Biologic medications are made from natural and living sources, such as animal and plant cells, as well as microorganisms, such as bacteria or yeast.
Biologic agents are used for treating many illnesses, such as chronic skin and bowel diseases (for example, psoriasis, irritable bowel syndrome (IBS), Crohn’s Disease and Colitis), arthritis, kidney conditions, and cancer.
Biosimilars are biologic agents that are very close, but not an exact match, with the original reference medication. The biosimilar drug development pathway differs from the pathway for conventional medications. These products are introduced to help reduce the costs of biologics.
A biosimilar medication is approved by the U.S. Food and Drug Administration (FDA) after rigorous evaluation and testing by the drug applicant. It is approved by the FDA only after proving there are no clinically meaningful differences in safety, purity or potency (safety and effectiveness), as compared to the reference product.
Manufacturers generally name them by combining the current non-proprietary name (such as infliximab or adalimumab) with a four-letter suffix. Examples are Infliximab-dyyb and Adalimumab-atto.
Biosimilars are similar to generics in some ways. Both are approved through different abbreviated pathways that avoid duplicating costly clinical trials. Generic medications are often made from chemical ingredients, while biosimilars which are generally made from natural and living ingredients.