Biosimilars Coming to Diabetes Treatments: How, What, Where, and When?
Congress creates abbreviated licensure pathway for biological products similar to or interchangeable with FDA-approved products.
A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.
Prescription medications, especially those for chronic diseases like diabetes and cardiovascular disease have become a major economic burden. Due to rising diagnosis of type 1 and type 2 diabetes, it is understandable why more cost efficient biosimilar products are being developed. Diabetes biosimilar biologic products such as GLP-1 receptor agoni Continue reading