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. 2020 Oct 5;181(1):1–9. doi: 10.1001/jamainternmed.2020.3997

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.

a

12 years after reference product approval.

b

8 years after reference product approval.