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
University of Chicago	PHASE2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	PHASE2
Jiangsu HengRui Medicine Co., Ltd.	PHASE3

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

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

International Patents for pertuzumab

Country	Patent Number	Estimated Expiration
Chile	2015003049
Argentina	095863
South Korea	20150083139
European Patent Office	2112167

Supplementary Protection Certificates for pertuzumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CR 2013 00013	Denmark		PRODUCT NAME: PERTUZUMAB; REG. NO/DATE: EU/1/13/813/001 20130304
92164	Luxembourg		PRODUCT NAME: PERTUZUMAB
C300580	Netherlands		PRODUCT NAME: PERTUZUMAB; REGISTRATION NO/DATE: EU/1/13/813/001 20130304
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

Market Dynamics and Financial Trajectory for the Biologic Drug: Pertuzumab

Last updated: July 28, 2025

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Introduction

Pertuzumab, marketed under the brand name Perjeta, is a monoclonal antibody targeting HER2-positive breast cancer. Approved initially by the U.S. Food and Drug Administration (FDA) in 2012, pertuzumab has become a cornerstone in targeted breast cancer therapy, especially for early-stage and metastatic HER2-positive tumors. Its market trajectory reflects evolving clinical practices, competitive dynamics within oncology biologics, and broader healthcare trends toward personalized medicine. This analysis delineates the key drivers shaping pertuzumab’s market dynamics and forecasts its financial potential within the expanding biologic landscape.

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Market Overview and Clinical Foundations

Pertuzumab synergizes with trastuzumab, another HER2-targeted agent, to enhance antitumor effects through complementary mechanisms—pertuzumab inhibits HER2 dimerization, while trastuzumab mediates immune responses. The combination’s landmark studies, notably the CLEOPATRA trial, demonstrated significant improvements in overall survival for metastatic HER2-positive breast cancer, reinforcing its therapeutic importance (1).

The global breast cancer treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, driven by rising incidence, heightened screening programs, and advances in molecular diagnostics. Biologics like pertuzumab represent a significant, high-value segment within this broader market, accounting for a substantial proportion of treatment expenditure.

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Market Dynamics Influencing Pertuzumab

1. Expanding Indications and Line Extensions

Initially approved for metastatic HER2-positive breast cancer, pertuzumab’s label expanded to include neoadjuvant and adjuvant settings, notably with the FDA’s 2019 approval for early-stage breast cancer combining it with trastuzumab and chemotherapy (2). These indications drastically enlarge potential patient populations and revenue streams.

Clinical trials such as APHINITY and Feasibility studies continue exploring pertuzumab in other HER2-driven cancers, including gastric and esophageal cancers. Broader indications, pending regulatory approvals, could further catalyze sales growth.

2. Competitive Landscape

Pertuzumab faces competition primarily from trastuzumab, which has a longer market history and biosimilars, and other emerging HER2-targeted agents like tucatinib and margetuximab. Biosimilars of trastuzumab, introduced globally since 2018, exert downward pressure on biologic pricing, thereby impacting pertuzumab’s profit margins (3).

Furthermore, the advent of antibody-drug conjugates (ADCs), such as trastuzumab deruxtecan (Enhertu), offers alternative treatment pathways that could influence pertuzumab’s usage, especially in later-line settings.

3. Pricing and Reimbursement Policies

Pricing strategies significantly influence pertuzumab’s market uptake. In regions with higher healthcare expenditure and supportive reimbursement frameworks—such as the U.S. and Europe—pertuzumab maintains premium pricing, justified by its clinical benefits. Conversely, price negotiations and cost-effectiveness assessments in countries like Japan and Canada bolster biosimilar competition and restrict market expansion.

Value-based pricing models, emphasizing improved survival and quality of life, are increasingly adopted to justify premium prices. Patient access programs and discount arrangements further shape market penetration.

4. Manufacturing, Patent Protection, and Biosimilar Dynamics

Pertuzumab’s patent protections, initially expiring around 2027, are subject to patent challenges and biosimilar entry timelines. Biosimilar manufacturers are actively developing pertuzumab equivalents, targeting markets where patents have lapsed or are close to expiry (4). The entry of biosimilars could lead to substantial pricing erosion but also expand access, especially in price-sensitive markets.

5. Impact of Healthcare Trends and Personalized Medicine

The shift toward precision oncology underscores the demand for biomarker-driven therapies like pertuzumab. Companion diagnostics for HER2 status are crucial for selecting appropriate patients, thereby optimizing therapeutic outcomes and healthcare resource utilization. As diagnostic accuracy and accessibility improve, pertuzumab’s targeted deployment enhances its adoption and clinical value.

