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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