What is the difference between Biologic and Bio similar ?


Biologic or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. 

Biologic: A biological product or biologic, is a preparation, such as a therapeutic drug, monoclonal antibodies or vaccines, that is made from living organisms (such as microorganisms, animal cell or plant cell). Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Patients receives biologics by injection under skin (subcutaneously) or by intravenous infusion and cannot take them orally, since the digestive process break down the biologic and make them ineffective.

Bio similar: A Bio similar is similar but not identical to a brand name biologic medicine (reference product). Bio similar has the same mechanism of action, route of administration, dosage form, and strengths as the brand name biologic medicine (reference product). Bio similar is highly similar, but not structurally identical and exact replicas of the brand-name biologic; there can be minor differences in clinically inactive components. Because biologics are more complex than chemical drugs, both in composition and method of manufacture. Since bio similars are not identical, they are not generic versions of the biologic they are copying, but they are affordable alternatives that work similarly and are shown in studies to have equivalent outcomes. 

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