Pertuzumab - Biologic Drug Details

Summary for pertuzumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for pertuzumab

Recent Clinical Trials for pertuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai Henlius Biotech	PHASE2
University of Chicago	PHASE2
Xijing Hospital	PHASE2

See all pertuzumab clinical trials

Pharmacology for pertuzumab

Mechanism of Action	HER2/Neu/cerbB2 Antagonists
Established Pharmacologic Class	HER2/neu 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 pertuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pertuzumab 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
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2038-01-16	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2007-11-06	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2015-06-23	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2021-03-14	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2020-11-02	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2025-06-15	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2026-05-05	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pertuzumab 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
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2037-01-05	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2036-12-20	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2037-07-18	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2035-05-11	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2035-11-20	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2036-06-24	Patent claims search
Genentech, Inc.	PERJETA	pertuzumab	Injection	125409		2034-02-07	Patent claims search

International Patents for pertuzumab

Country	Patent Number	Estimated Expiration
New Zealand	556095
Mexico	2020008977
Israel	146954
European Patent Office	4119583
Norway	2013005
Argentina	024464
World Intellectual Property Organization (WIPO)	0100244

Supplementary Protection Certificates for pertuzumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
480	Finland
C 2013 009	Romania		PRODUCT NAME: PERTUZUMAB; NATIONAL AUTHORISATION NUMBER: RO EU/1/13/813/001; DATE OF NATIONAL AUTHOR01; DATE OF FIRST AUTHORISATION IN EEA: 20130304 ISATION: 20130304; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/13/813/0
300580	Netherlands		PRODUCT NAME: PERTUZUMAB; REGISTRATION NO/DATE: EU/1/13/813/001 20130304
PA2013006,C1189641	Lithuania		PRODUCT NAME: PERTUZUMABUM; REGISTRATION NO/DATE: EU/1/13/813/001 20130304
CA 2013 00013	Denmark
C01189641/01	Switzerland		PRODUCT NAME: PERTUZUMAB; REG. NO/DATE: SWISSMEDIC 62510 20120813
92164	Luxembourg		PRODUCT NAME: PERTUZUMAB

Market Dynamics and Financial Trajectory for Pertuzumab

Last updated: February 13, 2026

Overview:
Pertuzumab, marketed as Perjeta by Roche, is a monoclonal antibody targeting the HER2 receptor. Approved by the FDA in 2012 for HER2-positive breast cancer, it has expanded into extensive oncology indications, contributing to its revenue growth. Its market performance is influenced by patent lifespan, competition, regulatory status, and clinical adoption.

Market Size and Growth:
The global HER2-positive breast cancer treatment market was valued at approximately $4.2 billion in 2022. Projected compound annual growth rate (CAGR) from 2023 to 2028 stands at 8%, driven by increased diagnosis rates, longer survival, and expanding indications.

Key Revenue Drivers:

• Primary use in early and metastatic HER2-positive breast cancer, including neoadjuvant, adjuvant, and metastatic settings.
• Expansion into gastric and gastroesophageal cancers; FDA approved for HER2-positive gastric cancer in 2019.
• Combination therapies with trastuzumab and chemotherapy increase patient uptake.

Revenue Trends:
Roche reported sales of Perjeta at CHF 2.584 billion (~$2.8 billion) in 2022, up from CHF 2.1 billion (~$2.3 billion) in 2021. Growth is attributed to increased penetration in developed markets and approval expansions.

Patent and Market Exclusivity:

• Patent expiration set for 2025 in key markets like the US and EU.
• Patent challenges and biosimilar entries expected thereafter, pressuring prices and sales volume.

Competition and Biosimilars:

• Margetuximab (retail name: Margenza), a HER2-targeting monoclonal antibody, received FDA approval in 2020, offering a potential alternative.
• Biosimilar development for trastuzumab (Herceptin), authorized in 2018, threatens combined HER2-targeted therapy market share.
• No biosimilars currently approved specifically for pertuzumab, but biosimilar entries for HER2 inhibitors are imminent.

Pricing and Reimbursement:

• Price per treatment course in the US ranges from $10,000 to $15,000, depending on regimen and indication.
• Payor negotiations and reimbursement policies in major markets impact revenue retention, with price controls in effect in some countries.

Regulatory and Clinical Pipeline:

• Ongoing trials explore pertuzumab in adjuvant settings, triple-negative breast cancer, and other HER2-expressing tumors.
• Regulatory approvals in new indications could extend revenue streams; delay or denial could hinder growth.

Financial Outlook:

• Roche anticipates stable growth until patent expiry, followed by price erosion and pipeline reliance.
• Biosimilar competition might reduce peak sales by 20-30% post-2025.
• Company investments focus on combination regimens and early-stage trials to sustain revenue.

Risks and Challenges:

• Patent cliff anticipated in 2025.
• Biosimilar and generic entry could impact profit margins.
• Competitive landscape includes newer agents targeting HER2, such as trastuzumab deruxtecan, with promising efficacy data.

Summary Table

Aspect	Data Points
2022 Revenue	CHF 2.584 billion (~$2.8 billion)
Market Size (2022)	~$4.2 billion
CAGR (2023-2028)	8%
Patent Expiry	2025 in US/EU
Price Per Treatment	$10,000–$15,000
Biosimilar Competition	Entry expected post-2025; biosimilars for trastuzumab active since 2018
FDA Approvals	2012 (breast cancer), 2019 (gastric cancer)
Key Indications	HER2-positive breast and gastric cancers

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Key Takeaways

• Revenue growth driven by expanded indications and market penetration but faces patent expiration risk in 2025.
• Competition from biosimilars and new targeted agents could reduce revenue by 20-30%.
• Clinical trials expanding pertuzumab applications could open new revenue pathways.
• Pricing policies and reimbursement landscape significantly influence profitability.
• Roche’s focus on combination therapies and pipeline development aims to offset patent cliffs and competitive pressures.

FAQs

1. How will biosimilar competition impact pertuzumab sales after patent expiry?
Biosimilars for trastuzumab launched in 2018, affecting the combined HER2 therapy market. Biosimilars for pertuzumab are expected after 2025. Sales could decline by 20-30% depending on market penetration and pricing strategies.

2. Are there any regulatory hurdles affecting pertuzumab’s market?
Regulatory delays or denials in expanded indications could restrict growth. Approved indications in breast and gastric cancers provide stable revenue, but future approvals require robust clinical trial data.

3. What are the key clinical developments that could influence pertuzumab’s market?
Ongoing trials in adjuvant and early-stage settings, as well as combination regimens with emerging therapies, could extend its use and revenues if successful.

4. How does competitive landscape influence pertuzumab’s pricing?
New agents like trastuzumab deruxtecan have demonstrated high efficacy, pressuring pertuzumab pricing. Biosimilars will further drive price reductions to maintain market share.

5. What strategies can Roche employ to sustain pertuzumab’s revenue?
Investments in pipeline expansion, exploring new indications, strategic pricing, and early adoption in combination therapies are key.

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Sources:

[1] Roche Annual Report 2022.
[2] Evaluate Pharma, 2023 Market Reports.
[3] FDA Product Approvals and Indications Database.
[4] MarketWatch, Oncology Therapeutics Reports, 2023.
[5] Biosimilar Hematology & Oncology: Strategic Entry and Market Impact, Biosimilar Development News, 2022.