The First 100

Verifying the canonical approval record.

ATB is reconciling products, reference markets, review times, presentations, interchangeability, and submitted programs before rendering the report.

From One to One Hundred: A Review of the First 100 U.S. Biosimilar Approvals | ATB

00 / All Things Biosimilar · Thought Leadership

The First 100 U.S. Biosimilar Approvals

From One to One Hundred: A Review of the First 100 U.S. Biosimilar Approvals

One milestone count contains several different histories. Which products count, when they were approved, how long they took from filing to approval, and where those approvals accumulated are separate questions. This retrospective examines each in turn.

The first 100, one product at a time

Select a numbered tile to see the named biosimilar, its specific reference product, and its original FDA approval date. The letter is the product name's initial.

01 / The ATB Methodology

Biosimilars: Defining the Numbers

Before comparing dates or markets, establish what an approval count represents. Counting a named product is not the same as counting its application number or every related record.

Why four correct counts disagree

The first 100 are products, not Biologics License Application (BLA) numbers. One BLA can cover different products, while one product name can be associated with more than one BLA. Select a column to see how the answer changes when the unit of counting changes.

Count BLAs alone and distinct products disappear. Count every related record and apparent approvals multiply. ATB anchors the first 100 to named products and their specific reference products.

Jubbonti and Wyost illustrate two products under one BLA. Wezlana illustrates one named product with two BLAs. Erelzi Sensoready and Udenyca Onbody add records under existing BLAs.

Selected

What does ATB count?

100 distinct products

Each of the 100 is a distinct named biosimilar product tied to its specific reference product. The cohort is not a count of applications, presentations, or database rows.

Insights

One BLA, different products

Jubbonti and Wyost share an application but target different reference products: Prolia and Xgeva. An application-only count misses that distinction.

One product, more records

A second BLA or a device variant can add another ATB record without creating a new biosimilar product identity.

Methodology

Start with the first 100 approved product identities and their specific reference products. Count distinct recorded BLAs on those rows, then add different BLAs from matching approved secondary records. The final column counts rows, including same-BLA variants. Rows and FDA product numbers are not additional approvals. Every selected product has a recorded BLA number.

02 / Approval Rhythm

The first 100 did not arrive at a steady pace.

With the product count defined, the next question is when those approvals arrived. Annual totals show how the pace changed, without assuming that an approval meant a launch.

The pace of original approvals

Each horizontal bar counts products originally approved in that calendar year. Read from earliest to latest, then select a year to inspect its count and cumulative total.

*2026 covers approvals through Sep 25, 2026. It is not a full calendar year.

View annual approval data

Annual original approval counts
Year	Approvals	Cumulative
2015	1	1
2016	3	4
2017	5	9
2018	7	16
2019	10	26
2020	3	29
2021	4	33
2022	7	40
2023	5	45
2024	18	63
2025	27	90
2026	10	100

03 / Filing to Approval

The time from filing to approval varied widely.

The annual pace describes the cohort. Each product also has its own elapsed time from first recorded BLA receipt to original approval. Start with the distribution, then inspect every journey.

Time from filing to approval

First see how the 100 filing-to-approval intervals are distributed in 180-day groups. Then browse each product or compare approval-year summaries. These are elapsed calendar days, not FDA active-review days.

10180

59360

12540

5720

3900

31,080

01,260

11,440

21,620

21,800

11,980

02,160

12,340

02,520

02,700

02,880

03,060

03,240

03,420

03,600

03,780

13,960

Elapsed days, grouped in 180-day intervals

View distribution data

Filing-to-approval distribution
Elapsed-time range	Products	Share
0 to 179 days	0	0%
180 to 359 days	10	10%
360 to 539 days	59	59%
540 to 719 days	12	12%
720 to 899 days	5	5%
900 to 1,079 days	3	3%
1,080 to 1,259 days	3	3%
1,260 to 1,439 days	0	0%
1,440 to 1,619 days	1	1%
1,620 to 1,799 days	2	2%
1,800 to 1,979 days	2	2%
1,980 to 2,159 days	1	1%
2,160 to 2,339 days	0	0%
2,340 to 2,519 days	1	1%
2,520 to 2,699 days	0	0%
2,700 to 2,879 days	0	0%
2,880 to 3,059 days	0	0%
3,060 to 3,239 days	0	0%
3,240 to 3,419 days	0	0%
3,420 to 3,599 days	0	0%
3,600 to 3,779 days	0	0%
3,780 to 3,959 days	0	0%
3,960 to 4,051 days	1	1%

04 / Molecule Families

The first and last approvals were years apart in some families, weeks apart in others.

Now change the clock: the previous chapter follows one product from filing to approval. This one measures the distance between separate product approvals within the same molecule family.

