Biobetters: Major Players and Market Prospects (2nd edition)

Date: September 22, 2011
Pages: 48
Price:
US$ 495.00
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Publisher: FirstWord
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: BDCF5FB71B1EN
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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
  • 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
Purchase Reasons
  • 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
Key Questions Asked
  • 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?
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
Key quotes

“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

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