Biosimilars offer the potential to bring life-savings cost-effective drugs to patients around the world, and significant financial benefits to the developers who bring them to market. At the annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) meeting in May, I’ll be joining a team of experts to discuss current developments and real-world evidence generation of biosimilars and some of the challenges that can impact their approval and market success.

Biosimilars are biological products that are designed to be highly similar to an already approved biological product, and have been shown to have no clinically meaningful differences from the reference. They can consist of large molecules, such as human insulin or erythropoietin, or more complex large molecules such as monoclonal antibodies. With patents of branded biologics continuing to expire, the biosimilars industry holds incredible growth potential – industry analysts predict it will be worth US$35 billion by 2020, up from US$1.3 billion in 2013.

The U.S. is just now entering the biosimilars marketplace. While the U.S. Food and Drug Administration (FDA) approved its first biosimilar in 2015, the EU has been approving biosimilars for a decade. Since establishing a legal framework for approval in 2005, the European Medicines Agency (EMA) has approved 20 biosimilars under the guidelines, corresponding to seven different reference biologics to date.

In the workshop at ISPOR, on May 23 at 5 pm, participants will gain a better understanding of the biosimilars landscape and how to generate real-world evidence to demonstrate post approval safety and effectiveness. I will review the current biosimilars situation and summarize the experience in the EU for real-world evidence generation to support biosimilars, including methodologic approaches to study design and data acquisition considerations.

My fellow speakers include:

  • Dr. Gregory Daniel, Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy at Duke University, will discuss post-market safety requirements, including the kinds of real world study data that regulators and payers will require to support approval and reimbursement, and the impact of naming and coding considerations on market uptake.
  • Dr. Catherine Panozzo, Instructor in the Department of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School, will share lessons learned from the Mini-Sentinel -- a pilot project sponsored by the FDA to create an active surveillance system that can monitor the safety of FDA-regulated medical products. She will also explore work being done through the Biologics and Biosimilars Collective Intelligence Consortium, a public service initiative that will draw on large sets of de-identified pharmacy and medical data to provide unbiased scientific information on the safety and effectiveness of marketed biosimilars and their corresponding novel biologics.
  • Dr. Rachel Fleurence,  Program Director of the CER Methods and Infrastructure Program at the Patient-Centered Outcomes Research Institute (PCORI), will assess the practicality and potential usefulness of PCORnet to generate real-world biosimilars evidence.

Biosimilars may offer huge potential for increased affordability and accessibility of life-altering medicines to patients who need them, but only if developers can demonstrate safety and effectiveness in a way that is meaningful for regulators, payers and providers. This interactive and informative workshop will be valuable to researchers, providers, industry representatives who are interested in generating this evidence for biosimilars as well as those interested in understanding recent developments in and considerations in this space.

Topics in this blog post: Biologics, Biosimilars, Data Integration, Evidence, Registries