Langlara
Insulin glargine biosimilar developed by Sunshine Lake Pharma. Reference product Lantus.
Brands by market: Langlara (USA) · Commercial partner or holder: Sunshine Lake Pharma
FDAApr 2026approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Langlara
US Food and Drug AdministrationApprovedBrand
Langlara
Holder or applicant
Sunshine Lake Pharma Co., Ltd.
Pathway
351(k)
Approved
Apr 2026
Application or permission
761412
Licence type
351(k) interchangeable, designated Apr 2026
Presentations
100 U/mL, 3 mL pen
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAApr 2026Approved by FDA
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
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