Evolocumab - Biologic Drug Details

Summary for evolocumab

Tradenames:	1
High Confidence Patents:	11
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for evolocumab

Recent Clinical Trials for evolocumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Jining First People's Hospital	PHASE4
Peking Union Medical College Hospital	PHASE4
First Affiliated Hospital of Harbin Medical University	PHASE4

See all evolocumab clinical trials

Pharmacology for evolocumab

Mechanism of Action	PCSK9 Inhibitors
Established Pharmacologic Class	PCSK9 Inhibitor
Chemical Structure	Antibodies, Monoclonal

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 evolocumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for evolocumab 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
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2028-08-22	DrugPatentWatch analysis and company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2029-05-28	DrugPatentWatch analysis and company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2033-04-10	DrugPatentWatch analysis and company disclosures
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2034-04-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for evolocumab 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
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2037-05-22	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2038-06-21	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2038-06-13	Patent claims search
Amgen Inc.	REPATHA	evolocumab	Injection	125522		2037-07-13	Patent claims search

International Patents for evolocumab

Country	Patent Number	Estimated Expiration
European Patent Office	2615113
South Korea	20210028741
South Korea	101702194
Japan	6638009

Supplementary Protection Certificates for evolocumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
16C0025	France		PRODUCT NAME: EVOLOCUMAB; REGISTRATION NO/DATE: EU/1/15/1016 20150721
2016/025	Ireland		PRODUCT NAME: EVOLOCUMAB; NAT REGISTRATION NO/DATE: EU/1/15/1016/001 - EU/1/15/1016/005 20150717;
C20160021	Estonia		;REG NO/DATE: EU/1/15/1016 21.07.2015; NATIONAL AUTHORISATION NUMBER: EMA/690314/2022 15.09.2022
1690035-9	Sweden		PRODUCT NAME: ALIROKUMAB; REG. NO/DATE: EU/1/15/1031 20150925

Market Dynamics and Financial Trajectory for the Biologic Drug: Evolocumab

Last updated: September 23, 2025

Introduction

Evolocumab, marketed under the brand name Repatha, is a monoclonal antibody developed by Amgen for the treatment of hypercholesterolemia and cardiovascular risk reduction. As a PCSK9 inhibitor, evolocumab has revolutionized lipid management, offering a new therapeutic paradigm for patients with high LDL cholesterol levels, especially those who are statin-intolerant or inadequately controlled with traditional therapies. This report provides an in-depth analysis of evolocumab's market dynamics and financial trajectory, highlighting key factors shaping its commercial performance and future outlook.

Market Overview

The global market for biologic lipid-lowering agents has experienced rapid expansion, driven by rising cardiovascular disease prevalence, advancements in biologic therapeutics, and evolving treatment guidelines emphasizing aggressive LDL cholesterol reduction. Evolocumab emerged as a leading agent within this space since its approval by the FDA in 2015, capturing significant market share in the anti-LDL therapy segment.

Market Size and Growth

The global PCSK9 inhibitor market was valued at approximately USD 3.8 billion in 2021 and is projected to reach USD 9.2 billion by 2028, representing a compound annual growth rate (CAGR) of around 14%[1]. Evolocumab, as one of the first and most extensively prescribed PCSK9 inhibitors, contributes substantially to this growth, with its sales anticipated to sustain upward momentum despite increasing competition.

Key Therapeutic Segments

Evolocumab primarily targets patients with familial hypercholesterolemia (FH), a genetically predisposed form requiring aggressive LDL-lowering strategies, and those with atherosclerotic cardiovascular disease (ASCVD) at high risk. Clinical guidelines now recommend adding PCSK9 inhibitors like evolocumab to maximally tolerated statin therapy for high-risk patients, further broadening its potential user base.

Market Drivers

1. Clinical Evidence Supporting Efficacy and Safety

Pivotal trials such as FOURIER (Further Cardiovascular Outcomes Investigations with PCSK9 Inhibition in Subjects with Elevated Risk) demonstrated that evolocumab significantly reduces LDL cholesterol (by approximately 59%) and associated cardiovascular events (hazard reduction of 15% in major adverse cardiovascular events)[2]. Such robust evidence bolsters physician confidence and facilitates guideline endorsement, expanding the therapeutics' adoption.

2. Regulatory Approvals and Expansions

Beyond initial FDA approval, regulatory agencies worldwide have approved evolocumab for various indications, including homozygous familial hypercholesterolemia (HoFH). Broad label expansion enhances market access, enabling the drug to reach diverse patient populations and increase revenues.

3. Evolving Treatment Guidelines

Major guidelines from the American Heart Association (AHA) and European Society of Cardiology (ESC) now recommend PCSK9 inhibitors as add-on therapy for high-risk patients when LDL targets are unmet, thereby catalyzing demand.

4. Patient Population Growth

The rising burden of cardiovascular risk factors, driven by demographic shifts, obesity, and diabetes prevalence, amplifies the demand for potent lipid-lowering agents, including evolocumab.

