Real-World Evidence Requirements for Biosimilar Products

Observational Studies for Biosimilars | UBC

Real-World Evidence Requirements for Biosimilar Products

Biosimilar agents are similar but non-identical versions of existing biological drugs and may be authorized for use once the patent on the reference product has expired. Based on a recent market forecast of IMS, biosimilars are forecasted to deliver total savings of as much as $110 billion to health systems across Europe and the U.S. through 2020. The UBC team undertook a literature review to identify and describe characteristics of observational studies involving biosimilar agents. The results were presented in a poster at ISPOR titled “Observational Studies Evaluating Biosimilar Agents: A Focused Literature Review”.

The Embase search engine was used to identify any observational study involving biosimilar agents during the period April 1, 1990 to June 10, 2015. Key data were abstracted, including:

  • Country
  • Year
  • Type of study
  • Therapeutic area
  • Biosimilar agent(s)
  • Reference product
  • Follow-up time
  • Study outcomes: safety and effectiveness outcomes and whether these were comparable or not to the reference product, health resource utilization (HRU), quality of life (QoL), other outcomes
  • Whether the study was regulator-mandated

Almost all studies were regulator-mandated and assessed safety and effectiveness outcomes. The study infrastructures were often leveraged by including other outcomes (HRU, patterns of care, and QoL). As the number of biosimilar agents approved by regulators in the US and EU increases, the demand for observational studies assessing real-world outcomes may grow.

Contact us to discuss how our Value Demonstration team can assist with the real-world evidence needs of your biosimilar.