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Managed Care Research in Action

(R2) Biosimilar Operational Readiness: Marketplace Trends and Regulatory Considerations

Tuesday, October 17, 2023
10:15 AM – 11:30 AM East Coast USA Time
Location: Royal
CPE
ACPE UAN:0233-0000-23-049-L04-P | Contact Hours: 1.25 | Activity Type: Knowledge-based
This activity is supported by independent medical education grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Coherus BioSciences, Inc.

Biologics, used for decades to treat a variety of inflammatory, oncologic, and other chronic conditions, have contributed to substantially improved patient outcomes. While incredibly valuable, they are also a significant proportion of health care spending in the United States. Individuals managing these complex conditions daily often experience a steep financial toll. Yet, many biologics will lose patent protection over the next three years, which analysts predict will precipitate a substantial shift in this expanding global market valued at $382 billion in 2022.

This session will provide a landscape of the biosimilars market, including the current biosimilar marketplace, anticipated launch dates for new biosimilars, and the future pipeline for these important agents. Additionally, this session will discuss how to interpret clinical effectiveness data and what research gaps currently exist with biosimilars.

Learning Objectives::

At the completion of this activity, participants should be able to:
  1. Identify evidence-based formulary considerations for the current biosimilar market, anticipated launches, and pipeline.
  2. Review biosimilar utilization trends, existing real-world outcomes, and complexities from a health-system and managed care perspective.
  3. Describe the regulatory approach to biosimilar development programs, including interpreting clinical effectiveness data.
  4. Summarize the ongoing regulatory research gaps with biosimilars and future opportunities to address these gaps.