Biosimilars in Oncology: KOL Insight
Will physicians ever adopt Biosimilars in Oncology?
Sceptical, survival focussed oncologists that make treatment decisions in life or death situations aren't yet ready to accept biosimilars of proven targeted treatments. So what do pharma companies need to do to increase confidence and ensure uptake of biosimilars in this toughest of markets?
Biosimilars in Oncology: KOL Insight spells out the concerns about equivalence, evidence and endpoints with insights into the current challenges from 12 leading North American and European KOLs. Understand what you need to do to convince oncologists to use biosimilars.
'Cost, cost, cost. It's the one and only driver of biosimilar usage in the US.' - US key opinion leader
Answering key questions about oncology biosimilars
KOLs from the US
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Ongoing Benefits
The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord's guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.
Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.
Sceptical, survival focussed oncologists that make treatment decisions in life or death situations aren't yet ready to accept biosimilars of proven targeted treatments. So what do pharma companies need to do to increase confidence and ensure uptake of biosimilars in this toughest of markets?
Biosimilars in Oncology: KOL Insight spells out the concerns about equivalence, evidence and endpoints with insights into the current challenges from 12 leading North American and European KOLs. Understand what you need to do to convince oncologists to use biosimilars.
'Cost, cost, cost. It's the one and only driver of biosimilar usage in the US.' - US key opinion leader
Answering key questions about oncology biosimilars
- Quality of evidence is a hurdle to overcome: What’s worrying KOLs about the evidence available for biosimilars?
- Patient concerns outweigh cost issues: Why do proven results govern treatment choices every time?
- Survival data issues dominate thinking: Why are comparisons with reference products seen as essential by oncologists?
- Treatment setting is a factor: Are there different views on the use and take-up of biosimilars for supportive care v the treatment space?
- Information is hard to find: Why is so little published in key medical journals and is this likely to improve?
- Participation in trials is a low priority: What’s holding back participation in trials that could produce the conclusive evidence oncologists badly want?
- Conflict between prescribers and payers set to continue: How are conflicts between payers and prescribers likely to be resolved?
- Adoption rates: How soon will it be before biosimilars are used more widely in oncology and what other factors are holding this back?
- Conflicting pressures on biosimilar adoption: Oncologists are resisting moves to drive down costs from payers despite increasing treatment outlay
- Oncologists have specific needs: Pharma companies need to understand exactly what evidence is needed to convince physicians to use biosimilar treatments
- More education wanted: The vast majority of physicians want more education on biosimilars both from companies and as continuing medical education
- EU and US at odds over naming conventions and labelling: There are concerns over confusion and traceability in product names
- Biosimilar awareness growing: Awareness is higher in Europe than the US although this is improving with the recent launch of Zarxio (Sandoz)
- Prompt action is needed: Given the time it takes to reach the market, pharma companies need to make sure evidence issues are addressed early
- An in-depth summary of the oncology biosimilars landscape, including details of several high profile late-stage programmes
- The oncology products that biosimilars are targeting
- The economic burden of cancer and the potential solutions biosimilars could offer
- Barriers and drivers for biosimilar adoption in the oncology setting
- Whether oncologists understand the technical, clinical and regulatory aspects of biosimilars
- The likely adoption rates for key therapeutic monoclonal antibodies (mAbs)
KOLs from the US
- Joshua Brody: Assistant Professor of Medicine, Haematology and Medical Oncology, Mount Sinai Hospital, New York, NY.
- Young Kwang Chae: Assistant Professor in Medicine, Haematology and Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL.
- Thai H. Ho: Medical Oncologist, Mayo Clinic, Scottsdale, AZ.
- Philip Lammers: Chief of the Division of Haematology/Oncology at Meharry Medical College, Nashville, TN.
- Bradley J. Monk: Professor in the Department of Obstetrics and Gynaecology, Creighton University School of Medicine, St. Joseph’s Hospital and Medical Center, Phoenix, AZ.
- Igor Puzanov: Associate Professor of Medicine in the Division of Haematology-Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN.
- Anonymous German KOL: This physician specialises in haematology, oncology and tumour immunology.
- Mark Drummond: Lead Clinician, Blood Cancers, West of Scotland Managed Clinical Network for Haemato-Oncology, NHS Greater Glasgow and Clyde.
- Rebecca Kristeleit: Consultant Medical Oncologist, North London Gynaecological Cancer Network, University College London, UK.
- Alberto Ocaña: Director of Translational Cancer Research Unit, Albacete University Hospital, Spain.
- Sheila Piva: Consultant Oncologist, Department of Oncology, Fatebenefratelli e Oftalmico, Milan, Italy.
- Ayhan Ulusakarya: Consultant Physician, Medical Oncology, Paul Brousse Hospital, Paris, France.
At FirstWord, we stand behind our reports. If you're not completely satisfied, we’ll refund your money. Guaranteed.
Ongoing Benefits
The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord's guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.
Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.
- Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date.
- You will receive a copy of each Update Bulletin once available, which are issued each quarter after the publication date.
