Table 1. Status of Biosimilar Biologic Products in the US, October 2019.
Status | No. | |
---|---|---|
Reference products | Biosimilar products | |
Launched in US | 7 | 12 |
FDA approved | 9 | 23 |
Eligible for FDA approvala | 56 | NA |
Eligible for developmentb | 111 | NA |
Abbreviations: FDA, US Food and Drug Administration; NA, not applicable.
12 years after reference product approval.
8 years after reference product approval.