Filter by Categories
Aged care
Budgets
Federal Budget 2024-25
Federal Budget 2023-2024
Federal Budget October 2022
Federal Budget 2022-23
Federal Budget 2021-22
Climate and health
#HealthyCOP29
Climate emergency
Healthcare sustainability
Heatwaves
National Health and Climate Strategy
#HealthyCOP28
#HealthyCOP27
#HealthyCOP26
#CoveringClimateNow
COVID collection
COVID-19
Long COVID
COVIDwrap
COVID SNAPS
#JusticeCOVID
Caring for the Frontline
COVIDglobalMHseries
Croakey Conference News Service
#WICC2024
#HealthierSocieties
#DigitalDeterminants24
#iDEA24
#ASMIRT2024
#EACH24
#CHFtalks
#SARRAH2024
#GreenHealthForum24
Croakey Professional Services
Sponsored content
NHLF series
#KidneyCareTogether
ACSQHC series
ACSQHC series 2022
ACSQHC series 2021
ACSQHC series 2020
ACSQHC series 2019
CATSINaM 25 Years
Croakey projects
@WePublicHealth 2024
#ChurchillDeepEnd
Planetary Health Equity Hothouse 2024
Summer reading 2023-2024
The Zap
#CroakeyLIVE #DigitalNationBuilding
#CroakeyLIVE #VoiceForHealth
#PHAAThinkTank2023
The Health Wrap
ICYMI
@WePublicHealth
@WePublicHealth2023
#CroakeyVOICES
#SpeakingOurMinds
Croakey longreads
#CroakeyREAD
CroakeyEXPLORE
CroakeyGO
#CroakeyGO #NavigatingHealth
#GamblingHarms
#HeatwaveHealth
Mapping CroakeyGo
Determinants of health
Environmental determinants of health
Social determinants of health
Education
Discrimination
Housing
Internet access
Justice and policing
Justice Reinvestment
Newstart/JobSeeker
Poverty
Racism
Social policy
Commercial determinants of health
Alcohol
Arms industry
Digital platforms
Food and beverages
Fossil fuels
Gambling
Pharmaceutical industry
Plain packaging
Sugar tax
Tobacco
Vaping
Disasters and extreme weather events
Disasters
Extreme weather events
Bushfires
Bushfire-emergency 2019-2020
Floods 2023
Floods 2022
Floods 2021
Floods 2011
Donor-funded journalism
Donor-funded journalism – 2024
Donor-funded journalism – 2023
Donor-funded journalism – 2022
Donor-funded journalism – 2021
Donor-funded journalism – 2020
Elections
lutruwita/Tasmania 2024 election
NT election 2024
Queensland election 2024
United States election 2024
Federal election 2025
#NSWvotesHealth2023
Victorian election 2022
Federal Election 2022
The Election Wrap 2022
SA election 2022
WA election 2021
Tasmanian election 2021
First Nations
Indigenous health
Community controlled sector
Cultural determinants of health
Cultural safety
Indigenous education
Social and emotional wellbeing
Uluru Statement
The Voice
Lowitja Institute
NT Intervention
WA community closures
Acknowledgement
#CTG10
#NTRC
#RCIADIC30Years
General health matters
Abortion
Cancer
Cardiovascular disease
Child health
Chronic conditions
Consumer health matters
Death and dying
Diabetes
Disabilities
Euthanasia
Fetal Alcohol Spectrum Disorders (FASD)
Genetics
HIV/AIDS
HRT
Infectious diseases
Influenza
LGBTQIA+
Medical marijuana
Men's health
Mental health
Mpox
Non communicable diseases
Oral health
Organ transplants
Pain
Pregnancy and childbirth
Sexual health
Suicide
Swine flu
Trauma
Women's health
Youth health
Global health matters
Asylum seeker and refugee health
Conflict and war
Gaza conflict
Global health
WHO
Ebola
NHS
#WorldInTurmoil
Health policy and systems
Co-design
Health financing and costs
Health reform
Health regulation
Medicare 40 Years
MyMedicare
National Health Performance Authority
Pharmaceutical Benefits Scheme
Private health insurance
Royal Commissions
TGA
Workforce matters
Strengthening Medicare Taskforce 2022
National Commission of Audit 2014
Healthcare
Adverse events
Allied healthcare
Australian Medical Association
Choosing Wisely
cohealth
Complementary medicines
Conflicts of interest
Co-payments
Digital technology
E-health
Emergency departments and care
Equally Well
General practice
Health Care Homes
Health ethics
Hospitals
International medical graduates
Medicare Locals
MyHospitals website
Naturopathy
NDIS
Nursing and midwifery
Out of pocket costs
Palliative care
Paramedics
Pathology
Pharmacy
Primary healthcare
Primary Health Networks
Rural and remote health
Safety and quality of healthcare and aged care
Screening
Social prescribing
Surgery
Telehealth
Tests
Media and health
Media-related issues
Health & medical marketing
Misinformation and disinformation
Public interest journalism
Social media and healthcare
The Conversation
Media Doctor Australia
News about Croakey
Croakey Funding Drive June 2024
Public health and population health
Air pollution
Artificial intelligence
Australian Centre for Disease Control
Government 2.0
Gun control
Health communications
Health impact assessment
Health in All Policies
Health inequalities
Health literacy
Human rights
Illicit drugs
Injuries
Legal issues
Marriage equality
Nanny state
National Preventive Health Agency
Obesity
Occupational health
Physical activity
Prevention
Public health
Road safety
Sport
Transport
