Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment
Table 1
Differences between chemical, biological, generic, and biosimilar drugs.
Parameter
Pharmaceutical industry
Biopharmaceutical industry
Biosimilar industry
Chemical drug
Generic drug
Biological drug
Biosimilar drug
Synthesis
Production of original chemical formula
Copy from the original chemical formula
Since the insertion of a gene that plays a cell clone molecule
Development derived from the original biological molecule
Size
100–1000 Da
100–1000 Da
10.000–300.000 Da
10.000–300.000 Da
Glycosylation process
Zero
Zero
Several
Several
Molecular structure
Simple
Simple
Complex
Complex
Ability to generate immunity
Low
Low
Medium-high
Medium-high
Drug development time
7–10 years
1–3 years
10–15 years
6–9 years
Costs
US 500–800 M
<US 1-2 M
US 800–1300 M
US 10–250 M
Characterization analysis laboratory
N/A
There are techniques to identify similarity to the original drug
N/A
No identification technique equality of the molecule Clinical studies are needed
