Changeflow GovPing Drug Safety FDA Approves Ranibizumab-leyk Biosimilar (NUFYMCO)
Routine Notice Added Final

FDA Approves Ranibizumab-leyk Biosimilar (NUFYMCO)

Favicon for www.fda.gov FDA Biosimilar Product Approvals
Published December 18th, 2025
Detected March 12th, 2026
Email

Summary

The FDA has approved the Biologic License Application (BLA) 761473 for NUFYMCO (ranibizumab-leyk) from FORMYCON AG. This approval marks the addition of a new biosimilar product to the market.

View original document View source feed page

What changed

The U.S. Food and Drug Administration (FDA) has approved Biologic License Application (BLA) 761473 for NUFYMCO (ranibizumab-leyk) submitted by FORMYCON AG. The approval covers two strengths of the injectable drug: 6mg/mL and 10mg/mL. This action signifies the FDA's authorization for this new biosimilar product to be marketed in the United States.

This approval is an informational notice regarding a new drug product. While it does not impose immediate new compliance obligations on most entities, pharmaceutical companies and drug manufacturers should be aware of this new market entrant. No specific compliance deadlines or penalties are associated with this approval notice itself.

Source document (simplified)

Home | Previous Page

Biologic License Application (BLA): 761473
Company: FORMYCON AG
- Email

Products on BLA 761473

| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
| --- | --- | --- | --- | --- | --- | --- | --- |
| NUFYMCO | RANIBIZUMAB-LEYK | 6MG/ML | INJECTION | Prescription | None | No | No |
| NUFYMCO | RANIBIZUMAB-LEYK | 10MG/ML | INJECTION | Prescription | None | No | No |

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761473

Original Approvals or Tentative Approvals

| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12/18/2025 | ORIG-1 | Approval | | N/A | Letter (PDF) | Label is not available on this site. | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761473Orig1s000ltr.pdf |

Related changes

Favicon for www.fda.gov Lidl US Recalls Chocolate Ladybugs Due to Undeclared Hazelnut
Priority review Mar 13, 2026 • FDA Recalls & Safety Alerts • Government
Favicon for www.fda.gov Insulet Recalls Omnipod 5 Pods Due to Manufacturing Issue
Urgent Mar 13, 2026 • FDA Recalls & Safety Alerts • Government
Favicon for www.fda.gov FDA Drug Shortage Update
Routine Mar 13, 2026 • FDA Drug Shortages • Drug Safety
Favicon for www.bfarm.de Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit
Priority review Mar 13, 2026 • BfArM Drug Safety Communications • Drug Safety
Favicon for www.aifa.gov.it PRAC Recommendations on Safety Signals
Priority review Mar 13, 2026 • AIFA Drug Safety Signals • Drug Safety
Favicon for www.aifa.gov.it PRAC Recommendations on Signals - January 2026 Meeting
Priority review Mar 13, 2026 • AIFA Drug Safety Signals • Drug Safety

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
December 18th, 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

Get Drug Safety alerts

Weekly digest. AI-summarized, no noise.

Free. Unsubscribe anytime.

Get alerts for this source

We'll email you when FDA Biosimilar Product Approvals publishes new changes.

Free. Unsubscribe anytime.