Defending Against Biosimilars: Originator strategies

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Battle of the biologics: How to survive

The onward march of biologics has shaped a brave new world for drug manufacturers with conflicting rules and regulations and an eclectic mix of individual players to contend with.  Biosimilars are more pervasive than ever; complex and hard-fought patent disputes are commonplace; regulators are struggling to keep pace with change. Against this chaotic backdrop, how should biologics manufacturers protect and grow their business? 

Report Overview

Based on in-depth interviews with eight biologics experts from leading biotechnology, consulting, marketing and healthcare-associated companies, Defending Against Biosimilars: Strategies To Retain Market Share provides a clear path forward.  Taking perspectives from both the US and EU, this report delves into the threats facing the biologics marketplace and identifies what must happen for biologics companies to not only survive, but effectively compete and ultimately thrive.

Report Features

• Assessment of the key threats including the effect of approval and regulatory differences within the biologics space as well as the impact of payer pressure on the market. 
• Insight into how biologic originators can justify the cost of products. Are value added services a useful weapon? Is more effort to educate payers and physicians on biologics and biosimilars needed? 
• New ideas on the defence tactics already used by originator biologic developers to retain market share, protect pricing and respond to market changes. 
• Step-by-step guides on how to conduct a robust risk assessment and how to implement a tailored biologic defence strategy.
• Potential solutions an originator or biosimilar company can apply to counter threats impacting their business. 

Key Benefits

• Deepen understanding of the biologic marketplace: Explore the key differences in developing and marketing biologics versus traditional drugs. What approval processes are in place? How does the landscape differ for biosimilars?
• Get up to speed on this evolving market: Read about the current positon for biologics, biosimilars and “bio-betters” in the US and EU – plus the key trends predicted by the experts.
• Understand the specific threats facing your biologic business: What should biologics manufacturers focus on to mitigate risk?  Explore further the unique perspective of biosimilar manufacturers.
• Clarify your marketing strategy: See where to focus effort and resources for optimum impact and gain clarity on how the market is likely to evolve.
• Gain the focus needed to evolve an action plan: Discover how to clearly assess the risks facing your biologic business and understand the key elements required to conduct an effective defence strategy. 

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Key Questions Answered By This Report

• What are the main threats facing biologics developers in the current market? And what are the distinct issues for originators versus biosimilars?
• Is the current regulatory climate a help or a hindrance? Or both? How does the experience of originators and biosimilar companies differ?
• How are market dynamics affected by patent law and the resulting disputes underway following significant biosimilar developments? 
• What can biologics manufacturers do to minimise risk and maximise their market penetration?
• What does the future hold for biologics? Which companies do experts believe will be most vulnerable to intense competition?

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Why are biologics such an urgent priority for pharma?

The biologics debate has got fiercer in recent months and interested onlookers could be forgiven for thinking that some drug manufacturers are investing more in patent protection, litigation and lawyers than they are in development. Take away the concerns and rhetoric and there is no disputing the fact that biologics present exciting opportunities for patients and physicians, as well as for drug manufacturers of all sizes and specialisms. A tightening of regulatory standards around several aspects of the biological-biosimilar divide will ultimately provide some sense of order, but gaining consensus is slow and whilst the discussions are underway, the world continues to turn. In this current state of flux, some biologics players will emerge as winners. The question is: which ones?

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Expert Views

• Alexander Yule: Principal, Alexander Yule Consulting
• Rakesh Dixit: Vice President of R&D, MedImmune
• Sandy Eisen: Chief Medical Officer, Frontline Pharma Consulting
• Stephen Murby: Alliance for Safe Biologic Medicines
• Anonymous: Global Commercial Director, Roche
• Anonymous: Previous Marketing Director at a large pharmaceutical company
• Anonymous: Head of Biologicals at multi-national biosimilar company
• Anonymous: Director of Medical Affairs – Biosimilars at large pharmaceutical company

4 Key Quotes

“As hard as it may be to accept for some originators, there is a place for biosimilars. However, the regulatory/payer world needs to ensure a level playing field. When a biosimilar comes to market, one should let the originator compete on equal terms.” 
Previous Marketing Director of a large pharmaceutical company

“You can't just sit back and say, ‘well my drug is better,’ because there's absolutely nothing to show that it is. That part of it is gone. So, it's really just down to saying, ‘we accept there are cheaper drugs in the marketplace.’ 
Alexander Yule, Principal, Alexander Yule Consulting

“We'll see how the market shapes up, but I think the coming few years will be interesting to watch what risks big companies are taking and how much revenue they are generating using the biosimilars.”
Rakesh Dixit, Vice President of R&D, MedImmune

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Who Would Benefit from This Report?

• Senior leadership teams concerned about the threats facing original biologics and biosimilars
• Marketing departments, territorial marketing specialists and global marketing strategists
• Market access teams dealing with formulary decision-makers for biologics
• Medical science liaisons (MSLs) dealing with questions from physicians about biologics
• KAM professionals looking at retaining or engaging accounts where biologics feature
• Payer liaison departments facing increasing pressure on prices

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Content Highlights

• Executive summary
• Biological drugs overview
• What is a biological drug?
• How are biological products different from traditional pharmaceuticals?
• How are biologic therapies approved?
• Special considerations for biosimilars
• Threats to the biologic marketplace
• Is regulatory oversight hindering biological drug development?
• Do existing patent protection laws represent a threat to the biologic market?
• Do payers represent a barrier to biologics uptake?
• For which treatment area are biosimilars expected to pose the greatest threat to originators?
• The unique threats for biosimilar developers
  
  • Is there a significant difference between threats for biological makers and biosimilar companies?
  • Are regulators more critical of biosimilar developers than originators?
  • Lack of interchangeability and indication extrapolation guidelines sends a mixed message about the quality of biosimilars
  • Do newer biosimilar market entrants face bias from stakeholders?
  • Could biosimilars from emerging markets pose a threat in developed markets?
  • Which stakeholders represent a threat to biosimilars?
  • Are originator companies preying on insecurities about the ‘sameness’ of biosimilars?
• Defence tactics
• Patent extensions afford market protection to originator companies
• Both originator and biosimilar companies explore strategies to offset cost savings of biosimilars
• Originator companies focus on developing bio-betters to retain market share
• Enhanced education could be key to achieving – and retaining – biological drug buy in
• The ability to tailor your marketing strategy or respond to change in the market place could be key to survival
• How to conduct an assessment of your company’s risk
• How to implement a biologics defence strategy
• The future of biosimilar defence strategies
• Companies that are too diversified, unwilling to partner most vulnerable to market competition, experts suggest
• Future areas of focus should include increased communication with stakeholders
• Future strategies for retaining market share vary by disease area, market

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