First to last original approval

Select a molecule family to inspect its first and last products and the elapsed calendar days between those approval dates. The 4 single-product families have no comparable span.

Days from the first to last original approval date. Same-date approvals have a zero-day span, not an inferred order.

View all family approval spans and dates

First-to-last original approval dates for every molecule family in the first 100
Family	Products	First approval	Last approval	Days
Neupogen	5	Zarxio · Mar 6, 2015	Filkri · Jan 15, 2026	3,968
Neulasta	8	Fulphila · Jun 4, 2018	Ennumo · May 7, 2026	2,894
Rituxan	4	Truxima · Nov 28, 2018	Zimrixby · Jul 31, 2026	2,802
Avastin	6	Mvasi · Sep 14, 2017	Jobevne · Apr 9, 2025	2,764
Humira	10	Amjevita · Sep 23, 2016	Simlandi · Feb 23, 2024	2,709
Herceptin	6	Ogivri · Dec 1, 2017	Hercessi · Apr 25, 2024	2,337
Lantus	3	Semglee · Jul 28, 2021	Langlara · Apr 29, 2026	1,736
Lucentis	4	Byooviz · Sep 17, 2021	Ranluspec · Jun 2, 2026	1,719
Remicade	4	Inflectra · Apr 5, 2016	Avsola · Dec 6, 2019	1,340
Enbrel	2	Erelzi · Aug 30, 2016	Eticovo · Apr 25, 2019	968
Prolia + Xgeva	20	Jubbonti and Wyost · Mar 5, 2024	Degevma · Sep 25, 2026	934
Stelara	8	Wezlana · Oct 31, 2023	Starjemza · May 22, 2025	569
Actemra	3	Tofidence · Sep 29, 2023	Tyenne · Mar 14, 2025	532
Novolog	3	Merilog · Feb 14, 2025	Garzulys · Jul 24, 2026	525
Eylea	6	Opuviz and Yesafili · May 20, 2024	Eydenzelt · Oct 2, 2025	500
Soliris	2	Bkemv · May 28, 2024	Epysqli · Jul 19, 2024	52
Simponi + Simponi Aria	2	Immgolis and Immgolis Intri · May 15, 2026	Immgolis and Immgolis Intri · May 15, 2026	0
Epogen	1	Retacrit · May 15, 2018	No second product in cohort	N/A
Perjeta	1	Poherdy · Nov 13, 2025	No second product in cohort	N/A
Tysabri	1	Tyruko · Aug 24, 2023	No second product in cohort	N/A
Xolair	1	Omlyclo · Mar 7, 2025	No second product in cohort	N/A

05 / Reference-Product Markets

The first 100 were spread unevenly across reference products.

A molecule family can include more than one specific reference product. Split those families into reference-product markets to see where approved products accumulated.

Approvals by specific reference product

All 23 reference-product markets are shown. Select a bar to view its approved products in the right rail.

View all reference-product counts

Approved biosimilar count by specific reference product
Reference product	Approved biosimilars
Humira	10
Prolia	10
Xgeva	10
Neulasta	8
Stelara	8
Avastin	6
Eylea	6
Herceptin	6
Neupogen	5
Lucentis	4
Remicade	4
Rituxan	4
Actemra	3
Lantus	3
Novolog	3
Enbrel	2
Soliris	2
Epogen	1
Perjeta	1
Simponi	1
Simponi Aria	1
Tysabri	1
Xolair	1

Selected

Humira

10 approved biosimilars

View 10 named products

Amjevita · Sep 23, 2016
Cyltezo · Aug 25, 2017
Hyrimoz · Oct 30, 2018
Hadlima · Jul 23, 2019
Abrilada · Nov 15, 2019
Hulio · Jul 6, 2020
Yusimry · Dec 17, 2021
Idacio · Dec 13, 2022
Yuflyma · May 23, 2023
Simlandi · Feb 23, 2024

Insights

46 in the top five markets

The five most represented reference products account for 46 of the 100 approvals.

6 one-approval markets

6 specific reference products have only one approved biosimilar in the first 100.

Methodology

Assign each approved product to its specific 351(a) reference product, not just its shared molecule. Prolia and Xgeva therefore appear separately. These counts describe approvals in the first 100, not launches, access, utilization, or the number of distinct applications.

06 / Present-Day Context

The Next 100? Programs and Identified Opportunities

The historical analysis ends with the first 100 approvals. This separate present-day inventory shows recorded development programs and source-identified opportunities; it is not a prediction of which products will be approved next.

Tracked programs and disclosed opportunities

Two different evidence types, kept separate: 132 ATB-tracked nonapproved programs and 36 opportunity cells explicitly named in Sandoz's Bio100 presentation. Neither list predicts the next approvals.

