Overview
Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, FDA has granted licensure to 10 biosimilar products. However, only three biosimilars are available on the market. Furthermore, uptake of some of these biosimilars has been less than initially anticipated. There are several barriers to the successful commercialization of biosimilars in the US. These include lack of understanding about this new category of biologics, various commercial challenges, and numerous different types of legal challenges. This virtual session will delve into the types of barriers to uptake that biosimilars are currently facing in the US and how the biosimilar landscape may evolve to address these challenges.
Featured Topics
- Lack of Understanding: Perception Challenges and Misinformation
- Effectiveness and safety of biosimilars
- Extrapolation
- Quality of biosimilars vs interchangeable biologics
- Physician-initiated switching and pharmacists-initiated switching (substitution and interchangeability)
- Commercial Challenges
- Educating health system stakeholders
- Restrictive formularies
- Contracting
- Rebates
- Medicaid/Medicare
- How these challenges can vary based on the type of market (e.g. bill and buy, chronic use, etc.)
- Legal Challenges
- Extensive patent estates
- Inter Parties Review
- Unresolved questions from BPCIA
- Settlements between originator and biosimilar companies
Back to the Biosimilars Virtual Conference.
Learning objectives
At the conclusion of this session, participants should be able to:
- Describe the current barriers to uptake facing biosimilars in the US
-
Discuss how the US biosimilar landscape may evolve in the future to address these challenges
The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 1.5 contact hours or .15 CEUs. 0286-0000-18-062-H04-P Type of Activity: Knowledge
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program.
In order to request your online credit through My Transcript, visit www.diaglobal.org, select “Sign in” and you will be prompted for your user ID and password (if you do not know your username and password, choose Forgot Your User ID/Password). Find EVENTS, select “Continuing Education”. Select the blue “My Transcript” button followed by “Credit Request”.
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Program Committee
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Leah Christl, PhD Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Amgen, United States -
Hillel P Cohen, PhD Executive Director, Scientific Affairs
Sandoz Inc., United States -
Thomas Felix, MD Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Amgen Inc., United States -
Julie Marechal-Jamil, MSc Director, Biosimilar Policy and Science
Medicines For Europe, Belgium -
Laura McKinley, PhD Director, Global Regulatory Policy and Intelligence
Pfizer Inc, United States -
Cecil J. Nick, MS FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom -
Jian Wang, MD, PhD Division Manager, Clinical Review Division – Heamatology/Oncology
Health Canada, Canada
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