Vaccination
VicHealth
Violence
Web 2.0
Weight loss products
#PreventiveHealthStrategy
#UnmetNeedsinPublicHealth
Research matters
Cochrane Collaboration
Evidence-based issues
Health and medical education
Health and medical research
NHMRC
#MRFFtransparency
The Croakey Archives
#cripcroakey
#HealthEquity16
#HealthMatters
#IHMayDay (all years)
#IHMayDay 2014
#IHMayDay15
#IHMayday16
#IHMayDay17
#IHMayDay18
#LoveRural 2014
Croakey Conference News Service 2013 – 2023
2023 Conferences
#GreenHealthForum23
#hpsymposium2023
#NMS23
#HEAL2023
#ASMIRT2023
#NSPC23
Our Democracy Forum
#AskMSF
#Lowitja2023
2022 Conferences
#16nrhc
#GreenHealthForum22
#Heal2022
#ICEM22
#NAISA22
#NNF2022
#RANZCP2022
#RethinkAddiction
#RTP22
GiantSteps22
Equally Well 2022 Symposium
Choosing Wisely National Meeting 2022
2021 conferences
#21OPCC
#BackToTheFire
#FoodGovernance2021
#GiantSteps21
#GreenHealthForum21
#HealthClimateSolutions21
#HearMe21
#IndigenousClimateJustice21
#NNF2021
#RANZCP2021
#ShiftingGearsSummit
#ValueBasedCare
#WCepi2021
#YHFSummit
2020 conferences
#2020ResearchExcellence
#Govern4Health
#HealthReImagined
#SAHeapsUnfair
2019 Conferences
#ACEM19
#CPHCE19
#EquallyWellAust
#GiantSteps19
#HealthAdvocacyWIM
#KTthatWorks
#LowitjaConf2019
#MHAgeing
#NNF2019
#OKtoAsk2019
#RANZCOG19
#RANZCP2019
#ruralhealthconf
#VMIAC2019
#WHOcollabAHPRA
2018 conferences
#6rrhss
#ACEM18
#AHPA2018
#ATSISPC18
#CPHCE
#MHED18
#NDISMentalHealth
#Nurseforce
#OKToAsk2018
#RANZCOG18
#ResearchIntoPolicy
#VHAawards
#VMIACAwards18
#WISPC18
2017 conferences
#17APCC
#ACEM17
#AIDAconf2017
#BTH20
#CATSINaM17
#ClimateHealthStrategy
#IAHAConf17
#IDS17
#LBQWHC17
#LivingOurWay
#OKtoAskAu
#OTCC2017
#ResearchTranslation17
#TheMHS2017
#VMIACConf17
#WCPH2017
Australian Palliative Care Conference
2016 conferences
#AHHAsim16
#AHMRC16
#ANROWS2016
#ATSISPEP
#AusCanIndigenousWellness
#cphce2016
#CPHCEforum16
#CRANAplus2016
#IAMRA2016
#LowitjaConf2016
#PreventObesity16
#TowardsRecovery
#VMIAC16
#WearablesCEH
#WICC2016
2015 conferences
#CPHCEforum
#CRANAplus15
#HSR15
#NRHC15
#OTCC15
Population Health Congress 2015
2014 conferences
#IPCHIV14
AIDA Conference 2014
Congress Lowitja 2014
CRANAplus conference 2014
Cultural Solutions - Healing Foundation forum 2014
Lowitja Institute Continuous Quality Improvement conference 2014
National Suicide Prevention Conference 2014
Racism and children/youth health symposium 2014
Rural & Remote Health Scientific Symposium 2014
2013 conferences
Australian Centre for Health Services Innovation Forum 2013
Australian Health Promotion Association Conference 2013
Closing the Credibility Gap 2013
CRANAplus Conference 2013
FASD Conference 2013
Health Workforce Australia 2013
International Health Literacy Network Conference 2013
NACCHO Summit 2013
National Rural Health Conference 2013
Oceania EcoHealth Symposium 2013
PHAA conference 2013
Croakey Professional Services archive
#CommunityControl
#CommunityControl Twitter Festival
#COVIDthinktank21
Lowitja Indigenous knowledge translation series
Croakey projects archive
#PHAAThinkTank 2022
Summer reading 2022-2023
#CommunityMatters
#CroakeyFundingDrive 2022
#CroakeyLIVE #Budget2021Health
#CroakeyLIVE #USvotesHealth
#CroakeyLIVE Federal election 2022
#CroakeyYOUTH
#HousingJusticeAus
#IndigenousHealthSummit
#IndigenousNCDs
#JustClimate
#JustJustice
#LookingLocal
#OutOfPocket
#OutOfTheBox
#RuralHealthJustice
#TalkingTeeth
@WePublicHealth2022
@WePublicHealth2021
@WePublicHealth2020
AroundTheTraps
Croakey register of influence
Croakey Register of Influencers in Public Health
Croakey Register of Unreleased Documents
Gavin Mooney
Inside Story
Journal Watch
Naked Doctor
Poems of Public Health
Summer reading 2021-2022
Summer reading 2020-2021
Summer Reading 2019-2020
Summer Reading 2017-2018
Summer Reading 2016-2017
The Koori Woman
TOO MUCH of a Good Thing
Wonky Health
CroakeyGO archive 2017 – 2018
CroakeyGo 2018
#CroakeyGO #QuantumWords 2018
#CroakeyGO #VicVotes 2018
#CroakeyGO Albury 2018
#CroakeyGO Callan Park 2018
#CroakeyGO Carnarvon 2018
#CroakeyGO Marrickville 2018
#CroakeyGO Palm Island 2018
CroakeyGo 2017
#CroakeyGO Adelaide 2017
#CroakeyGO Melbourne 2017
#CroakeyGO Newcastle 2017
#CroakeyGO Sydney 2017
Elections and Budgets 2013 – 2021
#QldVotesHealth 2020
Budget2020Health
Federal Budget 2020-21
Federal Budget 2019-20
#AusVotesHealth Twitter Festival 2019
#Health4NSW
Federal Election 2019
NSW Election 2019
Federal Budget 2018-19
Federal Budget 2017/18
NZ Election 2017
Federal Budget 2016-17
Federal Election 2016
#HealthElection16
NT Election 2016
Federal Budget 2015-16
Qld Election 2015
NSW Election 2015
Federal Budget 2014-15
Victorian Election 2014
Federal Budget 2013-14
Federal Election 2013
Federal Budget 2012-2013
Federal Budget 2011
Federal Budget 2010
Federal Election 2010
Federal Budget 2009-2010
Support non-profit public interest journalism
