Biologics or biological medicines or products which are made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics include a wide variety of products such as gene and therapeutic proteins, cell therapies, vaccines and monoclonal antibodies. Biologics are used to treat, cure and prevent a variety of diseases including cancer, diabetes, chronic kidney disease, cystic fibrosis, and autoimmune disorders. Biologics are very specific and highly effective medications prepared with living cells. They improve health in many complex conditions, including, cancer, Crohn’s disease, diabetes, ulcerative colitis, rheumatoid arthritis, osteoporosis, multiple sclerosis, psoriasis, HIV, growth deficiencies, and more. Patients are given biologics by injection or infusion and because we cannot take them orally, since the process of digestion breaks down the biologic, making it ineffective.
Biosimilars are products that are similar to an already officially existing brand-name, original biologic innovator or originator biologic but, unlike a generic drug, are not identical. To understand why, we need to look at how biologics are different from other medicines. Other than with generic drugs of the more common small-molecule type, biologics generally show the high molecular complexity and may be quite sensitive to the changes in the process of manufacturing. Despite that heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.