What are biologics?
Unlike drugs, which are chemically synthesized, biologics are complex mixtures not easily identified or
characterized. They include:
Allergenics, such as patch tests used to diagnose causes of dermatitis and extracts used to diagnose and treat hay fever, allergic sinusitis, allergic conjunctivitis, and bee stings
Blood and blood components including red blood cells, platelets, and plasma
Pharmaceutical products made from blood including immunoglobulins and clotting factors
Medical devices and tests used to safeguard blood and blood components
Cellular products, such as human stem cells and pancreatic islet cells
Gene therapies
Human tissues, including skin, tendons, ligaments, and cartilage
Vaccines
Xenotransplantation products that use live animal cells, tissues, or organs to treat human diseases such as liver failure and diabetes, where human materials are not always available
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