what is a biosimilar drug

10 months ago 20
Nature

A biosimilar drug is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biologics are highly complex molecules that are grown rather than synthesized and have an inherent level of micro-variability. Because of this variability in the structure of reference biologics, biosimilars cannot be exact copies. Instead, biosimilars mimic the active ingredient in the reference biologic. Biosimilars are officially approved versions of original "innovator" products and can be manufactured. Biosimilars are similar to generic drugs in that they provide patients with lower-cost medicines, often making these treatments more accessible and improving quality of life for patients. However, unlike generic drugs, biosimilars are not exact copies of their brand name drug. Biosimilars undergo extensive analysis to confirm they have the same characteristics as the reference biologics, and studies must show that there are no differences in the safety and effectiveness of biosimilars and the original biologics. Biosimilars are safe and effective treatment options for many illnesses such as chronic skin and bowel diseases, arthritis, kidney conditions, and cancer.