1 EXECUTIVE SUMMARY
2 RESEARCH OBJECTIVES
3 RESEARCH FOCUS
3.1 What are biosimilars?
3.2 How are biosimilars regulated?
3.3 What oncology products are biosimilar companies targeting?
4 THE RISING COST OF TREATING CANCER
4.1 Key insights summary
4.1.1 What’s the economic burden of cancer?
4.1.2 What’s driving the costs of cancer treatment?
4.1.3 What impact has increased spending on cancer therapies had?
4.1.4 Is there a solution to the increasing costs of cancer treatment?
4.1.5 Are biosimilars the answer?
5 ONCOLOGY BIOSIMILARS PIPELINE DYNAMICS
5.1 Key insights summary
5.1.1 Early investments in oncology biosimilars R&D focused on the development of biosimilar EPO-alfa and filgrastim
5.1.2 Amgen leads the race to gain approval for a bevacizumab biosimilar, with Pfizer and Boehringer Ingelheim 12-18 months behind
5.1.3 A rituximab biosimilar filing in Europe has now been made, but as the application only includes rheumatoid arthritis data, a rituximab biosimilar in oncology is still some years from being approved
5.1.4 The trastuzumab biosimilar race remains too close to call, with Amgen, Samsung Bioepsis, Pfizer and Mylan all capable of gaining approval within 6-12 months of each other
5.1.5 Pegfilgrastim biosimilars from Apotex and Sandoz are under review in the US, with Apotex having a 12 month head start
5.1.6 Other opportunities are focused on biosimilar versions of cetuximab and immunotherapy mAbs
6 AWARENESS, INFORMATION AND EDUCATION
6.1 Key insights summary
6.1.1 KOLs believe that the awareness of biosimilars amongst oncologists is rising due to the launch of Zarxio, but has some way to go to match levels of awareness in Europe
6.1.2 Oncologists have high levels of awareness of biosimilars in Europe, driven by product availability and positive clinical experience
6.1.3 High impact factor journals, regulatory agencies and medical associations are the best sources of information on biosimilars, but information is hard to find
6.1.4 KOLs argue that the biosimilar educational needs of physicians are not being met, but improvements have been seen over the last 12-18 months
7 TECHNICAL, REGULATORY AND CLINICAL
7.1 Key insights summary
7.1.1 KOLs believe that biosimilars need to be highly similar to the reference product, but acknowledge that, like originator biologics, slight differences will be unavoidable
7.1.2 Clinical endpoint selection, patient numbers per trial and limited clinical development all seen as key challenges for biosimilar developers
7.1.3 KOLs generally agree with biosimilar guidelines in relation to clinical study endpoints for oncology biosimilars, but the lack of survival data for oncology mAb biosimilars is concerning
7.1.4 KOLs don’t believe biosimilars will ever be approved without the need for clinical data, especially biosimilars of therapeutic mAbs
7.1.5 Recruiting patients for oncology biosimilar clinical trials seen by many KOLs as a key challenge in biosimilar development, with novel product development a leading cause
7.1.6 Biosimilars need to have distinguishable names compared to the originator product,
to support traceability and prevent prescribing and dispensing mistakes
7.1.7 Extrapolation of indications remains an area of significant uncertainty for KOLs, especially for biosimilars of therapeutic mAbs
8 CURRENT AND FUTURE UPTAKE OF BIOSIMILARS
8.1 Key insights summary
8.1.1 Historical rates of biosimilar adoption are below expectations due to a lack of knowledge and a ‘psychological attachment’ to the original brand
8.1.2 Lower acquisition costs, robust clinical data and aggressive payer tactics are singled out as key drivers of biosimilar adoption
8.1.3 Lack of clinical data, logistical issues and concerns that biosimilars could increase workloads for physicians are potential resistors to biosimilar adoption
8.1.4 KOLs believe that switching and pharmacy level substitution of biosimilars in the oncology setting need to be handled very carefully, with patient care and safety overriding all other considerations
9 THE FUTURE OF ANTIBODY BIOSIMILARS IN ONCOLOGY
9.1 Key insights summary
9.1.1 Access to therapeutic mAb biosimilars is unlikely to improve patient access in developed markets, and cost savings will depend on biosimilar and originator company pricing strategies
9.1.2 Uptake of bevacizumab biosimilars is likely to be limited to lung cancer patients in the first instance, as KOLs believe not having mCRC data will prevent broad adoption in this indication
9.1.3 Rituximab biosimilars are likely to be used most in the non-curative setting of follicular lymphoma as the risks of using them in more aggressive forms of lymphoma are too great
9.1.4 Trastuzumab biosimilars will need to come to market with robust data from the adjuvant setting for KOLs to be comfortable using them in patients with HER2 positive breast cancer
9.1.5 KOLs agree that biosimilars offer an opportunity to save money for the health service, and in some cases improve access, but biosimilars are some way off from being as well accepted as small molecule generics