Search programsReg. StatusReference product

ATB biosimilar development programs, one row per recorded product and specific reference assignment
Developer	Reference product	Reg. Status
Dr Reddy's	Actemra	Pre-Submission Development
Shanghai Henlius Biotech, Inc.	Benlysta	Pre-Submission Development
Alvotech	Cimzia	Pre-Submission Development
Amneal	Cimzia	Pre-Submission Development
Bio-Thera	Cosentyx	Pre-Submission Development
Mabpharm	Cosentyx	Pre-Submission Development
Celltrion	Cosentyx	BLA Submitted
Sandoz Inc.	Crysvita	Pre-Submission Development
Celltrion	Darzalex	Pre-Submission Development
Sandoz Inc.	Darzalex	Pre-Submission Development
Shanghai Henlius	Darzalex	Pre-Submission Development
Xbrane	Darzalex	Pre-Submission Development
Sandoz Inc.	Darzalex Faspro	Pre-Submission Development
Alvotech	Dupixent	Pre-Submission Development
Daewoong Pharmaceutical	Dupixent	Pre-Submission Development
Amneal	Dupixent	Pre-Submission Development
Samsung Bioepis	Dupixent	Pre-Submission Development
Sandoz Inc.	Dupixent	Pre-Submission Development
Formycon	Dupixent	Pre-Submission Development
mAbxience	Enbrel	Pre-Submission Development

Showing 1–20 of 132 matching programs

Page 1 of 7

Selected

DRL_TC

Pre-Submission Development

Developer: Dr Reddy's

Commercial partner: Dr Reddy's

Specific reference: Actemra

Insights

21 BLAs submitted

21 programs are recorded as BLA Submitted; 111 are recorded as Pre-Submission Development. Those statuses describe the ATB registry, not future outcomes.

60 reference products

132 tracked programs span 60 specifically identified reference products. For 1 program, ATB has not yet verified the specific reference product.

Methodology

Count distinct ATB biologic-product IDs with a biosimilar program classification, no FDA-approved product type, and either Pre-Submission Development or BLA Submitted status. Exclude device variants. A single molecule can have separate programs aimed at different reference products. Undisclosed candidate names remain undisclosed; an unresolved reference is labeled rather than guessed. These are observed program records, not projected approvals.

07 / References

The evidence behind the analysis.

Evidence and definitions

Open a published source by its title. ATB's curated records remain internal; their links take you to the chapter explaining the method or showing the relevant inventory. Select "Why included" for each source's role in the analysis.

01ATB curated first-100 approval setAll Things Biosimilar · ATB chapter
02ATB current development-program registryAll Things Biosimilar · ATB chapter
03ATB Sandoz-named opportunity listAll Things Biosimilar · ATB chapter
04Purple Book database of licensed biological productsU.S. Food and Drug Administration · Published source
05Degevma original BLA approval letterU.S. Food and Drug Administration · Published source
06Degevma Drugs@FDA action historyU.S. Food and Drug Administration · Published source
07Distinct products for Prolia and XgevaU.S. Food and Drug Administration · Published source
08Distinct products for Simponi and Simponi AriaU.S. Food and Drug Administration · Published source
09Sandoz Capital Markets Day 2026 presentationSandoz · Published source

ATB First 100 analysis generated October 15, 2026. Dates and program statuses are presented as recorded at the time of generation. The approval set remains the first 100 even if more products enter the live registry.

Selected

ATB curated first-100 approval set

The 100 verified product IDs, their named 351(a) references, first BLA receipt dates, original approval dates, and molecule-family assignments. Membership is held constant for the retrospective even as the live registry grows.

View related chapter

Insights

Original approval evidence

FDA approval records establish original product and date facts; ATB defines the 100-product counting set and calculates elapsed time from verified dates.

36 named Bio100 opportunities

Sandoz names these targets on its 2026 slides. ATB stores them separately from verified development programs and does not assign them a stage.

Methodology

This is a source map, not a claim that a single FDA table uses ATB's exact 100-product counting convention or that these links individually document every one of the development entries. Chapter-level counts are derived from the ATB registry. Review the counting rules in chapter 01 and the limitations alongside each analysis.

Test what you noticed

How well do you know the first 100?

Put the retrospective to work with ten questions on reference products, original approvals, specific market counts, and elapsed filing-to-approval days. Or take the optional 100-question challenge. Every product comes from this same historical cohort.

Take the First 100 quiz

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For ongoing U.S. biosimilars market coverage

This retrospective examines a defined historical cohort. The subscriber 351(k) Report covers ongoing market developments.

Explore the 351(k) Report