BLA number
761412
FDA Purple Book product · Interchangeable
Langlara
insulin glargine-aldy
Langlara, BLA 761412, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 1 exact FDA presentation row, and FDA names Lantus 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 761412RxLicensed Sunshine Lake Pharma Co., Ltd.
Approved
Apr 29, 2026
License type
351(k) Interchangeable
Marketing
Rx
Listed patents
0
Langlara (insulin glargine-aldy) is a Interchangeable referencing insulin glargine, licensed under a 351(k) BLA in 2026; the Purple Book lists Sunshine Lake Pharma Co., Ltd. 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.
Sourced from the FDA Purple Book · verified Aug 11, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(k) interchangeable biosimilar
Applicant
Sunshine Lake Pharma Co., Ltd.
Applicant is not automatically the physical manufacturer.
Presentations
1
Exact FDA presentation rows under this BLA.
Approval
Apr 29, 2026
Reference product
Lantus
Langlara is an FDA-designated interchangeable biosimilar.
Langlara is a 351(k) biosimilar of Lantus 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.
Apr 29, 2026
4 mo ago
Today
Pharmaceutical detail
FDA product record
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
2343
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.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 300UNITS/3ML (100UNITS/ML) | 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
Langlara names Lantus 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 Lantus
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Lantusinsulin glargine | 351(a) ambiguous reference candidate | 21081 | Apr 20, 2000 | 1,000UNITS/10ML (100UNITS/ML) · Subcutaneous | Rx |
| Basaglarinsulin glargine | 351(a) ambiguous reference candidate | 205692 | Dec 16, 2015 | 300UNITS/3ML (100UNITS/ML) · Subcutaneous | Disc |
| Semgleeinsulin glargine | 351(a) ambiguous reference candidate | 210605 | Jun 11, 2020 | 1,000UNITS/10ML (100 UNITS/ML) · Subcutaneous | Disc |
| Toujeoinsulin glargine | 351(a) ambiguous reference candidate | 206538 | Feb 25, 2015 | 450UNITS/1.5ML (300UNITS/ML) · Subcutaneous | Rx |
| Langlarainsulin glargine-aldy | 351(k) interchangeable biosimilar | 761412 | Apr 29, 2026 | 300UNITS/3ML (100UNITS/ML) · Subcutaneous | Rx |
Published patents
BPCIA patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Practical characteristics and limits
Source-bounded interpretation
Presentation coverage
1 exact FDA presentation row is 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
Sunshine Lake Pharma Co., Ltd. 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
Langlara 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, 2026FDA release · June 2026
- 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
- v4Aug 11, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
- v1Jul 02, 2026
Langlara: 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
