For decades, everybody has become familiar with many brand-name and generic chemically synthesized drugs that are small molecule drug products, such as amoxicillin, Lipitor, and Crestor. Biological products, on the other hand, are practically and conceptually different as a class of therapeutic medicinal products. Biological products may be broadly considered inclusive of vaccines, blood components, or proteins (unless chemically synthesized polypeptides), as well as other defined products. Currently in the United States, a number of biological products have been approved for prevention of diseases (e.g., vaccines), for treatment of autoimmune diseases (e.g., arthritis, psoriasis), and for treatment of cancer (e.g., non-Hodgkin lymphoma, some types of colorectal cancer).

As the proliferation of biologic products continues, so will the proliferation of biosimilar products with respect to innovator products, also known as the reference biologic product (RBP) to which a biosimilar is compared. Consequent to the expanded development and approval of biosimilars will be determining whether a biosimilar product is interchangeable with, and can be used in lieu of, an RBP.

From AAPS Blog by BY LOAN PHAM AND VIEN LAI