Differentiate between biologics, biosimilars and generics.

In broad categorization, most medicines can be divided into two segments: drugs and biologics. Drugs are small-molecule chemical compounds. Since they are synthesized from chemicals they do have the same effect all the time. A generic drug is bioequivalent to the branded product, generic drugs are same as an existing approved drug in terms of dosage form, safety quality, and performance characteristics.
On the other hand, biologics are large and complex(200-1000 times bigger than drugs) molecules. Unlike drugs, biologics are prepared within the living cells such as engineered bacteria. The key difference in biologics and drugs is that since biologics are prepared in living cells, they are less stable in comparison to the drugs and need special storage and handling process. Also, there is no surety that two doses of such medicines will be identical as minor changes keep coming due to cell errors.
Once the patent period of biologics is over various companies resort to releasing similar biologics with the approval of original manufacturer. Such follow-on biologics are called biosimilars. The key difference is the cost. Also Unlike generic medicines in which are identical to the reference drug, biosimilars will not be an identical copy of the reference biologics. Biosimilars can only be highly similar to the reference product.
Biologics & biosimilar have revolutionized the treatment of chronic illnesses such as cancer, a neurological disorder. Cost is the key for this sector and with appropriate pricing policies, after generics, biosimilar market can emerge as another growth driver for India’s pharmaceutical exports.

Question for UPSC Mains:
Differentiate between biologics, biosimilars and generics. IASPOINT | ET

Published: September 1, 2017 | Modified:June 27, 2019

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