Update on Biosimilars: An Emerging Category of Biologic Drugs
John Fanikos, MBA, RPh
Assistant Director of Pharmacy
Brigham and Women’s Hospital
Assistant Professor of Clinical Pharmacy
Northeastern University, Massachusetts College of Pharmacy
Kathryn Jenkins, Pharmacy Candidate
Professor of Clinical Sciences
University of Delaware, College of Arts and Sciences
Kevin Day, Pharmacy Candidate
Department of Pharmacy Services
Brigham and Women’s Hospital
FACULTY DISCLOSURE STATEMENTS:
John Fanikos, MBA, RPh, Kathryn Jenkins, Pharmacy Candidate, and Kevin Day, Pharmacy Candidate, have no relevant affiliations or financial relationships with a commercial interest to disclose.
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Credits: 2.0 hours (0.20 CEUs)
Type of Activity: Knowledge
This accredited activity was designed for pharmacists.
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The U.S. is now poised to introduce generic versions of biologics, currently referred to as biosimilars. Biosimilars are copies of therapeutic proteins intended to offer comparable safety and efficacy to the reference biologic. Controversy exists regarding whether these products are considered identical or similar and substitutable or interchangeable. Pharmacists will be managing many of these issues and playing an active role in assisting clinicians and patients with making informed health care decisions.
After completing this activity, the participant should be able to:
- Discuss the differences between biologic and biosimilar agents and how biosimilars differ from conventional small molecule generic drugs;
- Explain potential issues related to the storage, preparation, administration, safety, and efficacy of biosimilars;
- Describe the current United States (U.S.) approval pathways for biosimilars;
- Discuss U.S. Food and Drug Administration (FDA) requirements for establishing biosimilarity, interchangeability, and issues surrounding nomenclature and postmarketing surveillance;
- Discuss the introduction of biosimilars in Europe and the outstanding issues and requirements for their launch in the U.S.;
- Identify and discuss issues related to both product efficacy and patient safety for biologics and biosimilar agents; and
- Analyze pharmacoeconomic issues related to biosimilar use in the U.S.