples of Impact Estimates
Policlínica Piquet Carneiro
Instituto de Ensino e Pesquisa
Source: Mattison et al. Biosimilars: How much entry and price competition will
result? December 2010. Office of Health Economics
28. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Agenda
Instituto de Ensino e Pesquisa
1. Estimating Savings from Biosimilars in Latin America
2. Health Economics
3. CLAPBio’s objectives
32. What is Economic Evaluation?
Definition: Economic Evaluation is ...
– the identification, measure, and comparison of
the costs (i.e. resources consumed) and
outcomes (clinical, economic) of interventions
(pharmaceuticals, diagnostics, public health
programs)
33. Cost Effectiveness Analysis (CEA)
Cost-effectiveness analysis (CEA) compares the cost of
the intervention with the effect, resulting in a cost per
effect (eg, cost per year of life gained) that can be
compared across interventions.
In CEA, the effectiveness is expressed in terms of non-
monetary units that describes the desired objective.
– lives saved (life years gained)
- disability days avoided
- cases treated
34. Cost-Effectiveness Analysis
Relates Costs to Health Effects
“Costs” examples : “Outcome” examples :
- hospitalizations, - Events avoided (e.g. MI,
treatment interventions, stroke, or vascular death)
labs, side-effects, study - Life-years saved due to
drug, transportation, lost Costs Outcomes events prevented (e.g. MI,
of productivity, etc. stroke, or vascular death)
“Incremental Cost-Effectiveness Ratio (ICER)”
= Difference in costs divided by difference in health
outcome between two treatment strategies
1. Drummond et al. Ann Int Med 1987; 107(1): 88–92
2. Kobelt G. Health Economics: an introduction to economic evaluation. London: OHE, 2002
35. Framework of the Budget Impact Analysis
CURRENT ENVIRONMENT NEW ENVIRONMENT
New
KEY FACTOR IMPACT ON
Total Population Total Population
Incidence (For
Incidence Preventive
Prevalence interventions ) New
Sick Population Sick Population
% diagnosed Diagnosis
% treated Treatment
New
Target Population Target Population
Current way of Hospitalization,
treatment Follow-up, etc.
New
Resources Utilization Resources Utilization
New therapy/
Unit costs
procedure
New
Cost of Illness DIFERENCE Cost of Illness
Budget Impact
36. Definition of Model
• “A model is a logical mathematical
framework that permits the integration
of facts and values, and that links these
data to outcomes that are of interest to
health-care decision makers.”
Fonte: Weinstein MC, O'Brien B, Hornberger J, et al. Principles of good practice of decision
analytic modeling in health care evaluation: Report of the ISPOR Task Force on Good Research
Practices-Modeling Studies. Value Health 2003; 6:9-17
39. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Background
Instituto de Ensino e Pesquisa
The general guiding principle of CLAPBio is that
decisions regarding new BioSimilar introduction
should be country-led and grounded in an
appropriate comparative, head to head quality,
non-clinical and clinical studies.
40. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Background
Instituto de Ensino e Pesquisa
Central to the CLAPBio approach is the formation
of a regional team, involving collaborations across
multiple organizations – regulatory authorities,
healthcare organizations, international academic
institutions, medical specialities associations.
41. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
CLAPBio’s goal
Instituto de Ensino e Pesquisa
The CLAPBio’s goal is to strengthen the
national capacity to make informed, in
an appropriate comparative, head to
head quality, non-clinical and clinical
studies decisions regarding BioSimilar
introduction.
42. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
CLAPBio’s objectives
Instituto de Ensino e Pesquisa
Strengthen infrastructure for decision-makers
Develop tools for provide training to national
multidisciplinary teams
Develop an Economic Model for BioSimilar in
Latin America
43. Universidade do Estado do Rio de Janeiro
CLAPBio collaboration
Policlínica Piquet Carneiro
Instituto de Ensino e Pesquisa
with LA Countries
Conduct specific studies in the Latin American,
considering each country’s specificity
Provide technical support to national multidisciplinary
teams in regulatory and economic evaluations on
BioSimilars in various countries in Latin America
Support LA Countries in providing training through
workshops and long distance learning on regulatory and
economic analysis
44. Universidade do Estado do Rio de Janeiro
Collaboration
Policlínica Piquet Carneiro
Instituto de Ensino e Pesquisa
objectives
Methodological guides & instruments for
estimation of health services utilization and costs
Acceptable country-level data ranges for model
parameters
Model to evaluate impact of BioSimilar
45. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Strengthening infrastructure
Instituto de Ensino e Pesquisa
for decision-making
Launch an advisory board from opinion
leaders
Build a research center to examine price
trajectories that might develop over time
46. Universidade do Estado do Rio de Janeiro
Develop an Economic Model
Policlínica Piquet Carneiro
Instituto de Ensino e Pesquisa
for Biosimilar in Latin America
How much price competition can we expect
from Biosimilars in Latin America?
Models of market entry and pricing in Latin
America
Forecasts about the impact of Biosimilars in
Latin America
47. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Strengthening infrastructure
Instituto de Ensino e Pesquisa
for decision-making
The implementation of the CLAPBio Initiative’s plan of
work will result in several products, including but not
limited to: development of models for BioSimilar studies,
data collection tools; regional training workshops; direct
technical support to individual countries that make a
request to CLAPBio; development of a regional network
of academic CLAPBio Centers; development of the web-
based CLAPBio e-Support Center; and technical support
for National Regulatory Authorities .
48. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Strengthening infrastructure
Instituto de Ensino e Pesquisa
for decision-making
This approach will be supported by a
regional network of CLAPBio Centers based
in academic institutions across Latin
America
49. Universidade do Estado do Rio de Janeiro
Policlínica Piquet Carneiro
Developing de Ensino e Pesquisa and
Instituto CLAPBio models
tools, and provide training
The CLAPBio initiative will establish the
CLAPBio e-Support Center
(www.clapbio.com.br) to disseminate current
activities, online learning courses and links to
relevant literature
50. Universidade do Estado do Rio de Janeiro
Universidade do Estado do Carneiro
Policlínica Piquet Rio de Janeiro
Departamento de Clínica Médica
Instituto de Ensino e Pesquisa
Centro Latino Americano de Pesquisa em Biológicos
Thank you
Denizar Vianna