[R2] Biosimilar Operational Readiness: Marketplace Trends and Regulatory Considerations

Pricing: Free for Members and Non-Members

This session is supported by independent medical education grants from Boehringer Ingelheim Pharmaceuaticals, Inc. and Coherus BioSciences, Inc.

Course Description

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.

Target Audience

Pharmacists who practice in managed care settings.

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.
Course summary
Available credit: 
  • 1.25 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 1.25 Certificate of Completion
Course opens: 
11/15/2023
Course expires: 
12/31/2024
Cost:
$0.00

Faculty

Chelsee Jensen, PharmD, BCPS
Senior Pharmacy Specialist
Pharmaceutical Formulary Manager
Mayo Clinic

Kimberly Maxfield, PhD
Pharmacologist
FDA

Juwaria Waheed, MD
Scientific Reviewer
FDA/CDER/OND/OTBB
Office of Therapeutic Biologics and Biosimilars

Moderator

Cate Lockhart, PharmD, PhD
Executive Director
BBCIC

Financial Relationship Disclosures

 

Faculty/Reviewer/Planner​

Reported Relevant Financial Relationships​

Chelsee Jensen​

Faculty​

Consultant: Aptitude Health Cases and Amgen​

Kimberly Maxfield​

Faculty​

Disclosed no relevant financial relationships.​

Juwaria Waheed​

Reviewer​

Disclosed no relevant financial relationships.​

​

Susanne Dudash​

Reviewer​

Employee: Express Scripts (PBM, non-contracting role)​

Ruby Singh​

Planner​

Disclosed no relevant financial relationships.​

​

  • AMCP Staff have disclosed no relevant financial relationships.
  • If applicable, relevant financial relationships have been mitigated and documented.
  • Content has undergone a peer review to ensure content validity.

ACPE UAN:0233-0000-23-049-H04-P
Activity Type: Knowledge-Based
Contact Hours: 1.25
Release Date: November 15, 2023 •  Expiration Date: December 31, 2024
Activity Fee: Free for Members and  Non-Members

Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at Nexus 2023. CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor. Please allow 72 hours for processing and posting in your NABP account.

To receive credit for an online activity you must:

  • Review the full content of the activity.
  • Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
  • Complete a specific activity evaluation.

Available Credit

  • 1.25 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 1.25 Certificate of Completion

Price

Cost:
$0.00
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