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Market Analysis and Price Projections for NDC 50742-0395
Last updated: March 12, 2026
What is NDC 50742-0395?
NDC 50742-0395 identifies Cemiplimab-rwlc (Libtayo), a PD-1 inhibitor developed by Regeneron Pharmaceuticals. Approved by the FDA in 2018, it is indicated for cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and certain non-small cell lung cancers (NSCLC). It is administered as an intravenous infusion.
Market Overview
Market Size and Demand Drivers
Indications:
Approved for locally advanced or metastatic CSCC (FDA 2018)
Approved for BCC post Hedgehog inhibitor therapy (FDA 2020)
Approved for NSCLC with progression on platinum-based chemotherapy (FDA 2021)
Market Potential:
The global skin cancer market was valued at USD 1.2 billion in 2020.
The PD-1/PD-L1 inhibitors market ranked approximately USD 20 billion in 2022.
Partnership or licensing deals for emerging markets.
Summary
Aspect
Details
Current Price
USD 15,000+ per dose (AWP)
Market Size (2022)
Approx. USD 1.2 billion for skin cancer indications; global PD-1 market at USD 20 billion
Forecast (2023-2028)
USD 16,000 – USD 17,500 per dose; potential pricing plateau before biosimilar entry
Patent Expiry
Around 2030, after which biosimilars may reduce prices significantly
Key Takeaways
NDC 50742-0395 (Cemiplimab-rwlc) is a leading immunotherapy for specific skin cancers and NSCLC.
Market demand is increasing, primarily driven by the expanding indications.
Prices are stable currently, with potential for incremental growth until patent expiration.
Post-patent, biosimilar competition is expected to drive prices downward.
Market growth is contingent on new indications, insurance reimbursement policies, and biosimilar entry.
FAQs
What are the main indications for Cemiplimab-rwlc?
Locally advanced or metastatic cutaneous squamous cell carcinoma, basal cell carcinoma after Hedgehog inhibitor failure, and certain NSCLCs.
How does the price of Cemiplimab compare to competitors?
It is priced similarly to other PD-1 inhibitors like Pembrolizumab, with an average of USD 15,000 per dose.
When are biosimilars likely to enter the market?
Patent expiration is projected around 2030, with biosperical development potentially starting 2-3 years prior.
What factors could impact future pricing?
Patent expiration, indication expansion, regulatory policy changes, and biosimilar competition.
What market trends support continued demand for Cemiplimab?
Rising prevalence of skin cancers and expansion into NSCLC, coupled with limited current biosimilar competition.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] U.S. Food and Drug Administration. (2018). FDA approves first immunotherapy for advanced CSCC.
[3] Regeneron Pharmaceuticals. (2022). Libtayo prescribing information.
[4] MarketWatch. (2022). PD-1/PD-L1 inhibitors market size and forecast.
[5] Evaluate Pharma. (2022). Biologics pricing and market trends analysis.
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