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Total number of biosimilars approved until 2023 by the eight countries analyzed.
| Countries and Sources | Total Number Approved | Regulatory Framework for Biosimilars |
|---|---|---|
| Canada [134] | 53 (September 2023) | CMA |
| Brazil [135] | 52 (May 2023) | ANVISA |
| United States [136] | 45 (December 2023) | FDA |
| Australia [137] | 43 (September 2023) | TGA |
| Japan [138] | 32 (December 2022) | PMDA |
| South Korea [108] | 25 (December 2022) | MFDS |
| Argentina [126] | 24 (December 2022) | ANMAT |
| South Africa [139] | 5 (November 2020) | SAHPRA |
