Product Code: 400200055
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
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?
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'
- A comprehensive overview of the nascent biobetters market and where it is
- 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
Key Questions Asked
- How do second generation biologics vary from biobetters proper?
- Will biobetters go through an abbreviated or full new drug approval
- Who will be the pioneers of the biobetter industry and what is spurring
- How is interest by third-party manufacturers affecting the development of
- How is the risk of immunogenicity affecting the case for branded biotech?
- What areas of improvement exist for creating improved biobetters?
Who Should Read This Report
- 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
- Dr. Sandy Eisnen, formerly Chief Medical Officer at Teva
- Dr. Jesús Zurdo, Head of Innovation at Lonza Biologics
- Dr. David Szymkowski, Senior Director of Biotherapeutics at Xencor
- 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.
Table of Contents
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
- 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