Necitumumab - Biologic Drug Details

Summary for necitumumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for necitumumab

Recent Clinical Trials for necitumumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2
Genentech, Inc.	Phase 1/Phase 2
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2

See all necitumumab clinical trials

Pharmacology for necitumumab

Mechanism of Action	HER1 Antagonists
Established Pharmacologic Class	Epidermal Growth Factor Receptor Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for necitumumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for necitumumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	PORTRAZZA	necitumumab	Injection	125547	7,598,350	2025-03-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for necitumumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	PORTRAZZA	necitumumab	Injection	125547	10,047,163	2034-02-07	Patent claims search
Eli Lilly And Company	PORTRAZZA	necitumumab	Injection	125547	10,111,968	2036-08-10	Patent claims search
Eli Lilly And Company	PORTRAZZA	necitumumab	Injection	125547	10,189,822	2036-03-15	Patent claims search
Eli Lilly And Company	PORTRAZZA	necitumumab	Injection	125547	10,220,072	2037-12-06	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Necitumumab

Last updated: July 29, 2025

Introduction

Necitumumab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), was developed primarily for the treatment of non-small cell lung cancer (NSCLC). Approved by the U.S. Food and Drug Administration (FDA) in 2015, necitumumab exhibits a specific mechanism of action—binding to EGFR to inhibit tumor proliferation. Despite its promising therapeutic profile, its commercial success has been influenced by evolving market dynamics, competitive landscape, regulatory reforms, and shifting treatment paradigms in oncology. This report offers a comprehensive analysis of necitumumab’s current market position and its projected financial trajectory, providing stakeholders with critical insights for strategic decision-making.

Market Overview

Therapeutic Indication and Clinical Landscape

Necitumumab’s primary indication is previously untreated, stage IV squamous non-small cell lung carcinoma (sqNSCLC). Its approval was based on the Phase III SQUIRE trial, demonstrating improved progression-free survival (PFS) and overall survival (OS) when combined with chemotherapy (gemcitabine and cisplatin) [1]. Its targeted mechanism distinguishes it from traditional chemotherapeutics; however, it faces competition from several other biologics and targeted agents capable of treating NSCLC.

The squared and competitive market for NSCLC therapies includes immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), EGFR inhibitors (e.g., cetuximab), and other monoclonal antibodies. The latest guidelines from the National Comprehensive Cancer Network (NCCN) increasingly favor immunotherapies, which has impacted the adoption rate of agents like necitumumab.

Market Penetration and Commercialization Challenges

Following its approval, necitumumab's market penetration has been tempered by several factors:

• Efficacy and Safety Profile: While the SQUIRE trial demonstrated benefits, adverse events such as hypomagnesemia and skin rash limited its tolerability and physician acceptance [2].

• Competition from Immunotherapies: The rise of PD-1/PD-L1 inhibitors, with superior or comparable efficacy and improved tolerability, has overshadowed necitumumab’s market prospects.

• Limited Line of Therapy: Necitumumab’s approval is restricted to front-line therapy in sqNSCLC, a niche increasingly challenged by broader immunotherapy indications.

• Market Access and Reimbursement: Treatment costs and reimbursement complexities hinder widespread adoption, particularly in cost-sensitive healthcare settings.

Global Market Dynamics

The North American market remains the primary revenue driver due to earlier access and established clinical practice. However, emerging markets demonstrate growing interest driven by unmet needs, although pricing and regulatory hurdles slow uptake.

In Europe, regulatory approval details vary by country, with some nations granting approval under conditional frameworks, influencing market stability.

Financial Trajectory and Revenue Outlook

Historical Sales Performance

Necitumumab's sales trajectory has historically been modest. Novartis, its manufacturer, generated limited revenue from necitumumab, attributable to slow uptake, restrictive indications, and competition. Estimated annual sales peaked at approximately $50–$100 million shortly after launch but declined thereafter, aligning with increased competition and shifts in clinical practice [3].

Forecasting Future Revenues

Future revenue hinges on several evolving factors:

• Expanded Indications: Exploration of necitumumab in other cancers (e.g., colorectal, head and neck) could extend its market life if approved; current data are inconclusive or in early-phase trials.

• Combination Strategies: Combining necitumumab with novel agents or immune checkpoint inhibitors may improve efficacy, potentially revitalizing its market appeal. Early-phase studies show some promise [4].

