Biological/Biosimilar Drugs: A New Hope for Better and Low Cost Treatment
Abstract
Biological and biosimilar drugs
Medicines that are derived from living cells/organisms are
known as biological medicines. They consist of of highly complex
molecular entities difficult to characterize. Certain degree of
variations might found among biological medicines due to
variation of the biological system and manufacturing process.
A medicine that is very similar and clinically equivalent to a
biological medicine is known as biosimilar medicine. Reference
or originator medicine is an already approved biological medicine
from which a biosimilar active medicine is derived. The biological
product is highly similar to the reference product not withstanding
minor differences in clinically inactive components; and there
are no clinically meaningful differences between the biological
product and the reference product in terms of the safety, purity,
and potency of the product. Biosimilar medicines are not the
same as generic medicines, which contain simpler chemical
structures and are identical, in terms of molecular structure, to
their reference drugs [1].