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Financial Trajectory and Forecasts

Current Revenue Performance

Pfizer, the primary manufacturer of pertuzumab, reported global sales in the range of $1.2 billion in 2022, with growth driven by expanded indications and geographic penetration (5). The U.S. remains the largest market, accounting for approximately 60% of revenues, supported by high reimbursement rates and clinical adoption.

Profit margins are influenced by manufacturing complexity, pricing strategies, and competition from biosimilars. Overall, pertuzumab contributes a significant share to Pfizer’s oncology portfolio, reinforcing its strategic importance.

Projected Growth Outlook

Analysts project continued growth for pertuzumab, with CAGR estimates varying between 7-10% over the next five years. Key factors include:

• Market Expansion: Broader indications in adjuvant settings and minimally invasive diagnostics expanding eligible populations.

• Geographic Penetration: Emerging markets such as China and India are adopting newer biologics rapidly, particularly as biosimilar options lower prices.

• Regulatory Advances: Approvals of biosimilars and potential new formulations (e.g., subcutaneous injection) may influence market share distribution.

• Clinical Evidence: Ongoing trials examining pertuzumab in other HER2-positive cancers could unlock new revenue streams, especially if positive outcomes translate into regulatory approvals.

Pricing and Cost-Effectiveness Considerations

In developed markets, high drug costs are balanced against substantial clinical benefits, justifying premium pricing. However, increased biosimilar competition and healthcare policies prioritizing cost containment are expected to pressure prices downward, potentially reducing per-unit revenue but increasing volume sales.

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Market Challenges and Opportunities

Challenges:

• Biosimilar Competition: The emergence of biosimilars, particularly in Europe and Asia, threatens to commoditize pertuzumab, impacting revenue streams.
• Pricing Pressures: Payer-driven cost containment initiatives could limit growth, especially in non-U.S. markets.
• Therapeutic Competition: Newly approved HER2-targeted agents may supplant pertuzumab in some indications.

Opportunities:

• Expanding Indications: The exploration of pertuzumab in other HER2-driven cancers enhances its commercial footprint.
• Combination Strategies: Partnered or combination regimens with ADCs or immune checkpoint inhibitors could create new growth avenues.
• Personalized Medicine: Advances in diagnostics facilitate targeted patient selection, maximizing treatment efficacy and boosting drug value.

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Conclusion

Pertuzumab’s market prospects are shaped by a complex interplay of clinical advancements, competitive forces, regulatory landscapes, and healthcare policy shifts. While biosimilar competition and pricing pressures challenge near-term growth, expanding indications, strategic partnerships, and a sustained focus on personalized medicine position pertuzumab as a vital player in the biologic oncology arena. In the coming years, its financial trajectory will hinge on how effectively its manufacturers address these dynamics while innovating within the evolving landscape of targeted cancer treatment.

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Key Takeaways

• Pertuzumab experienced rapid adoption driven by robust clinical trial data and expanding indications.
• Biosimilar entry and increasing price competition present significant challenges, potentially eroding margins.
• Broader labeling in early-stage and combination settings offers substantial upside potential.
• Strategic expansion into emerging markets and other HER2-positive cancers can bolster revenues.
• Careful navigation of healthcare reimbursement policies and continued innovation are critical to sustaining financial growth.

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FAQs

1. When is pertuzumab likely to face biosimilar competition globally?
Biosimilar development is advancing, with some regions like Europe approving pertuzumab biosimilars as early as 2023. Patent expirations around 2027 facilitate biosimilar market entry, potentially starting in Europe and Asia before North America.

2. How does pertuzumab compare to other HER2-targeted therapies in terms of efficacy?
Clinical trials demonstrate that the combination of pertuzumab and trastuzumab significantly improves overall survival and progression-free survival compared to trastuzumab alone, establishing it as a superior regimen for HER2-positive breast cancer.

3. What are the primary markets driving pertuzumab sales?
The United States leads, followed by Europe, Japan, and emerging markets such as China and India. These regions show growing adoption driven by healthcare infrastructure, diagnostic access, and reimbursement policies.

4. Are there any new formulations of pertuzumab under development?
Yes, subcutaneous formulations are in late-stage development, aiming to improve administration convenience and reduce infusion times, potentially expanding patient and clinician acceptance.

5. What can manufacturers do to extend pertuzumab’s market lifespan?
Investing in new indications, combination therapies, companion diagnostics, and optimizing biosimilar strategies can prolong the drug's commercial relevance in a competitive environment.

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Sources:
[1] Swain, S. M., et al. (2015). "Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer." The New England Journal of Medicine.
[2] FDA Approval Letter for Pertuzumab (2019).
[3] IQVIA, Global Oncology Market Insights, 2022.
[4] Biosimilar Development Reports, 2023.
[5] Pfizer Annual Report, 2022.