What Is the Value of Real-World Evidence for Biosimilars?


Moderator: Delphine Courmier, PhD, MBA, Organon, Jersey City, NJ, USA
Panelists: Steven Simoens, PhD, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, VBR, Belgium; Phani Veeranki, MD, DrPH, HEOR, Optum Life Sciences, CYPRESS, TX, USA; Tijana Fazlagic, MSc, PharmD, BC Ministry of Health, Victoria, BC, Canada

ISSUE: What is the value of Real-World Evidence for Biosimilars?


Biosimilars have been available in many countries for several years and are increasingly accepted as therapeutic options allowing sustainable and improved patient access to essential medicines. However, uptake and acceptance still vary, and the US is lagging behind other countries, although the launch of adalimumab biosimilars in 2023 is expected to be an inflection point for biosimilars adoption. Robust regulatory processes, notably by the FDA and EMA, allow to address key questions on the quality, safety and efficacy of biosimilars. However, RWE is utilized, notably by payers, healthcare providers and physicians to resolve remaining clinical uncertainties and utilization questions.

The panel will explore situations where the totality of evidence, supporting regulatory approval of biosimilars, is sufficient to support confidence and adoption of biosimilars, as well as case studies in which additional questions raised by biosimilar introduction – such as real-life patient adherence and switching – can be addressed by RWE. We will discuss how to ensure robust RWE data collection, learning from the experience of the RWE on the nocebo effect with TNF-alpha inhibitor biosimilars, which delayed biosimilar adoption. The panel will also discuss the need for pragmatic data collection that can address operational questions related to the formulary listing of biosimilars – benefit of multi-dose vials for compounding, bacteriostatic diluent increasing fridge life of reconstituted vial and reducing cytotoxic waste included in pack, biosimilars addressing underdosing of filgrastim in real-life clinical practice – as well as additional biosimilar benefits linked to lower patient copay and improved adherence to chronic therapies. To conclude, the panel will recommend best practices around designing RWE studies for critical insights into biosimilar utilization and outcomes beyond clinical trials, thus addressing some of the lingering clinical barriers to biosimilars adoption.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA




Real World Data & Information Systems

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