10 APPENDIX
10.1 KOL biographies
10.1.1 KOLs from the US
10.1.2 KOLs from Europe
2 RESEARCH OBJECTIVES
3 RESEARCH FOCUS
3.1 What are biosimilars?
3.2 How are biosimilars regulated?
3.3 What oncology products are biosimilar companies targeting?
4 THE RISING COST OF TREATING CANCER
4.1 Key insights summary
4.1.1 What’s the economic burden of cancer?
4.1.2 What’s driving the costs of cancer treatment?
4.1.3 What impact has increased spending on cancer therapies had?
4.1.4 Is there a solution to the increasing costs of cancer treatment?
4.1.5 Are biosimilars the answer?
5 ONCOLOGY BIOSIMILARS PIPELINE DYNAMICS
5.1 Key insights summary
5.1.1 Early investments in oncology biosimilars R&D focused on the development of biosimilar EPO-alfa and filgrastim
5.1.2 Amgen leads the race to gain approval for a bevacizumab biosimilar, with Pfizer and Boehringer Ingelheim 12-18 months behind
5.1.3 A rituximab biosimilar filing in Europe has now been made, but as the application only includes rheumatoid arthritis data, a rituximab biosimilar in oncology is still some years from being approved
5.1.4 The trastuzumab biosimilar race remains too close to call, with Amgen, Samsung Bioepsis, Pfizer and Mylan all capable of gaining approval within 6-12 months of each other
5.1.5 Pegfilgrastim biosimilars from Apotex and Sandoz are under review in the US, with Apotex having a 12 month head start
5.1.6 Other opportunities are focused on biosimilar versions of cetuximab and immunotherapy mAbs
6 AWARENESS, INFORMATION AND EDUCATION
6.1 Key insights summary
6.1.1 KOLs believe that the awareness of biosimilars amongst oncologists is rising due to the launch of Zarxio, but has some way to go to match levels of awareness in Europe
6.1.2 Oncologists have high levels of awareness of biosimilars in Europe, driven by product availability and positive clinical experience
6.1.3 High impact factor journals, regulatory agencies and medical associations are the best sources of information on biosimilars, but information is hard to find
6.1.4 KOLs argue that the biosimilar educational needs of physicians are not being met, but improvements have been seen over the last 12-18 months
7 TECHNICAL, REGULATORY AND CLINICAL
7.1 Key insights summary
7.1.1 KOLs believe that biosimilars need to be highly similar to the reference product, but acknowledge that, like originator biologics, slight differences will be unavoidable
7.1.2 Clinical endpoint selection, patient numbers per trial and limited clinical development all seen as key challenges for biosimilar developers
7.1.3 KOLs generally agree with biosimilar guidelines in relation to clinical study endpoints for oncology biosimilars, but the lack of survival data for oncology mAb biosimilars is concerning
7.1.4 KOLs don’t believe biosimilars will ever be approved without the need for clinical data, especially biosimilars of therapeutic mAbs
7.1.5 Recruiting patients for oncology biosimilar clinical trials seen by many KOLs as a key challenge in biosimilar development, with novel product development a leading cause
7.1.6 Biosimilars need to have distinguishable names compared to the originator product,
to support traceability and prevent prescribing and dispensing mistakes
7.1.7 Extrapolation of indications remains an area of significant uncertainty for KOLs, especially for biosimilars of therapeutic mAbs
8 CURRENT AND FUTURE UPTAKE OF BIOSIMILARS
8.1 Key insights summary
8.1.1 Historical rates of biosimilar adoption are below expectations due to a lack of knowledge and a ‘psychological attachment’ to the original brand
8.1.2 Lower acquisition costs, robust clinical data and aggressive payer tactics are singled out as key drivers of biosimilar adoption
8.1.3 Lack of clinical data, logistical issues and concerns that biosimilars could increase workloads for physicians are potential resistors to biosimilar adoption
8.1.4 KOLs believe that switching and pharmacy level substitution of biosimilars in the oncology setting need to be handled very carefully, with patient care and safety overriding all other considerations
9 THE FUTURE OF ANTIBODY BIOSIMILARS IN ONCOLOGY
9.1 Key insights summary
9.1.1 Access to therapeutic mAb biosimilars is unlikely to improve patient access in developed markets, and cost savings will depend on biosimilar and originator company pricing strategies
9.1.2 Uptake of bevacizumab biosimilars is likely to be limited to lung cancer patients in the first instance, as KOLs believe not having mCRC data will prevent broad adoption in this indication
9.1.3 Rituximab biosimilars are likely to be used most in the non-curative setting of follicular lymphoma as the risks of using them in more aggressive forms of lymphoma are too great
9.1.4 Trastuzumab biosimilars will need to come to market with robust data from the adjuvant setting for KOLs to be comfortable using them in patients with HER2 positive breast cancer
9.1.5 KOLs agree that biosimilars offer an opportunity to save money for the health service, and in some cases improve access, but biosimilars are some way off from being as well accepted as small molecule generics
10 APPENDIX
10.1 KOL biographies
10.1.1 KOLs from the US
10.1.2 KOLs from Europe
