A new educational handbook, The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products, is now available.

This publication explains the benefits and science behind biosimilar medicines—safe, effective alternatives to costly biologic therapies. The handbook comes at a time when the Food and Drug Administration (FDA) has just approved the first biosimilar in the United States and continues to bring the day closer when American patients will have access to these medicines. 

The handbook defines biosimilars and biologics, explains who will benefit from access to these medicines, outlines the legal and regulatory framework, and illuminates the manufacturing and development process in approachable language for patients, policymakers and health experts.

Biologics are medicines made from living organisms, and they are used to treat diseases such as cancer, AIDS, heart disease, rheumatoid arthritis, multiple sclerosis and diabetes. Experts predict that by 2016, eight of the top 10 drugs on the market will be biologics. And, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.Once FDA approved, there are no clinically meaningful differences between the biosimilar and the reference (brand) biologic in terms of safety, purity and potency.



FDA has developed a free biosimilars Continuing Education (CE) course titled FDA Overview of Biosimilar Products for health care professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists. This course provides an understanding of biological and biosimilar products and a description of FDA’s general approach to the development and approval of biosimilar products.

Click here to read more from the FDA Voice blog.
Click here to access the course via the FDA education page CDERLearn.