Filter by Categories
Aged care
Budgets
Federal Budget 2024-25
Federal Budget 2023-2024
Federal Budget October 2022
Federal Budget 2022-23
Federal Budget 2021-22
Climate and health
#HealthyCOP29
Climate emergency
Healthcare sustainability
Heatwaves
National Health and Climate Strategy
#HealthyCOP28
#HealthyCOP27
#HealthyCOP26
#CoveringClimateNow
COVID collection
COVID-19
Long COVID
COVIDwrap
COVID SNAPS
#JusticeCOVID
Caring for the Frontline
COVIDglobalMHseries
Croakey Conference News Service
#WICC2024
#HealthierSocieties
#DigitalDeterminants24
#iDEA24
#ASMIRT2024
#EACH24
#CHFtalks
#SARRAH2024
#GreenHealthForum24
Croakey Professional Services
Sponsored content
NHLF series
#KidneyCareTogether
ACSQHC series
ACSQHC series 2022
ACSQHC series 2021
ACSQHC series 2020
ACSQHC series 2019
CATSINaM 25 Years
Croakey projects
@WePublicHealth 2024
#ChurchillDeepEnd
Planetary Health Equity Hothouse 2024
Summer reading 2023-2024
The Zap
#CroakeyLIVE #DigitalNationBuilding
#CroakeyLIVE #VoiceForHealth
#PHAAThinkTank2023
The Health Wrap
ICYMI
@WePublicHealth
@WePublicHealth2023
#CroakeyVOICES
#SpeakingOurMinds
Croakey longreads
#CroakeyREAD
CroakeyEXPLORE
CroakeyGO
#CroakeyGO #NavigatingHealth
#GamblingHarms
#HeatwaveHealth
Mapping CroakeyGo
Determinants of health
Environmental determinants of health
Social determinants of health
Education
Discrimination
Housing
Internet access
Justice and policing
Justice Reinvestment
Newstart/JobSeeker
Poverty
Racism
Social policy
Commercial determinants of health
Alcohol
Arms industry
Digital platforms
Food and beverages
Fossil fuels
Gambling
Pharmaceutical industry
Plain packaging
Sugar tax
Tobacco
Vaping
Disasters and extreme weather events
Disasters
Extreme weather events
Bushfires
Bushfire-emergency 2019-2020
Floods 2023
Floods 2022
Floods 2021
Floods 2011
Donor-funded journalism
Donor-funded journalism – 2024
Donor-funded journalism – 2023
Donor-funded journalism – 2022
Donor-funded journalism – 2021
Donor-funded journalism – 2020
Elections
lutruwita/Tasmania 2024 election
NT election 2024
Queensland election 2024
United States election 2024
Federal election 2025
#NSWvotesHealth2023
Victorian election 2022
Federal Election 2022
The Election Wrap 2022
SA election 2022
WA election 2021
Tasmanian election 2021
First Nations
Indigenous health
Community controlled sector
Cultural determinants of health
Cultural safety
Indigenous education
Social and emotional wellbeing
Uluru Statement
The Voice
Lowitja Institute
NT Intervention
WA community closures
Acknowledgement
#CTG10
#NTRC
#RCIADIC30Years
General health matters
Abortion
Cancer
Cardiovascular disease
Child health
Chronic conditions
Consumer health matters
Death and dying
Diabetes
Disabilities
Euthanasia
Fetal Alcohol Spectrum Disorders (FASD)
Genetics
HIV/AIDS
HRT
Infectious diseases
Influenza
LGBTQIA+
Medical marijuana
Men's health
Mental health
Mpox
Non communicable diseases
Oral health
Organ transplants
Pain
Pregnancy and childbirth
Sexual health
Suicide
Swine flu
Trauma
Women's health
Youth health
Global health matters
Asylum seeker and refugee health
Conflict and war
Gaza conflict
Global health
WHO
Ebola
NHS
#WorldInTurmoil
Health policy and systems
Co-design
Health financing and costs
Health reform
Health regulation
Medicare 40 Years
MyMedicare
National Health Performance Authority
Pharmaceutical Benefits Scheme
Private health insurance
Royal Commissions
TGA
Workforce matters
Strengthening Medicare Taskforce 2022
National Commission of Audit 2014
Healthcare
Adverse events
Allied healthcare
Australian Medical Association
Choosing Wisely
cohealth
Complementary medicines
Conflicts of interest
Co-payments
Digital technology
E-health
Emergency departments and care
Equally Well
General practice
Health Care Homes
Health ethics
Hospitals
International medical graduates
Medicare Locals
MyHospitals website
Naturopathy
NDIS
Nursing and midwifery
Out of pocket costs
Palliative care
Paramedics
Pathology
Pharmacy
Primary healthcare
Primary Health Networks
Rural and remote health
Safety and quality of healthcare and aged care
Screening
Social prescribing
Surgery
Telehealth
Tests
Media and health
Media-related issues
Health & medical marketing
Misinformation and disinformation
Public interest journalism
Social media and healthcare
The Conversation
Media Doctor Australia
News about Croakey
Croakey Funding Drive June 2024
Public health and population health
Air pollution
Artificial intelligence
Australian Centre for Disease Control
Government 2.0
Gun control
Health communications
Health impact assessment
Health in All Policies
Health inequalities
Health literacy
Human rights
Illicit drugs
Injuries
Legal issues
Marriage equality
Nanny state
National Preventive Health Agency
Obesity
Occupational health
Physical activity
Prevention
Public health
