The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
Today, FDA released an online, CDERLearn continuing education (CE), credit course for health care professionals about biosimilars: “FDA Overview of Biosimilar Products.” 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 biosimiliars 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.