United States · Food and Drug Administration · Biosimilars
Review target
304 days
performance goal
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
$1,124,936
FY2027
The route for a biological product that is highly similar to an already licensed reference product, with no clinically meaningful differences in safety, purity and potency. A product can also be licensed as interchangeable, which means it may be substituted for the reference product. A follow-on version of a licensed biological product.
The official review target is 304 days (performance goal, met in 90% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The biosimilar application fee, application requiring clinical data is $1,124,936 for FY2027.
1. Send the application; 2. Filing period (60 days); 3. Review (304 days); 4. Decision.
Outcome: A biologics license for the biosimilar, and if shown, a finding of interchangeability.
Legal basis: Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k))
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 364 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal, met in 90% of cases. About 10 months after the 60-day filing date, for 90 percent of original applications. This is an official target, not an actual review time. | 304 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Biosimilar application fee, application requiring clinical dataApplication · FY2027 · Under certain conditions a small business can get a waiver of the application fee. | $1,124,936 |
| Biosimilar program fee (yearly, per product)Yearly · FY2027 | $195,887 |
| Biosimilar development program, initial feeOther · FY2027 | $10,000 |
Other routes in United States: Biologics license application (351(a)), Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Regenerative medicine advanced therapy designation, Orphan drug designation, National priority voucher (pilot), Emergency use authorization, Expanded access (compassionate use), Pediatric study requirements. See all routes on the United States page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.