Medicines these days come from a variety of sources. Some are developed using natural substances, such as plant extracts, while others are produced in a laboratory using a mixture of different chemicals. Some of the most important medications, however, are biological. That is, they are made from living organisms.
These biological products are categorized into two new types – interchangeable and biosimilar. 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 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. An interchangeable biological product is biosimilar to an FDA-approved reference product and meets…