Road safety
Sport
Transport
Vaccination
VicHealth
Violence
Web 2.0
Weight loss products
#PreventiveHealthStrategy
#UnmetNeedsinPublicHealth
Research matters
Cochrane Collaboration
Evidence-based issues
Health and medical education
Health and medical research
NHMRC
#MRFFtransparency
The Croakey Archives
#cripcroakey
#HealthEquity16
#HealthMatters
#IHMayDay (all years)
#IHMayDay 2014
#IHMayDay15
#IHMayday16
#IHMayDay17
#IHMayDay18
#LoveRural 2014
Croakey Conference News Service 2013 – 2023
2023 Conferences
#GreenHealthForum23
#hpsymposium2023
#NMS23
#HEAL2023
#ASMIRT2023
#NSPC23
Our Democracy Forum
#AskMSF
#Lowitja2023
2022 Conferences
#16nrhc
#GreenHealthForum22
#Heal2022
#ICEM22
#NAISA22
#NNF2022
#RANZCP2022
#RethinkAddiction
#RTP22
GiantSteps22
Equally Well 2022 Symposium
Choosing Wisely National Meeting 2022
2021 conferences
#21OPCC
#BackToTheFire
#FoodGovernance2021
#GiantSteps21
#GreenHealthForum21
#HealthClimateSolutions21
#HearMe21
#IndigenousClimateJustice21
#NNF2021
#RANZCP2021
#ShiftingGearsSummit
#ValueBasedCare
#WCepi2021
#YHFSummit
2020 conferences
#2020ResearchExcellence
#Govern4Health
#HealthReImagined
#SAHeapsUnfair
2019 Conferences
#ACEM19
#CPHCE19
#EquallyWellAust
#GiantSteps19
#HealthAdvocacyWIM
#KTthatWorks
#LowitjaConf2019
#MHAgeing
#NNF2019
#OKtoAsk2019
#RANZCOG19
#RANZCP2019
#ruralhealthconf
#VMIAC2019
#WHOcollabAHPRA
2018 conferences
#6rrhss
#ACEM18
#AHPA2018
#ATSISPC18
#CPHCE
#MHED18
#NDISMentalHealth
#Nurseforce
#OKToAsk2018
#RANZCOG18
#ResearchIntoPolicy
#VHAawards
#VMIACAwards18
#WISPC18
2017 conferences
#17APCC
#ACEM17
#AIDAconf2017
#BTH20
#CATSINaM17
#ClimateHealthStrategy
#IAHAConf17
#IDS17
#LBQWHC17
#LivingOurWay
#OKtoAskAu
#OTCC2017
#ResearchTranslation17
#TheMHS2017
#VMIACConf17
#WCPH2017
Australian Palliative Care Conference
2016 conferences
#AHHAsim16
#AHMRC16
#ANROWS2016
#ATSISPEP
#AusCanIndigenousWellness
#cphce2016
#CPHCEforum16
#CRANAplus2016
#IAMRA2016
#LowitjaConf2016
#PreventObesity16
#TowardsRecovery
#VMIAC16
#WearablesCEH
#WICC2016
2015 conferences
#CPHCEforum
#CRANAplus15
#HSR15
#NRHC15
#OTCC15
Population Health Congress 2015
2014 conferences
#IPCHIV14
AIDA Conference 2014
Congress Lowitja 2014
CRANAplus conference 2014
Cultural Solutions - Healing Foundation forum 2014
Lowitja Institute Continuous Quality Improvement conference 2014
National Suicide Prevention Conference 2014
Racism and children/youth health symposium 2014
Rural & Remote Health Scientific Symposium 2014
2013 conferences
Australian Centre for Health Services Innovation Forum 2013
Australian Health Promotion Association Conference 2013
Closing the Credibility Gap 2013
CRANAplus Conference 2013
FASD Conference 2013
Health Workforce Australia 2013
International Health Literacy Network Conference 2013
NACCHO Summit 2013
National Rural Health Conference 2013
Oceania EcoHealth Symposium 2013
PHAA conference 2013
Croakey Professional Services archive
#CommunityControl
#CommunityControl Twitter Festival
#COVIDthinktank21
Lowitja Indigenous knowledge translation series
Croakey projects archive
#PHAAThinkTank 2022
Summer reading 2022-2023
#CommunityMatters
#CroakeyFundingDrive 2022
#CroakeyLIVE #Budget2021Health
#CroakeyLIVE #USvotesHealth
#CroakeyLIVE Federal election 2022
#CroakeyYOUTH
#HousingJusticeAus
#IndigenousHealthSummit
#IndigenousNCDs
#JustClimate
#JustJustice
#LookingLocal
#OutOfPocket
#OutOfTheBox
#RuralHealthJustice
#TalkingTeeth
@WePublicHealth2022
@WePublicHealth2021
@WePublicHealth2020
AroundTheTraps
Croakey register of influence
Croakey Register of Influencers in Public Health
Croakey Register of Unreleased Documents
Gavin Mooney
Inside Story
Journal Watch
Naked Doctor
Poems of Public Health
Summer reading 2021-2022
Summer reading 2020-2021
Summer Reading 2019-2020
Summer Reading 2017-2018
Summer Reading 2016-2017
The Koori Woman
TOO MUCH of a Good Thing
Wonky Health
CroakeyGO archive 2017 – 2018
CroakeyGo 2018
#CroakeyGO #QuantumWords 2018
#CroakeyGO #VicVotes 2018
#CroakeyGO Albury 2018
#CroakeyGO Callan Park 2018
#CroakeyGO Carnarvon 2018
#CroakeyGO Marrickville 2018
#CroakeyGO Palm Island 2018
CroakeyGo 2017
#CroakeyGO Adelaide 2017
#CroakeyGO Melbourne 2017
#CroakeyGO Newcastle 2017
#CroakeyGO Sydney 2017
Elections and Budgets 2013 – 2021
#QldVotesHealth 2020
Budget2020Health
Federal Budget 2020-21
Federal Budget 2019-20
#AusVotesHealth Twitter Festival 2019
#Health4NSW
Federal Election 2019
NSW Election 2019
Federal Budget 2018-19
Federal Budget 2017/18
NZ Election 2017
Federal Budget 2016-17
Federal Election 2016
#HealthElection16
NT Election 2016
Federal Budget 2015-16
Qld Election 2015
NSW Election 2015
Federal Budget 2014-15
Victorian Election 2014
Federal Budget 2013-14
Federal Election 2013
Federal Budget 2012-2013
Federal Budget 2011
Federal Budget 2010
Federal Election 2010
Federal Budget 2009-2010

