Biobetters: Major Players and Market Prospects (2nd edition)
Marketing gimmick or natural evolution?
For some, biobetters—drugs similar but superior to the branded reference product—are little more than the natural outcome of a drug’s life-cycle management strategy.
Even so, interest in biobetters is increasing, since they can and will command higher prices while providing a significant improvement to the reference drug. At the forefront of those turning to biobetters are branded pharma, biotech and large generic companies who have already established themselves in the biosimilars industry. But will the emerging biobetter industry prove to be more lucrative than has been the case for biosimilars?
Scope
In Biobetters: Major Players and Market Prospects (2nd edition), FirstWord describes the biobetters market and how interest has mounted in what is still a very young market. The report reviews the role biosimilars have played, presents the rationale behind biobetters and how interest is is stirring in their development. In addition, the report concisely outlines how companies are evolving biobetters, the areas of greatest potential and reviews the ‘Achilles Heel’ of immunogenicity. Based on frontline expert interviews, the report addresses the question of approval pathways, who the major players are and, perhaps most importantly, offers a compelling picture of biobetters’ future prospects.
Highlights
“I think it was just natural to start reminding people that rather than developing a biosimilar and trying to capture a small fraction of a much larger, more established market, take it one better and develop a biologic that has superior properties.”
– David Szymkowski, Senior Director, Biotherapeutics, Xencor Inc
“Anything that includes a modification of an innovator molecule is, by definition, a biobetter. However, it has to have a real therapeutic benefit to the patient. It has to have a significant advantage over its predecessor to be really classified as a biobetter.”
– Jesus Zurdo, Head of Innovation, Lonza Biologics
“Some products that are described as biobetters may be indistinguishable from a completely novel product. The concept of a specific abbreviated pathway intended for biobetters does not make sense to regulators.”
– Dr Sandy Eisnen, former Chief Medical Officer, Teva
Expert Views
For some, biobetters—drugs similar but superior to the branded reference product—are little more than the natural outcome of a drug’s life-cycle management strategy.
Even so, interest in biobetters is increasing, since they can and will command higher prices while providing a significant improvement to the reference drug. At the forefront of those turning to biobetters are branded pharma, biotech and large generic companies who have already established themselves in the biosimilars industry. But will the emerging biobetter industry prove to be more lucrative than has been the case for biosimilars?
Scope
In Biobetters: Major Players and Market Prospects (2nd edition), FirstWord describes the biobetters market and how interest has mounted in what is still a very young market. The report reviews the role biosimilars have played, presents the rationale behind biobetters and how interest is is stirring in their development. In addition, the report concisely outlines how companies are evolving biobetters, the areas of greatest potential and reviews the ‘Achilles Heel’ of immunogenicity. Based on frontline expert interviews, the report addresses the question of approval pathways, who the major players are and, perhaps most importantly, offers a compelling picture of biobetters’ future prospects.
Highlights
- A comprehensive overview of the nascent biobetters market and where it is going
- An outline of what biobetters are, how they are being developed and what their likely targets are
- A discussion of the regulatory landscape
- An insight into the biobetters manufacturers of tomorrow
- An overview of optimal strategies for success
- Access to top expert opinion and insights
- Compelling overview of the biobetters industry
- Frontline reporting on how it’s evolving and who will be the industry leaders
- How do second generation biologics vary from biobetters proper?
- Will biobetters go through an abbreviated or full new drug approval pathway?
- Who will be the pioneers of the biobetter industry and what is spurring their success?
- How is interest by third-party manufacturers affecting the development of superior biosimilars?
- How is the risk of immunogenicity affecting the case for branded biotech?
- What areas of improvement exist for creating improved biobetters?
- Licensing and Business Development Managers
- Sales and Marketing Executives
- Strategic Management
- Medical Affairs
- Regulatory Affairs
- New Product Development Managers
- Marketing Research
- Preclinical and Clinical Development Executives
- Intellectual Property Executives
- Pricing and Reimbursement Heads
- Market Access Executives
“I think it was just natural to start reminding people that rather than developing a biosimilar and trying to capture a small fraction of a much larger, more established market, take it one better and develop a biologic that has superior properties.”
– David Szymkowski, Senior Director, Biotherapeutics, Xencor Inc
“Anything that includes a modification of an innovator molecule is, by definition, a biobetter. However, it has to have a real therapeutic benefit to the patient. It has to have a significant advantage over its predecessor to be really classified as a biobetter.”
