FDABiosimilarsOnlineFeb2016New FDA Overview of Biosimilar Products

The U.S. Food and Drug Administration on Frebruary 18, 2016 released an online CDERLearn continuing education credit course for health care professionals about biosimilars: “FDA Overview of Biosimilar Products.”

According to the FDA, this continuing education (CE) course provides an understanding of biological products and biosimilar products and a description of FDA’s general approach to the development and approval of biosimilar products. The target audience for this course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and that has no clinically meaningful differences in terms of safety and effectiveness from the reference biologic product. FDA was granted legal authority to evaluate biosimilars in March 2010 under the Biological Price Competition and Innovation (BPCI) Act as part of the Affordable Care Act.

The 90-minute course shares important information about the new type of biological product 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 provide a basic knowledge of the regulations granting FDA authority to review and approve biosimilar products, and information about the rigorous and science-based approach the FDA has taken to support their development.  FDA’s high standard for approval of biosimilar products means that patients and health care professionals can rely upon the safety and effectiveness of a biosimilar product, just as they would the reference product.

FDA also published a FDAVoice blog by Leah Christl, Ph.D., Associate Director for Therapeutic Biologics in the Office of New Drugs, at the Center for Drug Evaluation and Research at FDA.