Prescription medicine
Cemiplimab Brand names: Libtayo
Cemiplimab (Libtayo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cemiplimab FDA label on DailyMed (effective August 31, 2026); every cemiplimab label on DailyMed.
Highlights of the record
FDA label of August 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
Forms and strengths
- 50 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest July 28, 2026
- FAERS reports
- 2,008 through July 30, 2026
What is cemiplimab used for?
From the label: indications and usageLIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. ( 1.1 ) for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation. ( 1.1 , 14.1 ) Basal Cell Carcinoma (BCC) for the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. […]
Conditions named in the indications of cemiplimab's FDA labels, with every medicine labeled for each:
From other cemiplimab labelsLung cancer: … for whom a hedgehog pathway inhibitor is not appropriate. ( 1.2 ) Non-Small Cell Lung Cancer (NSCLC) in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung cancer (NSCLC) …
Source: FDA drug label (LIBTAYO), Regeneron Pharmaceuticals, Inc., effective August 31, 2026 (SPL set 4347ae1f-d397-4f18-8b70-03897e1c054a), via openFDA; the full label on DailyMed
What does the patient leaflet for cemiplimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LIBTAYO?LIBTAYO is a medicine that may treat certain types of cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. […] These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. […]
Source: FDA drug label (LIBTAYO), Regeneron Pharmaceuticals, Inc., effective August 31, 2026 (SPL set 4347ae1f-d397-4f18-8b70-03897e1c054a), via openFDA; the full label on DailyMed
Is there a generic for cemiplimab (Libtayo)?
No generic cemiplimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cemiplimab been recalled?
The FDA's Enforcement Report lists 1 recall naming cemiplimab since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 28, 2026 | Class II | Regeneron Pharmaceuticals Inc | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cemiplimab label say about other medicines?
The cemiplimab label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Prednisone | warnings and precautions | In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
Source: FDA drug label (LIBTAYO), Regeneron Pharmaceuticals, Inc., effective August 31, 2026 (SPL set 4347ae1f-d397-4f18-8b70-03897e1c054a), via openFDA; the full label on DailyMed
What do FAERS reports show for cemiplimab?
The FDA Adverse Event Reporting System holds 2,008 reports that list cemiplimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 418 are coded as a death and 571 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cemiplimab?
16 other medicines are given the same way (intravenous) and in the same FDA class as cemiplimab or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as cemiplimab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cemiplimab
- 16 medicines for the same use
- Cemiplimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other