– Jesus Zurdo, Head of Innovation, Lonza Biologics
“Some products that are described as biobetters may be indistinguishable from a completely novel product. The concept of a specific abbreviated pathway intended for biobetters does not make sense to regulators.”
– Dr Sandy Eisnen, former Chief Medical Officer, Teva
Expert Views
- Dr Sandy Eisnen, formerly Chief Medical Officer at Teva
- Dr Jesus Zurdo, Head of Innovation at Lonza Biologics
- Dr David Szymkowski, Senior Director of Biotherapeutics at Xencor Inc.
- Ronald A. Rader, President of Biotechnology Information Institute
- In addition to an Indian Biotech executive, an executive at a major US generic company, a Development Director of a specialist Biotech company, and a Senior Manager at a biotech manufacturer.
EXECUTIVE SUMMARY
BRANDS, BIOSIMILARS, AND BIOBETTERS
The market for biological medicines
The emergence of biosimilars as a cost-saving tool
COMPARISON OF INTERNATIONAL LIST PRICES FOR MABTHERA/RITUXAN
The rationale for biobetters
BIOBETTERS – NEW NAME FOR AN OLD DRUG?
Small molecule parallels
‘Biobetters’ already on the market
How much better are Biobetters?
Putting the ‘Better’ into Biobetter
Extent and type of changes
Half-life extension and pegylation
Glyco-engineering and cell production systems
Emerging methods
Prolonging half-life via deuteration
Modifying formulation
Biobetter targets – possibilities abound
Interferons, growth hormones, and blood factors: good biobetter candidates
Monoclonal antibodies could be improved upon
Oncology could be a growth area for biobetters
Immunogenicity – the Achilles Heel of Biobetters?
Originators could use immunogenicity as a defensive shield
Prediction is a risky game
Clinical trials as the current gold-standard for immunogenicity testing
Biobetters – the route to market
The full approval pathway beckons for biobetters
Data package requirements could vary
Clinical trial requirements likely to be biobetter specific
The bar for regulatory approval could be higher
…but the risks are lower
Patent complications
Biobetter pricing and reimbursement
Biobetter benefit must justify price
Cost of treatment versus unit pricing
A crowded market for biobetters?
Opening up new markets
Market access strategies
The Biobetters Race – Major Players
Multinational interest in biobetters – the usual suspects?
The biobetter aspirations of larger generics companies
Small biotech – a key biobetter player
Success through collaboration
The Asian factor
Regulatory pressures could resist incursion of Asian players
Manufacturing costs will have minimal impact on biobetter success
Stakeholder distrust in the short-term could restrict Asian biobetter success
CONCLUSION
ACKNOWLEDGEMENTS
BRANDS, BIOSIMILARS, AND BIOBETTERS
The market for biological medicines
The emergence of biosimilars as a cost-saving tool
COMPARISON OF INTERNATIONAL LIST PRICES FOR MABTHERA/RITUXAN
The rationale for biobetters
BIOBETTERS – NEW NAME FOR AN OLD DRUG?
Small molecule parallels
‘Biobetters’ already on the market
How much better are Biobetters?
Putting the ‘Better’ into Biobetter
Extent and type of changes
Half-life extension and pegylation
Glyco-engineering and cell production systems
Emerging methods
Prolonging half-life via deuteration
Modifying formulation
Biobetter targets – possibilities abound
Interferons, growth hormones, and blood factors: good biobetter candidates
Monoclonal antibodies could be improved upon
Oncology could be a growth area for biobetters
Immunogenicity – the Achilles Heel of Biobetters?
Originators could use immunogenicity as a defensive shield
Prediction is a risky game
Clinical trials as the current gold-standard for immunogenicity testing
Biobetters – the route to market
The full approval pathway beckons for biobetters
Data package requirements could vary
Clinical trial requirements likely to be biobetter specific
The bar for regulatory approval could be higher
…but the risks are lower
Patent complications
Biobetter pricing and reimbursement
Biobetter benefit must justify price
Cost of treatment versus unit pricing
A crowded market for biobetters?
Opening up new markets
Market access strategies
The Biobetters Race – Major Players
Multinational interest in biobetters – the usual suspects?
The biobetter aspirations of larger generics companies
Small biotech – a key biobetter player
Success through collaboration
The Asian factor
Regulatory pressures could resist incursion of Asian players
Manufacturing costs will have minimal impact on biobetter success
Stakeholder distrust in the short-term could restrict Asian biobetter success
CONCLUSION
ACKNOWLEDGEMENTS
