82 FDA-approved biosimilars across 20 reference products
82
Total Biosimilars
FDA approved
20
Reference Products
With biosimilar competition
37
Interchangeable
Pharmacist-substitutable
24
Active Companies
In biosimilar market
Biosimilar Approvals by Year
FDA approval is the medical green light. Market launch is gated by patent cliffs — see Shelved Biosimilars below for biosimilars that are approved but still waiting for the reference product's patents to expire.
1
2015
3
2016
5
2017
7
2018
10
2019
4
2020
3
2021
7
2022
5
2023
18
2024
19
2025
Most Competitive Reference Products
Originator biologics with FDA-approved biosimilar competition. Higher count = more erosion pressure once patents expire. Cliff date is the US exclusivity expiry.
Ranked by biosimilar approvals. Samsung Bioepis, Celltrion, Amgen, Novartis, and Pfizer lead the field — mix of Asia-based specialists and legacy pharma diversifying into biosimilars.
SAMSUNG BIOEPIS CO LTD
9
CELLTRION INC
9
Pfizer
8
Amgen
8
Novartis
8
Fresenius Kabi
5
BIOCON BIOLOGICS INC
5
Viatris
4
ACCORD BIOPHARMA INC.
3
AMNEAL PHARMS
3
Recent Biosimilar Approvals (Last 2 Years)
All biosimilars approved by the FDA in the last 24 months. The IC badge marks interchangeable biosimilars — a pharmacist can substitute them for the reference product without calling the prescriber.
Biosimilars are biologic products highly similar to an FDA-approved reference product with no clinically meaningful differences.
They're identified by a 4-letter suffix in their generic name (e.g., adalimumab-atto).
FDA approval is the medical green light — but patents control market entry. A biosimilar can sit "shelved" for years after FDA approval if the reference product's patent thicket blocks launch. The first Humira biosimilar was approved in 2016 but couldn't launch in the US until 2023, a 6+ year gap.
