Commercialisation of Biosimilars: Current Best Practice and Future Trends

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Publication Date:
December 2018
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The key to commercial success for biosimilars? Find out what the experts say

The biosimilars market is in a state of flux as key players in the US and Europe actively seek to improve perceptions, shape the market, and establish their individual positions for competitive advantage. Understanding the nuances of biosimilar market access is an important way to realise healthcare savings and protect ROI – especially as experts confirm that a one-dimensional price driven approach will not stand up to the rigours of this high stakes market.

This report will bring you up-to-speed on activity over the last 12 months and provide insight and inspiration on how to craft your biosimilars market strategy. We spoke at length to 10 leading players in this specialist field to get their views on the key issues.

  • What's changing? Find out the current state of evolving biosimilar markets in Europe and the US, including regulatory changes and major influences – and discover what the experts expect to happen next.
  • What should your commercial strategy include? What key stages pre- and post-approval should be adhered to? Which activities should be undertaken at various points in the lifecycle? Just how do you plan to differentiate?
  • Who's needed, when and why? Who should drive commercial strategy? What role should clinical, regulatory and medical teams play? How important are steering committees? Who else could you bring in?
  • How to get the global/local balance right: What level of strategy customisation is recommended to accommodate local requirements? How can global and local affiliate teams work better together?
  • Tactics and success factors: Gain practical guidance on what works and what doesn't. And review case studies for Zarxio, Inflectra and Truxima to find out what went well and what could have been done better.

What to expect from this report

Yes, the process is infinitely complex – but it's not enough to simply 'copy and produce'. To achieve commercial success and ROI, a carefully crafted strategy must be planned early on in the process and then refined to adapt to an evolving market. This report raises the issues that should be front of mind: differentiation, production quality, capacity, delivery and more. Use it to create your commercial strategy specification and plan tactics to get ahead.

How did we do it?

  • We identified 20 current issues affecting the commercialisation of biosimilars today
  • We explored these via 35 targeted questions put to 10 experts in the US and EU
  • We used all of this to uncover 45 new insights
  • Insights are supported by 198 directly quoted comments, 62 sources and 3 case studies

Example insight included in Commercialisation of Biosimilars: Current Best Practice and Future Trends

Ensuring a robust supply chain to deliver quality biosimilars that generate positive returns on investment (ROI) is critical for a successful commercialisation process. Experts clarify that a major deciding factor for the commercial success of biosimilars is confidence in quality of the product and timely supply of the drug. Additional factors for success include differentiating the biosimilar through supportive patient access programmes or a more convenient device. Experts warn of excessive investment in generating clinical data in support of the biosimilar, as the final success of the product will depend on ROI.

Example quote included in Commercialisation of Biosimilars: Current Best Practice and Future Trends

"What new biosimilar companies and established biosimilar companies need to make sure is that payers recognise the need to make biosimilar markets sustainable. Healthcare systems will want quality companies that have a long history in producing biologics and biosimilars and payers to have continued interested in providing biosimilars. If you're left with people without that experience, one day biosimilars cannot be supplied to the market and then you have destroyed the sustainability of the biosimilar market."

The expert panel for Commercialisation of Biosimilars: Current Best Practice and Future Trends

  • Rodeina Challand, Executive Director, WorldWide Clinical Trials
  • Steven Lehrer, Managing Director, SBLehrer LLC
  • Adam Levysohn, Head of Global Market Access, Biogen Biosimilars Business Unit
  • Michael Muenzberg, consultant for biosimilars, biosimilar consultancy
  • Erik Skullerud, Owner & Managing Partner, Element Consulting GmbH
  • Florian Turk, Global Head, Commercial Biopharmaceuticals, Sandoz (Novartis)
  • Mateja Urlep, CEO, TikhePharma
  • Gillian Woollett, Senior Vice President, Avalere Health
  • Head of Department, Gedeon Richter (Anonymous)
  • Head of Medical Affairs, Biosimilars and Generics (Europe) (Anonymous)

Why buy now?

Whether you're concerned with the embryonic US market or the intensely competitive European market, a successful commercial strategy has to be built on the latest knowledge. This report ensures yours is up-to-date, whether that's awareness of the encouraging new recommendations from the FDA, or current trends in biosimilar education and promotion in Europe. Plus new ideas to feed into your biosimilar commercial strategy can only be a positive step forward.

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