PURPOSE:  The U.S. Food and Drug Administration approved its first biosimilar in 2015 launching the U.S. into the biosimilar market. The U.S. healthcare system presents different challenges for the uptake of biosimilars into the marketplace than what Europe has experienced to date. This workshop will focus on understanding the current biosimilars landscape and considerations for evidence generation. Workshop participants will become familiar with recent developments in biosimilars, market uptake and coverage considerations, approaches to biosimilars real-world evidence generation, and opportunities to use existing data sources. DESCRIPTION: Participants will obtain an overview of biosimilars and considerations for evidence generation. The workshop will review the current biosimilar environment, considerations for market uptake and evidence needs, how to evaluate biosimilars in the real-world, and what role existing data sources and consortiums, such as Sentinel and PCORnet, have in generating biosimilars evidence. Dr. Jaclyn Bosco will review the current biosimilars situation, summarize real-world evidence from the European experience, and considerations for real-world evidence generation of biosimilars including methodologic approaches to study design and data acquisition considerations. Dr. Gregory Daniel will discuss post-market safety requirements, U.S. payer coverage decisions, and the impact of naming and coding considerations on market uptake. Dr. Catherine Panozzo will discuss lessons learned from the Mini-Sentinel and activities initiated by the Biologics and Biosimilars Collective Intelligence Consortium, and Dr. Rachel Fleurence will assess the practicality and potential usefulness of PCORnet to generate real-world biosimilars evidence. Audience attendees will be encouraged to share their biosimilars experience and perspectives during the workshop. This interactive and informative workshop will be valuable to researchers, providers, industry representatives who are interested in generating safety and effectiveness evidence on biosimilars as well as those interested in understanding recent developments in and considerations for biosimilars.