Changeflow GovPing Drug Safety FDA Approves Filgrastim-LAHA Biosimilar
Routine Notice Added Final

FDA Approves Filgrastim-LAHA Biosimilar

Favicon for www.fda.gov FDA Biosimilar Product Approvals
Published January 15th, 2026
Detected March 12th, 2026
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Summary

The FDA has approved FILKRI (filgrastim-LAHA), a biosimilar product, for ACCORD BIOPHARMA INC. The approval was granted on January 15, 2026, under Biologic License Application (BLA) 761027. This marks the addition of a new biosimilar option to the market.

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What changed

The U.S. Food and Drug Administration (FDA) has approved FILKRI (filgrastim-LAHA), a biosimilar drug, for Accord Biopharma Inc. under Biologic License Application (BLA) 761027. The approval, effective January 15, 2026, adds a new biosimilar product to the market, offering an alternative to existing treatments.

This approval is primarily informational for drug manufacturers and pharmaceutical companies. No immediate compliance actions are required for other entities based on this specific approval notice. Compliance officers should note the addition of this biosimilar to the market for potential future strategic considerations regarding drug sourcing or competitive analysis.

Source document (simplified)

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Biologic License Application (BLA): 761027
Company: ACCORD BIOPHARMA INC.
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Products on BLA 761027

| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
| --- | --- | --- | --- | --- | --- | --- | --- |
| FILKRI | FILGRASTIM-LAHA | 300MCG/0.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| FILKRI | FILGRASTIM-LAHA | 480MCG/0.8ML | INJECTABLE;INJECTION | Prescription | None | No | No |

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761027

Original Approvals or Tentative Approvals

| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 01/15/2026 | ORIG-1 | Approval | | N/A | Label (PDF)
Letter (PDF) | | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761027s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761027Orig1s000ltr.pdf |

Labels for BLA 761027

| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels,
Patient Package Insert | Note | Url |
| --- | --- | --- | --- | --- | --- |
| 01/15/2026 | ORIG-1 | Approval | Label (PDF) | | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761027s000lbl.pdf |

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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
January 15th, 2026
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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