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Generics & Biosimilars

First Mover the Biosimilars market with Leading-Edge Technology

Differences between Generics and Biosimilars

Unlike generics that are produced through replication of chemically synthesized pharmaceuticals, Biosimilars require technical prowess and have prolonged periods of development time and high production costs.

Generics

Generics product
Replication is easy as long as the chemical formula of the original pharmaceutical product is known
Replication is fast and inexpensive as it is done by chemical synthesis
Time taken for development:
2~3 years
Cost:
20~30 billion KRW

1st Generation Biosimilars

1st Generation Biosimilars product
Exact replication is impossible due to subtle differences in the final products resulting from varying culture conditions and purification methods.
Thus, ‘Biosimilars’ are defined as being highly ‘similar’ to the original product.
The relatively simple molecular structure allows for lower cost and faster development
Time taken for development:
3~5 years
Cost:
100~150 billion KRW

2nd Generation Biosimilars

2nd Generation Biosimilars
Exact replication is impossible due to subtle differences in the final products resulting from varying culture conditions and purification methods.
Thus, ‘Biosimilars’ are defined as being highly ‘similar’ to the original product.
Intricate molecular structure leading to difficulties in development, causing immense expenditure and high market barriers
Time taken for development:
5~10 years
Cost:
300 billion KRW

Difficulties in the Development of Biologics

Compared to chemically synthesized pharmaceuticals, biologics display complex crystal structures resulting in a more challenging process for development and production.
Differences in the level of technology required for the development of biologics compared to generic pharmaceuticals are analogous to the technological differences observed between development of a bicycle, automobile and airplane.

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