Biologics and Biosimilars is organized by Alaska Pharmacists Association (AKPhA). This Conference has been approved for a maximum of 1.5 CPE hours.
Release Date: 8/15/17
Expiration Date: 8/15/20
The goal of this lesson is to provide an overview of biologic agents, and the subsequent biosimilar development program. FDA regulations and a general review of four U.S. FDA-approved biosimilars are included.
The development of a U.S. biosimilar program is an important advancement in healthcare as it can potentially improve access to treatment and has been shown to reduce healthcare costs in the EU. Yet, a knowledge and clinical data gap may be present for both healthcare professionals and the lay public. Additional education, clinical experience, and postmarketing data are likely needed before widespread use and confidence in these products are present in the U.S. Even though biosimilars are priced approximately 15 percent lower, this cost savings can be significant over the lifetime of treatment. As biosimilars continue to be approved, we can expect a delay in marketing and availability due to patent protection and legal battles.
At the completion of this activity, the participant will be able to:
• define a generic medication, biologic product, biosimilar product, and reference product;
• demonstrate an understanding of the legislative and regulatory information supporting biosimilar development;
• compare and contrast generic medications with biosimilar products; and
• identify approved biosimilar products in the U.S. and their approved indications.
Additional details will be posted as soon as information is available.
Biotechnology, Pharmacy and Medicine