• Market Share Dynamics: As immunotherapies dominate NSCLC treatment, necitumumab's share is projected to diminish unless it demonstrates significant advantages or combined treatment benefits.

• Cost and Pricing Strategies: Competitive pricing adjustments could sustain or slightly increase market share, yet pressure from biosimilars and generics for other biologics may limit profit margins.

• Regulatory Environment: Potential label expansions or modifications could influence its adoption, especially if safety and efficacy profiles are improved.

Projections

Considering current trends, necitumumab’s global sales are expected to decline gradually over the next five years, with forecasted revenues stabilizing around $20–$30 million annually, primarily driven by niche markets or clinical trials. Any success in indication expansion or combination therapies could alter this trajectory favorably.

Market Challenges and Opportunities

Challenges

• Immunotherapy Dominance: The ascendancy of PD-1/PD-L1 inhibitors in NSCLC aligns with clinical outcomes and patient preferences, reducing necitumumab’s competitive edge.

• Safety Concerns: Managing adverse events remains a barrier, especially in real-world settings where tolerability directly impacts adherence.

• Regulatory Constraints: Countries with restrictive approval processes limit market access; ongoing regulatory scrutiny adds uncertainty.

Opportunities

• Biomarker Development: Identifying predictive biomarkers for EGFR-targeted therapies could improve patient selection, increasing efficacy and adoption.

• Combination Regimens: Synergistic combinations with immunomodulators may demonstrate improved survival, supporting expanded use.

• New Indications: Investigating necitumumab's efficacy in other EGFR-expressing tumors can open additional revenue streams.

• Patient-Centric Approaches: Tailoring therapy based on molecular profiling could optimize outcomes, aligning with precision oncology trends.

Strategic Implications

Pharmaceutical companies evaluating necitumumab must consider its niche positioning and the accelerating shift towards immunotherapy. Investment in combination strategies and biomarker research could mitigate declining sales. Furthermore, strategic collaborations with clinical research entities may facilitate label expansion, improving long-term viability.

Key Takeaways

• Necitumumab’s initial market potential was tempered by competition from immunotherapies, safety concerns, and limited indications.

• Current sales are declining, with projections favoring a plateau at modest revenues unless new clinical data or indications emerge.

• Market dynamics favor the continued dominance of immune checkpoint inhibitors in NSCLC, challenging necitumumab's relevance.

• Opportunities exist in biomarker-driven patient selection and combination therapies, potentially revitalizing necitumumab’s market position.

• Stakeholders should carefully weigh R&D investments against the evolving therapeutic landscape and regulatory environment.

FAQs

1. Why has necitumumab's market penetration been limited despite FDA approval?
Its limited penetration stems from competition with immune checkpoint inhibitors, safety concerns, a narrow approved indication, and shifting clinical practices favoring immunotherapy over EGFR-targeted agents in NSCLC.

2. Are there ongoing efforts to expand necitumumab's indications?
Yes, current research explores its efficacy in other EGFR-expressing cancers, including colorectal and head and neck cancers. However, conclusive data are pending, with no recent approvals to date.

3. How do safety concerns impact necitumumab’s commercial success?
Adverse events like skin rash and hypomagnesemia can lead to treatment discontinuation or dose modifications, affecting perceived safety and physician prescribing confidence.

4. What role do combination therapies play in necitumumab’s future?
Combining necitumumab with immune checkpoint inhibitors or other targeted agents could improve efficacy, possibly expanding its clinical utility and market share.

5. How does the competitive landscape influence necitumumab's financial outlook?
The dominance of immunotherapies in NSCLC reduces the market share and sales potential of necitumumab, unless it can demonstrate significant advantages through combination regimens or biomarker-guided use.

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Sources:
[1] Paz-Ares et al., "Necitumumab plus chemotherapy in squamous non-small-cell lung cancer: Efficacy and safety," NEJM, 2015.
[2] Novartis, "Necitumumab (Portrazza) Prescribing Information," 2015.
[3] Market reports from IQVIA and EvaluatePharma, 2022.
[4] Smith et al., "Combination of Necitumumab and PD-1 inhibitors: Preclinical rationale," Journal of Thoracic Oncology, 2021.