Biosimilars: The Importance of Real-World Evidence (2019)

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Publication Date:
June 2019
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Are you generating the right RWE to influence the right stakeholders?

As the biosimilar sector continues to evolve and experience of their use deepens, what role should real-world evidence (RWE) now take in stakeholder communications and education? Focusing RWE that supports health decisions is vital so which stakeholders should be the target of your RWE strategy, what evidence do they want and, more importantly, what data sources will deliver?

In this new June 2019 report, Biosimilars: The Importance of Real-World Evidence, experts from companies such as Sandoz, Avalere and Biogen reveal their insights on the practical issues and challenges of cost-effectively generating powerful RWE that really drives physician understanding, increases patient confidence and positively influences wider stakeholders.

Biosimilar experts tackle key questions

  • What role does RWE play in determining the adoption of biosimilars, for both new and existing patients?
  • What types of real-world data/studies are required to present a convincing value proposition for biosimilars and do they differ depending on the type of stakeholder being targeted?
  • What are the challenges in acquiring real-world evidence for biosimilars and how does this vary by jurisdiction?
  • How does RWE change physicians' levels of confidence in biosimilar drugs and can it be used to support HCPs in making decisions that facilitate better outcomes for patients?
  • What are the benefits and challenges for biosimilar developers in partnering with patient advocacy groups at an early stage?
  • How should biosimilar companies approach generating real-world evidence and what role does this data play in payer negotiations?

What our experts say…

"I think normalising everybody's understandings about biosimilars compared to originators is important, because there's often this suggestion made that there's no unmet medical need for a biosimilar, because you've already got the originator. But is that value based on the product being accessible and affordable by everybody who can benefit? What would be useful for us, particularly in the US, is that RWE is appropriately documented in an accessible way, particularly for physicians, but also payers to see."
Gillian Woollett, Senior Vice President Avalere Health

"I think the first thing that I would do as a biosimilar company is make sure that you actually need it [real-world evidence] and make sure that you educate the different stakeholders with whom you are dealing as to the robustness of the biosimilar pathway. It is important to make sure that their cry for more data and more evidence is not simply a reflection of a lack of understanding of the biosimilar pathway. That's because, if you're uncomfortable with something, then the easiest thing to say is, 'I need more data.' The more data we ask for, the more we delay the adoption of biosimilars, the more we're going to pay high prices for drugs where the same benefits could be attained at a lower cost."
Head of Safety (Biosimilars), Multinational pharmaceutical company

"The real question a patient is going to have is – why are you switching? How does the physician answer that question? Because at the end of the day, the only reason to use a biosimilar is cost. So, you just want to assure patients with real-world evidence using that term that you're changing their therapy and they're going to be okay."
Steven Lehrer, Managing Director SBLehrer LLC

"Challenges are related to lack of understanding regarding comparability. It is about finding the right balance between the need for additional data while keeping the development programmes and cost of biosimilars at an acceptable level. I think a key area is the creation of additional information to inform decision-makers. Improving healthcare decision-making needs to be rewarded as well, and not just the price. If that is not valued, then it's going to be quite difficult for the right amount of evidence to be generated across different markets. So, it very much depends on the healthcare decision you would like to inform."
Global Head, Commercial Biopharmaceuticals Sandoz

What to expect

  • A detailed report revealing US and European expert insights into the key impact areas for biosimilar RWE as the sector evolves.
  • An examination of 16 key issues which biosimilar and biologic developers need to understand and respond to.
  • 27 targeted questions put to industry experts.
  • Their perceptive responses that provide 38 insights supported by 152 directly quoted comments.

Expert contributors

This report harnesses the critical insights of experienced US and European payers. In some cases their identities have been kept anonymous to ensure free and frank expression of views.

  • Dr Mourad Farouk Rezk, Global head of medical (Biosimilars) at Biogen brings more than 20 years of experience in the pharmaceutical industry, holding a number of leadership roles in medical affairs, R&D and marketing. Before joining Biogen, Dr Rezk was with Amgen for nearly eight years as an international medical lead for nephrology innovator biologics and the company's EU biosimilars taskforce.
  • Gillian Woollett, Senior Vice President, Avalere Health has a demonstrated history of working across the health policy sector. She has strong professional skills in all aspects of biotechnology, biologics and biosimilars, as well as regulatory strategy for medicinal products across the highly regulated markets.
  • Michael Muenzberg, Consultant, Biosimilar consultancy is licensed as Doctor of Nuclear Medicine and has more than 20 years' experience in pharmaceutical industry with an emphasis on Biosimilars, working as local as well as global Medical Manager/Director for Serono, Novartis, Amgen, Roche, Sandoz International Biopharmaceuticals and Merck Serono Biosimilars. His recent position was Medical Director Biosimilars EU at Amgen Europe, responsible for the launch of pipeline Biosimilars in Oncology and Inflammatory Diseases.
  • Steven Lehrer, Managing Director, SBLehrer LLC brings over 30 years of experience starting, growing, and running life science-based businesses focused on commercializing new technology and expanding businesses globally. He has extensive experience in pharmaceutical, biopharmaceutical and biosimilar R&D, regulatory, operations and commercialisation and has worked in companies including Cipla Biotec, Monsanto/Searle, Glycominds and Adamas Pharma.
  • Erik Skullerud, Owner & Managing Partner, Element Consulting GmbH. He brings 25 years of global pharma/biotech experience and extensive business management experience from different therapeutic areas and geographies in companies such as Amgen and Bayer. He has been working as an independent advisor/consultant since 2017.
  • Anonymous, Global Head, Commercial Biopharmaceuticals, Sandoz with more than 15 years of global pharmaceutical and generics industry experience. He has held several roles responsible for business-to-business commercialisation market access, pricing, public affairs and health economics.
  • Anonymous, Head of Safety (Biosimilars), multinational pharmaceutical company with experience leading global clinical development teams and has served as global medical brand director. He has also led clinical teams for in-licensing due-diligence and managed clinical-trial reviews, first-in-man transitions and product safety assessments.
  • Anonymous, Head of Medical Affairs, Biosimilars and Generics (Europe) is a highly qualified medical manager, with both a medical and commercial background. He has long experience in pharma industry in corporate environment on a local and regional level, achievements in launch preparation, clearing legal pathway for biosimilar launch, medical communication for marketed biologics and developing medical affairs strategy for biosimilars.

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