A call for clarity in policy around drugs known as “biosimilars”

The Pharmaceutical Benefits Advisory Committee and the Therapeutic Goods Administration have been urged to clarify their policies around “biosimilars” – drugs which act in the same way as patented biological drugs, although they may not be exactly the same.

Dr Ruth Lopert, who was the TGA’s Principal Medical Adviser from 2008-2011 and Director of the Pharmaceutical Policy Taskforce in the Department of Health in 2005-06, explains some of the complexities for regulators and consumers raised by biosimilar products.

****

Switching, interchangeability, substitution: TGA and PBAC confusion over biosimilar policy and nomenclature

Ruth Lopert writes:

Despite several biosimilar products already approved by the TGA and available in Australia, there is ongoing confusion over biosimilar funding policy.

TGA is currently revising its position on the evaluation and nomenclature of biosimilars, and PBAC recently released two statements regarding the potential for biosimilar substitution at pharmacy (see here).

Unfortunately, neither of the PBAC’s statements provides adequate clarity as to its position or processes, and both are causing concern among patient and provider groups.

There is clearly a great deal at stake. Previously substitution at pharmacy has been critical to the ability of small molecule generics to gain market share.

The problem with biosimilars is that unlike generic versions of small molecule medicines, they cannot be declared to be bioequivalent by the TGA – bioequivalence previously being an implied pre-requisite for ‘A’ flagging by PBAC.

