What is Simlandi in the FDA Purple Book?

Simlandi, BLA 761299, is listed as a 351(k) interchangeable biosimilar with 5 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 761299?

Simlandi, BLA 761299, lists Alvotech USA Inc. as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Simlandi?

Simlandi, BLA 761299, has 5 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Simlandi's reference-product relationship?

Simlandi, BLA 761299, lists Humira as its FDA reference product. The loaded row does not supply a reference BLA number, so this page does not invent one from a name match.

When was Simlandi licensed by FDA?

Simlandi, BLA 761299, has a listed FDA approval date of Jun 26, 2024. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Simlandi's FDA label?

Simlandi, BLA 761299, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Simlandi?

Simlandi, BLA 761299, has 66 published Purple Book patent rows, with the latest listed expiration on Nov 14, 2034. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Simlandi?

Simlandi, BLA 761299, has 1 populated Purple Book exclusivity field, with the latest listed date on May 20, 2025. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · Interchangeable

Simlandi

adalimumab-ryvk

Simlandi, BLA 761299, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 5 exact FDA presentation rows, and FDA names Humira as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(k) InterchangeableBLA 761299 5 presentationsRxLicensed Alvotech USA Inc.

Approved

Jun 26, 2024

License type

351(k) Interchangeable

Marketing

Listed patents

Simlandi (adalimumab-ryvk) is a Interchangeable referencing adalimumab, licensed under a 351(k) BLA in 2024; the Purple Book lists Alvotech USA Inc. as the BLA applicant, not necessarily the manufacturer or commercial supplier. Its interchangeable biosimilar designation may permit pharmacy-level substitution for the reference product without prescriber intervention, subject to state law; it is not a superiority claim. The Purple Book lists 66 published patents for this product.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

761299

Regulatory role

351(k) interchangeable biosimilar

Applicant

Alvotech USA Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Jun 26, 2024

Reference product

Humira

Simlandi is an FDA-designated interchangeable biosimilar.

Simlandi is a 351(k) biosimilar of Humira and carries an interchangeability designation.

Substitution boundary

An interchangeable designation may permit pharmacy-level substitution for the reference product without prescriber intervention, depending on state pharmacy law; it is not a claim of clinical superiority.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Jun 26, 2024
2 yr 3 mo ago
First interchangeable exclusivity ends
Window blocking subsequent interchangeable approvals for the reference product.
May 20, 2025
1 yr 4 mo ago
Today

Strengths & presentations

5 FDA presentation rows · BLA 761299

Strength

40MG/0.4ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

2225

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	40MG/0.4ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx
002	40MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
003	20MG/0.2ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
004	80MG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
005	80MG/0.8ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

FDA approval evidence

Exact-source research required

No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

Simlandi names Humira as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.

Biosimilar of Humira

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Humiraadalimumab	351(a) name-matched reference candidate	125057	Dec 31, 2002	40MG/0.8ML · Subcutaneous	Rx
Simlandiadalimumab-ryvk	351(k) interchangeable biosimilar	761299	Jun 26, 2024	40MG/0.4ML · Subcutaneous	Rx