5. Competitive Landscape and Biosimilar Threats

While evolocumab’s patent life continues, upcoming biosimilars or emerging therapies threaten to erode market share. However, currently, biosimilar competition for PCSK9 inhibitors remains limited due to complex manufacturing and regulatory hurdles.

Market Challenges

1. Cost and Reimbursement Barriers

Evolocumab's high annual list price (~USD 14,000) initially limited uptake. Despite reductions in negotiated prices and expanded insurance coverage, cost remains a barrier, especially in developing regions.

2. Adherence and Administration Preferences

Evolocumab requires biweekly or monthly subcutaneous injections, which may impact patient adherence. The advent of oral therapies could influence its long-term market penetration.

3. Competitive Agents and Pipeline Drugs

Alirocumab, another PCSK9 inhibitor from Regeneron and Sanofi, offers similar efficacy with competitive pricing, intensifying competition. Additionally, emerging therapies like inclisiran (a small interfering RNA) promise sustained LDL reduction with once-every-six-month dosing.

4. Patent Expiry and Biosimilar Entry

Patent expiration could usher in biosimilar entrants, potentially reducing pricing and margins. Strategic patent protections and lifecycle management are critical to sustaining profitability.

Financial Trajectory and Revenue Outlook

Historical Sales Performance

Since its launch, evolocumab has generated substantial revenues for Amgen. In 2021, revenues from PCSK9 inhibitors, primarily evolocumab, reached approximately USD 2.4 billion globally, reflecting strong adoption. Growth accelerated through 2018–2020, driven by expansion into new markets and indication approvals.

Future Revenue Drivers

• Market Expansion: Increased prescribing in Europe, Asia-Pacific, and emerging markets as awareness and reimbursement coverage improve.
• Indication Expansion: Ongoing studies explore evolocumab's utility in other lipid disorders and cardiovascular conditions, potentially broadening its use.
• Pricing Strategies: Negotiated rebates, value-based pricing agreements, and clinical evidence supporting cost-effectiveness will influence revenue stability.

Potential Revenue Risks

• Pricing Pressures: Payer pushback and biosimilar competition may constrain pricing power.
• Market Saturation: As the current eligible patient pool approaches saturation, incremental sales may plateau.
• Pipeline Disruptions: Competitive pipeline drugs could divert focus or reduce growth prospects.

Strategic Initiatives for Sustained Growth

Amgen’s strategic focus involves differentiating evolocumab through real-world evidence generation, enhancing patient adherence via device innovations, and expanding indications via clinical trials. Direct-to-consumer marketing and clinician education campaigns are also critical to maintaining market momentum.

Conclusion

Evolocumab’s market dynamics are shaped by a confluence of clinical efficacy, regulatory support, healthcare policy shifts, and competitive pressures. While current financial trajectories reflect robust growth, future performance hinges on strategic positioning amid evolving therapeutic landscapes, pricing pressures, and innovative pipeline entrants.

Key Takeaways

• Evolocumab benefits from strong clinical evidence and broad regulatory approvals, underpinning its market success.
• Its revenues are projected to grow steadily, driven by expanding indications and geographic reach, albeit with potential constraints from biosimilar competition and cost pressures.
• Cost and administration are ongoing barriers, influencing patient adherence and payer acceptance.
• Strategic lifecycle management and pipeline development remain essential for sustained financial performance.
• The evolving competitive landscape necessitates agile marketing, pricing strategies, and evidence generation to secure long-term leadership.

FAQs

1. What is evolocumab, and how does it work?
   Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), increasing LDL receptor availability on liver cells and enhancing clearance of LDL cholesterol from the bloodstream.

2. What are the main clinical benefits of evolocumab?
   Evolocumab significantly reduces LDL cholesterol levels—up to 59%—and has demonstrated reductions in major cardiovascular events, especially in high-risk populations with familial hypercholesterolemia or established ASCVD.

3. How does the cost of evolocumab impact its market penetration?
   Initially priced around USD 14,000 annually, high costs limited adoption. Price reductions, reimbursement negotiations, and value-based contracts have improved access, but cost remains a barrier in certain markets.

4. What competitive challenges does evolocumab face?
   Major challenges include competition from similar PCSK9 inhibitors like alirocumab, upcoming therapies such as inclisiran, potential biosimilar entry upon patent expiry, and alternative oral lipid-lowering agents.

5. What is the outlook for evolocumab’s revenue in the next five years?
   With continued regulatory approvals, indication expansion, and increasing cardiovascular risk prevalence, evolocumab’s revenues are expected to maintain growth, subject to competitive and pricing dynamics.

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References

[1] Grand View Research. “PCSK9 Inhibitors Market Size, Share & Trends Analysis Report By Drug Type, By Application, By Region, And Segment Forecasts, 2022-2028.”

[2] Sabatine, M. S., et al. (2017). "Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease." The New England Journal of Medicine, 376, 1713-1722.