Because biologics – products biotechnologically derived from living organisms – are by their nature invariably complex, and can be exquisitely sensitive to even minor changes in manufacturing processes – the assessment of a biosimilar product is both more extensive and more complex than a small molecule generic.

A key issue in determining biosimilarity is assessing comparability in safety and efficacy, as well as in immunogenicity – the capacity to induce an immune-mediated response, which could, for example, lead to reduced efficacy through the production of neutralizing antibodies, or lead to the development of more serious effects impacting the safety of the product.

PBAC’s first statement dated April 2015, caused widespread concern as it stated the Committee’s default position would be that:

“…biosimilar products would be “a” flagged, and therefore suitable for substitution at the pharmacy level, where the data are supportive of this conclusion.. (and that)  relevant considerations in establishing that a biosimilar product could be “a” flagged  (would include ) ..(A)bsence of data to suggest significant differences in clinical … effectiveness or safety compared with the originator product;… (and)… (A) vailability of data to support switching between the originator product and the biosimilar product…”

But of course absence of evidence isn’t evidence of absence.

In an attempt to clarify its position, the PBAC issue a second statement on June 18th saying: 

“..if the biosimilar is approved by the Therapeutic Goods Administration as a safe and equally effective treatment compared to another drug, the PBAC will then consider listing the biosimilar drug on the PBS. During this assessment process, the PBAC will also consider whether the biosimilar drug should be listed to allow substitution by a doctor or pharmacist. This will be done on a case by case basis.”

Unfortunately, neither statement identifies the nature of the evidence required to support substitution, nor which entity will be responsible for evaluating it.

What’s now needed is statement from the TGA as to whether (and if so, how) it is planning to assess (and presumably assert, if satisfied) the safety of repeat switching.

PBAC should also issue a further statement distinguishing between interchangeability at the point of first prescription vs substitution on repeat dispensing.

For a product deemed biosimilar by the TGA there should be clinical equipoise about the choice between a biosimilar or originator product at treatment initiation – and therefore there could also be discretion at the point of dispensing unless explicitly precluded by the prescriber.

However, unless there is adequate evidence of the safety of repeat switching, the initially dispensed product should continue to be the one dispensed when a repeat prescription is presented. This could perhaps be denoted by a different flag in the PBS Schedule.

There’s as yet no consensus internationally on standards for assessing the safety of repeat switching – which is of particular relevance to monoclonal antibodies.

Notwithstanding the fact that concerns about the immunogenicity of repeat switching are largely theoretical, confidence in product safety should arguably should be the prerequisite for substitution at pharmacy and the designation of an “a” flag.

• Ruth Lopert is currently based in Washington DC where she is Deputy Director, Pharmaceutical Policy & Strategy at Management Sciences for Health, and an adjunct professor in the Department of Health Policy & Management at George Washington University. She was TGA’s Principal Medical Adviser from 2008-2011 and Director of the Pharmaceutical Policy Taskforce in DoH in 2005-06.

 

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Search by: Categories or tags

