BLA number
210605
FDA Purple Book product · 351(a) biologic
Semglee
insulin glargine
Semglee, BLA 210605, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 2 exact FDA presentation rows, and 3 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.
351(a)BLA 210605 2 presentationsDiscVoluntarily Revoked Mylan Pharmaceuticals Inc.
Approved
Jun 11, 2020
License type
351(a)
Marketing
Disc
Listed patents
0
Semglee (insulin glargine) is Mylan Pharmaceuticals Inc.'s FDA-licensed 351(a) biologic under BLA 210605, approved in 2020. 3 distinct approved follow-on biologics explicitly reference Semglee (Semglee, Rezvoglar, and Langlara), making its reference-product role visible in the loaded family data.
Sourced from the FDA Purple Book · verified Sep 21, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(a) reference biologic
Applicant
Mylan Pharmaceuticals Inc.
Applicant is not automatically the physical manufacturer.
Presentations
2
Exact FDA presentation rows under this BLA.
Approval
Jun 11, 2020
Follow-on biologics
3
Semglee is a 351(a) reference biologic supported by exact-BLA evidence.
3 distinct licensed follow-on biologics in the loaded Purple Book data name Semglee as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.
Substitution boundary
Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Jun 11, 2020
6 yr 4 mo ago
Today
Strengths & presentations
2 FDA presentation rows · BLA 210605
Strength
1,000UNITS/10ML (100 UNITS/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Multi-Dose Vial
Center
CDER
License number
2210
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
300UNITS/3ML (100UNITS/ML)
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
2210
Product number
002
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 | 1,000UNITS/10ML (100 UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Voluntarily Revoked | Disc |
| 002 | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Voluntarily Revoked | Disc |
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
Not applicable to 351(a)
A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.
Human review pending
Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.
Reference product family
Biosimilars & interchangeables
3 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Semglee; 3 are designated interchangeable and 3 have a licensed status in the loaded snapshot.
Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.
- 2021SemgleeInterchangeable
insulin glargine-yfgn · Biocon Biologics Inc.
- 2021RezvoglarInterchangeable
insulin glargine-aglr · Eli Lilly and Company
- 2026LanglaraInterchangeable
insulin glargine-aldy · Sunshine Lake Pharma Co., Ltd.
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Semgleeinsulin glargine | 351(a) reference biologic | 210605 | Jun 11, 2020 | 1,000UNITS/10ML (100 UNITS/ML) · Subcutaneous | Disc |
| Semgleeinsulin glargine-yfgn | 351(k) interchangeable biosimilar | 761201 | Jul 28, 2021 | 1,000UNITS/10ML (100UNITS/ML) · Subcutaneous | Rx |
| Rezvoglarinsulin glargine-aglr | 351(k) interchangeable biosimilar | 761215 | Dec 17, 2021 | 300UNITS/3ML (100UNITS/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
2 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
Mylan Pharmaceuticals 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
Semglee is a 351(a) reference biologic supported by exact-BLA evidence. 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 Sep 21, 2026FDA release · August 2026
- monthly-downloadMonthly download · Sep 21, 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
- v6Sep 21, 2026
- v5Aug 11, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Semglee: 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.
