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Libtayo

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Libtayo

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Libtayo
Generic Name (API): Cemiplimab
Dosage Form & Strength: 350 mg/7 mL (50 mg/ml)
Route: Intravenous
Drug Class: PD-1 (programmed death receptor-1) blocking antibody, immune checkpoint inhibitor

Manufacturer / Innovator:

USA

Regulatory Approval:

  • FDA-approved for metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) not eligible for curative surgery or radiation; adjuvant treatment of CSCC at high risk of recurrence after surgery and radiation; locally advanced basal cell carcino
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  • Medicines sourced from authorized manufacturers with full batch traceability

    Medicines sourced from authorized manufacturers with full batch traceability.

  • EU-GDP Compliant Warehousing for secure, quality-controlled global distribution.

    EU-GDP compliant warehousing for secure, quality-controlled global distribution.

  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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Understanding Libtayo (Cemiplimab-rwlc) and Its Medical Uses

Libtayo (cemiplimab-rwlc) is a PD-1 blocking antibody used across several skin cancers and non-small cell lung cancer, helping the immune system recognize and attack tumor cells.

Approved Indications

Libtayo is FDA-approved for metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) not eligible for curative surgery or radiation, and for adjuvant treatment of CSCC at high risk of recurrence after surgery and radiation. It is also approved for locally advanced basal cell carcinoma previously treated with (or not appropriate for) a hedgehog pathway inhibitor, and for first-line NSCLC, either alone in tumors with high PD-L1 expression or combined with platinum-based chemotherapy.

How It Works

Cemiplimab binds to PD-1 receptors on T-cells, blocking their interaction with PD-L1/PD-L2 on tumor cells, restoring the immune system's ability to identify and destroy cancer cells.

Dosing

The typical dose is 350 mg by intravenous infusion every 3 weeks, or 700 mg every 6 weeks for certain indications, continued until disease progression or unacceptable toxicity, as determined by the treating oncologist.

Warnings and Precautions for Libtayo

As a PD-1 immune checkpoint inhibitor, Libtayo can cause immune-mediated adverse reactions affecting multiple organ systems, which may be severe or fatal and can occur even after treatment discontinuation.

Immune-Mediated Pneumonitis

Monitor for new or worsening respiratory symptoms; manage with corticosteroids and treatment interruption as needed.

Immune-Mediated Colitis

Monitor for diarrhea or signs of colitis.

Immune-Mediated Hepatitis and Endocrinopathies

Monitor liver function tests and thyroid/adrenal hormone levels periodically; adrenal insufficiency has been reported.

Immune-Mediated Nephritis and Skin Reactions

Monitor kidney function and for skin changes throughout treatment.

Infusion-Related Reactions

Monitor during and after infusion for hypersensitivity reactions.

Embryo-Fetal Toxicity

Libtayo can cause fetal harm. Effective contraception is required during treatment and for a defined period after the final dose.

  • Immune-mediated reactions can occur even after treatment ends — report new symptoms promptly, even after finishing therapy.
  • Regular monitoring of organ function is required throughout treatment.
  • Follow the combination-therapy monitoring schedule when used with chemotherapy for NSCLC.

How to Access Libtayo in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Libtayo

Libtayo (cemiplimab-rwlc) is manufactured by Regeneron Pharmaceuticals and co-marketed with Sanofi, approved across cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer.

Documentation Required

Import of Libtayo through a Named Patient Program requires a valid prescription from the treating oncologist, diagnosis and treatment history documentation, and supporting clinical documentation as required by Indian regulatory authorities.

Sourcing

NPP sources Libtayo directly from Regeneron's authorized supply chain to ensure product authenticity and regulatory compliance.

Sourcing and Delivery of Libtayo

Libtayo is sourced through verified, GDP-compliant, cold-chain channels from Regeneron's authorized supply chain to ensure authenticity and quality.

Storage Requirements

Libtayo should be stored refrigerated at 2°C to 8°C. Do not freeze.

Delivery Process

Once sourced, Libtayo is packed and transported under continuous cold-chain conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.

Availability of Libtayo Across Major Cities in India

Patients across India can access Libtayo through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.

Mumbai

Leading oncology centers in Mumbai support skin cancer and lung cancer treatment coordination for Libtayo access.

Delhi

Delhi's major cancer hospitals assist patients with treatment planning and prescription support for Libtayo.

Bangalore

Bangalore's oncology network offers access to Libtayo for eligible patients.

Chennai

Chennai-based specialists coordinate Libtayo access alongside comprehensive cancer care.

Hyderabad

Hyderabad's cancer care institutions support patients pursuing Libtayo therapy.

Kolkata

Kolkata's oncology centers help coordinate documentation and treatment access for Libtayo.

Pune

Pune-based oncologists assist with treatment planning for Libtayo.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Libtayo.

Kochi

Kochi's oncology units assist patients with the documentation needed for Libtayo access.

Chandigarh

Chandigarh's cancer care centers support Libtayo treatment coordination for patients from North India.

Jaipur

Jaipur's oncology specialists help patients navigate the Libtayo access process.

Lucknow

Lucknow-based cancer centers assist patients pursuing Libtayo therapy.

Bhubaneswar

Bhubaneswar's oncology institutions support access to Libtayo for eligible patients.

Guwahati

Guwahati's specialists help coordinate Libtayo access for patients across the Northeast.

Patients in other cities across India can also access Libtayo through NPP's nationwide coordination network.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 10 September 2026
Sources: FDA • CDSCO

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 10 September 2026

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