Langlara

Insulin glargine biosimilar developed by Sunshine Lake Pharma. Reference product Lantus.

Brands by market: Langlara (USA) · Commercial partner or holder: Sunshine Lake Pharma · Company profile

FDAApr 2026approved

EMANot listed

MHRANot listed

PMDANot listed

HCNot listed

CDSCONot listed

EDENot listed

Approved or registered in 1 of 7 markets

Connections

Insulin glarginemolecule Sunshine Lake Pharmadeveloper 1 of 7markets 0trials behind it 0other products, same developer 2rival developers in its markets

About Langlara

Langlara is an insulin glargine from Sunshine Lake Pharma of China, approved in the United States in April 2026 and interchangeable from the start. It is the third insulin glargine biosimilar in the United States and the first from a Chinese developer.

Status by market

FDA

United States · Langlara

US Food and Drug AdministrationApproved

Brand

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

Reference product in the Purple Book

Lantus

Marketing status (Purple Book)

Prescription, marketed

Presentations

100 U/mL, 3 mL pen

Source

S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Langlara holds an approval, these are the other insulin glargine biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	2	Biocon Biologics (Semglee), Eli Lilly (Rezvoglar / Abasaglar)

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)

All insulin glargine biosimilars

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Data current to September 2026.