Published patents

BPCIA patent list

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
8,911,737	Jun 05, 2022	4 yr 4 mo ago	FDA
8,974,790	Jun 05, 2022	4 yr 4 mo ago	FDA
8,992,926	Jun 05, 2022	4 yr 4 mo ago	FDA
9,546,212	Jun 05, 2022	4 yr 4 mo ago	FDA
6,805,686	May 06, 2023	3 yr 5 mo ago	FDA
8,906,373	Jul 18, 2023	3 yr 3 mo ago	FDA
9,067,992	Jul 18, 2023	3 yr 3 mo ago	FDA
9,085,620	Jul 18, 2023	3 yr 3 mo ago	FDA
9,090,689	Jul 18, 2023	3 yr 3 mo ago	FDA
8,961,973	Apr 11, 2025	1 yr 6 mo ago	FDA
8,961,974	Apr 11, 2025	1 yr 6 mo ago	FDA
8,986,693	Apr 11, 2025	1 yr 6 mo ago	FDA
9,061,005	Apr 11, 2025	1 yr 6 mo ago	FDA
9,187,559	Apr 11, 2025	1 yr 6 mo ago	FDA
9,512,216	Apr 11, 2025	1 yr 6 mo ago	FDA
8,808,700	May 16, 2026	4 mo ago	FDA
11,083,792	Apr 04, 2027	in 7 mo	FDA
8,231,876	Apr 04, 2027	in 7 mo	FDA
8,883,156	Apr 04, 2027	in 7 mo	FDA
8,895,009	Apr 04, 2027	in 7 mo	FDA
8,906,372	Apr 04, 2027	in 7 mo	FDA
8,916,153	Apr 04, 2027	in 7 mo	FDA
9,096,666	Apr 04, 2027	in 7 mo	FDA
9,102,723	Apr 04, 2027	in 7 mo	FDA
9,273,132	Apr 04, 2027	in 7 mo	FDA
9,328,165	Apr 04, 2027	in 7 mo	FDA
9,913,902	Apr 04, 2027	in 7 mo	FDA
8,926,975	Jun 08, 2027	in 9 mo	FDA
8,715,664	Jul 24, 2027	in 10 mo	FDA
8,663,945	Sep 13, 2027	in 1 yr	FDA
8,906,646	Sep 13, 2027	in 1 yr	FDA
8,911,964	Sep 13, 2027	in 1 yr	FDA
9,090,867	Sep 13, 2027	in 1 yr	FDA
9,234,032	Sep 13, 2027	in 1 yr	FDA
9,284,371	Sep 13, 2027	in 1 yr	FDA
8,889,136	Oct 09, 2027	in 1 yr 1 mo	FDA
9,284,370	Jun 10, 2028	in 1 yr 9 mo	FDA
9,669,093	Jun 10, 2028	in 1 yr 9 mo	FDA
11,167,030	Nov 28, 2028	in 2 yr 3 mo	FDA
11,191,834	Nov 28, 2028	in 2 yr 3 mo	FDA
9,085,619	Nov 28, 2028	in 2 yr 3 mo	FDA
8,420,081	Jan 13, 2030	in 3 yr 4 mo	FDA
8,999,337	Feb 06, 2031	in 4 yr 5 mo	FDA
9,624,295	Mar 31, 2031	in 4 yr 7 mo	FDA
8,708,968	Jan 24, 2032	in 5 yr 5 mo	FDA
9,339,610	Jan 24, 2032	in 5 yr 5 mo	FDA
9,062,106	Apr 26, 2032	in 5 yr 8 mo	FDA
9,090,688	Apr 26, 2032	in 5 yr 8 mo	FDA
9,505,834	Apr 26, 2032	in 5 yr 8 mo	FDA
9,522,953	Apr 26, 2032	in 5 yr 8 mo	FDA
9,683,033	Apr 26, 2032	in 5 yr 8 mo	FDA
9,957,318	Apr 26, 2032	in 5 yr 8 mo	FDA
9,085,618	Mar 14, 2033	in 6 yr 7 mo	FDA
9,181,337	Mar 14, 2033	in 6 yr 7 mo	FDA
9,181,572	Mar 14, 2033	in 6 yr 7 mo	FDA
9,290,568	Mar 14, 2033	in 6 yr 7 mo	FDA
9,334,319	Mar 14, 2033	in 6 yr 7 mo	FDA
9,346,879	Mar 14, 2033	in 6 yr 7 mo	FDA
9,359,434	Mar 14, 2033	in 6 yr 7 mo	FDA
9,499,616	Mar 14, 2033	in 6 yr 7 mo	FDA
9,708,400	Mar 14, 2033	in 6 yr 7 mo	FDA
9,315,574	Apr 21, 2033	in 6 yr 8 mo	FDA
9,150,645	May 13, 2033	in 6 yr 9 mo	FDA
9,266,949	May 13, 2033	in 6 yr 9 mo	FDA
9,499,614	Mar 14, 2034	in 7 yr 7 mo	FDA
9,550,826	Nov 14, 2034	in 8 yr 3 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

5 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Alvotech USA Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Simlandi is an FDA-designated interchangeable biosimilar. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Aug 11, 2026

FDA release · June 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Simlandi: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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