insulin glargine (Basaglar)
insulin glargine is an FDA-licensed reference biologic from Eli Lilly and Company, with 3 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
3
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Basaglar insulin glargine
Eli Lilly and Company
- Approved
- Nov 15, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for insulin glargine from the RCSB Protein Data Bank (PDB 6K59).
Interactive biological assembly from PDB entry 6K59. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin glargine, in chronological order.
Reference approval
Approval date of the reference insulin glargine product.
6 yr 9 mo ago
Biosimilars & interchangeables for insulin glargine
3 FDA-licensed follow-on biologics referencing insulin glargine.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Semglee | insulin glargine-yfgn | Biocon Biologics Inc. | Interchangeable | 761201 | Jul 28, 2021 |
| Rezvoglar | insulin glargine-aglr | Eli Lilly and Company | Interchangeable | 761215 | Dec 17, 2021 |
| Langlara | insulin glargine-aldy | Sunshine Lake Pharma Co., Ltd. | Interchangeable | 761412 | Apr 29, 2026 |
Frequently asked questions
What biosimilars are approved for insulin glargine (Basaglar)?
The FDA Purple Book lists 3 approved follow-on biologics referencing insulin glargine: Semglee, Rezvoglar, and Langlara. Of these, 3 are interchangeable biosimilars and 0 are 351(k) biosimilars.
Is there an interchangeable biosimilar for insulin glargine?
Yes. Semglee, Rezvoglar, and Langlara are approved as interchangeable biosimilars for insulin glargine, meaning they may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.
Who makes insulin glargine biosimilars?
Companies with FDA-approved follow-on biologics referencing insulin glargine include Biocon Biologics Inc., Eli Lilly and Company, and Sunshine Lake Pharma Co., Ltd..
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.