Changeflow GovPing Drug Safety FDA Approves ARMLUPEG (Pegfilgrastim-unne) Bios...
Routine Notice Added Final

FDA Approves ARMLUPEG (Pegfilgrastim-unne) Biosimilar

Favicon for www.fda.gov FDA Biosimilar Product Approvals
Published November 28th, 2025
Detected March 12th, 2026
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Summary

The FDA has approved ARMLUPEG (pegfilgrastim-unne), a biosimilar drug manufactured by LUPIN LTD. This approval marks the addition of a new biosimilar product to the market, following the FDA's review process.

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What changed

The U.S. Food and Drug Administration (FDA) has approved ARMLUPEG (pegfilgrastim-unne) under Biologic License Application (BLA) 761212, manufactured by LUPIN LTD. This approval signifies the addition of a new biosimilar product to the market, specifically for pegfilgrastim-unne, indicated for prescription use.

This action is primarily informational for the pharmaceutical industry. While it represents a new product approval, it does not impose new compliance obligations or deadlines on regulated entities. Companies involved in biosimilar development or marketing may note this as a market entry for a competitor or a potential benchmark for their own products.

Source document (simplified)

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Biologic License Application (BLA): 761212
Company: LUPIN LTD
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Products on BLA 761212

| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ARMLUPEG | PEGFILGRASTIM-UNNE | 6MG/0.6ML | INJECTION;SOLUTION | Prescription | None | No | No |

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761212

Original Approvals or Tentative Approvals

| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11/28/2025 | ORIG-1 | Approval | | N/A | Letter (PDF)
Review
Review | Label is not available on this site. | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761212Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761212Orig1s000TOC.html
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761212Orig1s000TOC.html |

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Source

Favicon for www.fda.gov
FDA Biosimilar Product Approvals fda.gov/drugs/biosimilars/biosimilar-product-information
Drug Safety
Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Food and Drug Administration
Published
November 28th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Geographic scope
National (US)

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Biosimilars Pharmaceuticals

Browse Categories

Federal Courts 26 State Courts 91 Securities Regulation 6 Financial Regulation 43 Consumer Protection 5 Drug Safety 45 Data Protection 21 Competition 2 Attorneys General 3 Insurance Regulation 5 Trade & Export 36 Legislation 42 Energy Regulation 13 Environment 3 Labor & Employment 2 Tax 1

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