Biosimilars and Biologics

Biologics or biological products are medicines 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 cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines. Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.

A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA)

• Biologic and Biosimilar Regulations
• Switching, Substitution, and Interchangeability
• Benefits of Biosimilars and Biologics
• Clinical considerations