FDA Releases Online Course on Biosimilars

February 18, 2016
Pharmaceutical Technology Editors

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

On Feb. 18, 2016, FDA released an online resource for health care professionals on biosimilars. The CDERLearn continuing education (CE) credit course for health care professionals on biosimilars is titled FDA Overview of Biosimilar Products.

The 90-minute course is intended to help health care professionals make informed decisions when considering, prescribing, or dispensing biosimilar products.  The course also provides a general review of FDA’s process for biosimilar product development programs. 

The course will give a basic overview of the regulations granting FDA authority to review and approve biosimilar products, and information about the science-based approach the FDA has taken to support biosimilar development. FDA stated that the target audience for the course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists.

In a press announcement from the agency, FDA said that its “high standard for approval of biosimilar products means that patients and healthcare professionals can rely upon the safety and effectiveness of a biosimilar product, just as they would the reference product.” The course is available for free on FDA’s website

Source: FDA