A biologic medical product, also known as a biological product, or more simply as a biologic or biological, is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells that are used as therapeutics to treat diseases. Biologics are created by biologic processes, rather than being chemically synthesized.
Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
In some jurisdictions, biologics are regulated through varied regulatory pathway other than small molecule drugs and medical devices.
Read more about Biologic Medical Product: Biosimilars
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