Filter by Categories
Aged care
Budgets
Federal Budget 2024-25
Federal Budget 2023-2024
Federal Budget October 2022
Federal Budget 2022-23
Federal Budget 2021-22
Climate and health
#HealthyCOP29
Climate emergency
Healthcare sustainability
Heatwaves
National Health and Climate Strategy
#HealthyCOP28
#HealthyCOP27
#HealthyCOP26
#CoveringClimateNow
COVID collection
COVID-19
Long COVID
COVIDwrap
COVID SNAPS
#JusticeCOVID
Caring for the Frontline
COVIDglobalMHseries
Croakey Conference News Service
#WICC2024
#HealthierSocieties
#DigitalDeterminants24
#iDEA24
#ASMIRT2024
#EACH24
#CHFtalks
#SARRAH2024
#GreenHealthForum24
Croakey Professional Services
Sponsored content
#IndigenousEvaluation
NHLF series
#KidneyCareTogether
ACSQHC series
ACSQHC series 2022
ACSQHC series 2021
ACSQHC series 2020
ACSQHC series 2019
CATSINaM 25 Years
Croakey projects
@WePublicHealth 2024
#ChurchillDeepEnd
Planetary Health Equity Hothouse 2024
Summer reading 2023-2024
The Zap
#CroakeyLIVE #DigitalNationBuilding
#CroakeyLIVE #VoiceForHealth
#PHAAThinkTank2023
The Health Wrap
ICYMI
@WePublicHealth
@WePublicHealth2023
#CroakeyVOICES
#SpeakingOurMinds
Croakey longreads
#CroakeyREAD
CroakeyEXPLORE
CroakeyGO
#CroakeyGO #NavigatingHealth
#GamblingHarms
#HeatwaveHealth
Mapping CroakeyGo
Determinants of health
Environmental determinants of health
Social determinants of health
Education
Discrimination
Housing
Internet access
Justice and policing
Justice Reinvestment
Newstart/JobSeeker
Poverty
Racism
Social policy
Commercial determinants of health
Alcohol
Arms industry
Digital platforms
Food and beverages
Fossil fuels
Gambling
Pharmaceutical industry
Plain packaging
Sugar tax
Tobacco
Vaping
Disasters and extreme weather events
Disasters
Extreme weather events
Bushfires
Bushfire-emergency 2019-2020
Floods 2023
Floods 2022
Floods 2021
Floods 2011
Donor-funded journalism
Donor-funded journalism – 2024
Donor-funded journalism – 2023
Donor-funded journalism – 2022
Donor-funded journalism – 2021
Donor-funded journalism – 2020
Elections
lutruwita/Tasmania 2024 election
NT election 2024
Queensland election 2024
United States election 2024
Federal election 2025
#NSWvotesHealth2023
Victorian election 2022
Federal Election 2022
The Election Wrap 2022
SA election 2022
WA election 2021
Tasmanian election 2021
First Nations
Indigenous health
Community controlled sector
Cultural determinants of health
Cultural safety
Indigenous education
Social and emotional wellbeing
Uluru Statement
The Voice
Lowitja Institute
NT Intervention
WA community closures
Acknowledgement
#CTG10
#NTRC
#RCIADIC30Years
General health matters
Abortion
Cancer
Cardiovascular disease
Child health
Chronic conditions
Consumer health matters
Death and dying
Diabetes
Disabilities
Euthanasia
Fetal Alcohol Spectrum Disorders (FASD)
Genetics
HIV/AIDS
HRT
Infectious diseases
Influenza
LGBTQIA+
Medical marijuana
Men's health
Mental health
Mpox
Non communicable diseases
Oral health
Organ transplants
Pain
Pregnancy and childbirth
Sexual health
Suicide
Swine flu
Trauma
Women's health
Youth health
Global health matters
Asylum seeker and refugee health
Conflict and war
Gaza conflict
Global health
WHO
Ebola
NHS
#WorldInTurmoil
Health policy and systems
Co-design
Health financing and costs
Health reform
Health regulation
Medicare 40 Years
MyMedicare
National Health Performance Authority
Pharmaceutical Benefits Scheme
Private health insurance
Royal Commissions
TGA
Workforce matters
Strengthening Medicare Taskforce 2022
National Commission of Audit 2014
Healthcare
Adverse events
Allied healthcare
Australian Medical Association
Choosing Wisely
cohealth
Complementary medicines
Conflicts of interest
Co-payments
Digital technology
E-health
Emergency departments and care
Equally Well
General practice
Health Care Homes
Health ethics
Hospitals
International medical graduates
Medicare Locals
MyHospitals website
Naturopathy
NDIS
Nursing and midwifery
Out of pocket costs
Palliative care
Paramedics
Pathology
Pharmacy
Primary healthcare
Primary Health Networks
Rural and remote health
Safety and quality of healthcare and aged care
Screening
Social prescribing
Surgery
Telehealth
Tests
Media and health
Media-related issues
Health & medical marketing
Misinformation and disinformation
Public interest journalism
Social media and healthcare
The Conversation
Media Doctor Australia
News about Croakey
Croakey Funding Drive June 2024
Public health and population health
Air pollution
Artificial intelligence
Australian Centre for Disease Control
Government 2.0
Gun control
Health communications
Health impact assessment
Health in All Policies
Health inequalities
Health literacy
Human rights
Illicit drugs
Injuries
Legal issues
Marriage equality
Nanny state
National Preventive Health Agency
Obesity
Occupational health
Physical activity
Prevention
Public health
Road safety
Sport
Transport
Vaccination
VicHealth
