Question

‘Biosimilars and generics are not the same.’ Discuss this statement in detail and supplement your answer with relevant examples. [50]

Answer 1

Answer :

When a drug company introduces a costly new drug, they can do so because they have exclusive patent on it. Once the drug patent expires, pharmaceutical companies can copy that branded drug and sell it for less as generic.

Example Amoxycillin clavulinic acid the primary brand is GSK. Then other brands copied drug for lesser prices as generic under brand names MOXCLAV, Co-AMOXICLAV etc.

For generic drugs cost to manufacturer and consumer are very less as approval pathway is much shorter than branded drugs. Generics dont require additional cost and time for research and development as they are tested earlier and approved drugs.

There is lot of variety in how these molecules are positioned and the analytical methodologies that exist today are limited in the degree to which they can confirm absolute identity of all aspects of the molecule.

As there was no assurance that the large protein molecule drugs are chemically identical its debatable to call large protein molecule drugs generic. This lead to the birth of biosimilars. Biosimilars have a same clinical effect as a generic but only as similar to the original drug as validation technologies can confirm.

Generics are the default choice as they are lower priced. But generics are different than biosimilars because they are considered equivalents.

In the case of biosimilars for large molecules its still quite expensive. In some countries biosimilars are preffered. Biosimilar manufacturers concentrate on proteins of higher complexity, requiring high costs and even more sophisticated manufacturing.

With only one biosimilar currently on the market and two or three to come in United States. There are many approved and in circulation in Europe.