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?

Report Overview

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.

Key features

  • 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

Key Benefits

  • 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

Expert Views

  • 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 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.

Biobetters: Major Players and Market Prospects (2nd edition) costs $495 a copy. Click here to order.

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Publication date:
 September 2011
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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.”
Jesús 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

Content Highlights

  • 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