Violence
Web 2.0
Weight loss products
#PreventiveHealthStrategy
#UnmetNeedsinPublicHealth
Research matters
Cochrane Collaboration
Evidence-based issues
Health and medical education
Health and medical research
NHMRC
#MRFFtransparency
The Croakey Archives
#cripcroakey
#HealthEquity16
#HealthMatters
#IHMayDay (all years)
#IHMayDay 2014
#IHMayDay15
#IHMayday16
#IHMayDay17
#IHMayDay18
#LoveRural 2014
Croakey Conference News Service 2013 – 2023
2023 Conferences
#GreenHealthForum23
#hpsymposium2023
#NMS23
#HEAL2023
#ASMIRT2023
#NSPC23
Our Democracy Forum
#AskMSF
#Lowitja2023
2022 Conferences
#16nrhc
#GreenHealthForum22
#Heal2022
#ICEM22
#NAISA22
#NNF2022
#RANZCP2022
#RethinkAddiction
#RTP22
GiantSteps22
Equally Well 2022 Symposium
Choosing Wisely National Meeting 2022
2021 conferences
#21OPCC
#BackToTheFire
#FoodGovernance2021
#GiantSteps21
#GreenHealthForum21
#HealthClimateSolutions21
#HearMe21
#IndigenousClimateJustice21
#NNF2021
#RANZCP2021
#ShiftingGearsSummit
#ValueBasedCare
#WCepi2021
#YHFSummit
2020 conferences
#2020ResearchExcellence
#Govern4Health
#HealthReImagined
#SAHeapsUnfair
2019 Conferences
#ACEM19
#CPHCE19
#EquallyWellAust
#GiantSteps19
#HealthAdvocacyWIM
#KTthatWorks
#LowitjaConf2019
#MHAgeing
#NNF2019
#OKtoAsk2019
#RANZCOG19
#RANZCP2019
#ruralhealthconf
#VMIAC2019
#WHOcollabAHPRA
2018 conferences
#6rrhss
#ACEM18
#AHPA2018
#ATSISPC18
#CPHCE
#MHED18
#NDISMentalHealth
#Nurseforce
#OKToAsk2018
#RANZCOG18
#ResearchIntoPolicy
#VHAawards
#VMIACAwards18
#WISPC18
2017 conferences
#17APCC
#ACEM17
#AIDAconf2017
#BTH20
#CATSINaM17
#ClimateHealthStrategy
#IAHAConf17
#IDS17
#LBQWHC17
#LivingOurWay
#OKtoAskAu
#OTCC2017
#ResearchTranslation17
#TheMHS2017
#VMIACConf17
#WCPH2017
Australian Palliative Care Conference
2016 conferences
#AHHAsim16
#AHMRC16
#ANROWS2016
#ATSISPEP
#AusCanIndigenousWellness
#cphce2016
#CPHCEforum16
#CRANAplus2016
#IAMRA2016
#LowitjaConf2016
#PreventObesity16
#TowardsRecovery
#VMIAC16
#WearablesCEH
#WICC2016
2015 conferences
#CPHCEforum
#CRANAplus15
#HSR15
#NRHC15
#OTCC15
Population Health Congress 2015
2014 conferences
#IPCHIV14
AIDA Conference 2014
Congress Lowitja 2014
CRANAplus conference 2014
Cultural Solutions - Healing Foundation forum 2014
Lowitja Institute Continuous Quality Improvement conference 2014
National Suicide Prevention Conference 2014
Racism and children/youth health symposium 2014
Rural & Remote Health Scientific Symposium 2014
2013 conferences
Australian Centre for Health Services Innovation Forum 2013
Australian Health Promotion Association Conference 2013
Closing the Credibility Gap 2013
CRANAplus Conference 2013
FASD Conference 2013
Health Workforce Australia 2013
International Health Literacy Network Conference 2013
NACCHO Summit 2013
National Rural Health Conference 2013
Oceania EcoHealth Symposium 2013
PHAA conference 2013
Croakey Professional Services archive
#CommunityControl
#CommunityControl Twitter Festival
#COVIDthinktank21
Healthdirect Australia series 2019
Lowitja Indigenous knowledge translation series
Croakey projects archive
#PHAAThinkTank 2022
Summer reading 2022-2023
#CommunityMatters
#CroakeyFundingDrive 2022
#CroakeyLIVE #Budget2021Health
#CroakeyLIVE #USvotesHealth
#CroakeyLIVE Federal election 2022
#CroakeyYOUTH
#HousingJusticeAus
#IndigenousHealthSummit
#IndigenousNCDs
#JustClimate
#JustJustice
#LookingLocal
#OutOfPocket
#OutOfTheBox
#RuralHealthJustice
#TalkingTeeth
@WePublicHealth2022
@WePublicHealth2021
@WePublicHealth2020
AroundTheTraps
Croakey register of influence
Croakey Register of Influencers in Public Health
Croakey Register of Unreleased Documents
Gavin Mooney
Inside Story
Journal Watch
Naked Doctor
Poems of Public Health
Summer reading 2021-2022
Summer reading 2020-2021
Summer Reading 2019-2020
Summer Reading 2017-2018
Summer Reading 2016-2017
The Koori Woman
TOO MUCH of a Good Thing
Wonky Health
CroakeyGO archive 2017 – 2018
CroakeyGo 2018
#CroakeyGO #QuantumWords 2018
#CroakeyGO #VicVotes 2018
#CroakeyGO Albury 2018
#CroakeyGO Callan Park 2018
#CroakeyGO Carnarvon 2018
#CroakeyGO Marrickville 2018
#CroakeyGO Palm Island 2018
CroakeyGo 2017
#CroakeyGO Adelaide 2017
#CroakeyGO Melbourne 2017
#CroakeyGO Newcastle 2017
#CroakeyGO Sydney 2017
Elections and Budgets 2013 – 2021
#QldVotesHealth 2020
Budget2020Health
Federal Budget 2020-21
Federal Budget 2019-20
#AusVotesHealth Twitter Festival 2019
#Health4NSW
Federal Election 2019
NSW Election 2019
Federal Budget 2018-19
Federal Budget 2017/18
NZ Election 2017
Federal Budget 2016-17
Federal Election 2016
#HealthElection16
NT Election 2016
Federal Budget 2015-16
Qld Election 2015
NSW Election 2015
Federal Budget 2014-15
Victorian Election 2014
Federal Budget 2013-14
Federal Election 2013
Federal Budget 2012-2013
Federal Budget 2011
Federal Budget 2010
Federal Election 2010
Federal Budget 2009-2010

Search the Croakey Archives

Archives
Facebook
X/Twitter
LinkedIn