Blinatumomab - Biologic Drug Details

Summary for blinatumomab

Tradenames:	1
High Confidence Patents:	4
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for blinatumomab

Recent Clinical Trials for blinatumomab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Zhejiang University	Phase 1
Sichuan University	Phase 2
Ho Joon Im	Phase 2

See all blinatumomab clinical trials

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. General 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 blinatumomab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for blinatumomab Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2024-11-26	Company disclosures
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2032-04-30	Company disclosures
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2018-04-21	Company disclosures

3) Low Certainty: US Patents for blinatumomab 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.	BLINCYTO	blinatumomab	For Injection	125557		2033-02-08	Patent claims search
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2035-05-04	Patent claims search
Amgen Inc.	BLINCYTO	blinatumomab	For Injection	125557		2032-02-15	Patent claims search

International Patents for blinatumomab

Country	Patent Number	Estimated Expiration
China	101331151
Luxembourg	93067
Brazil	112012009778

Supplementary Protection Certificates for blinatumomab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C01691833/01	Switzerland		PRODUCT NAME: BLINATUMOMABUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65654 25.02.2016
1690016-9	Sweden		PRODUCT NAME: BLINATUMOMAB; REG. NO/DATE: EU/1/15/1047 20151123
122016000028	Germany		PRODUCT NAME: BLINATUMOMAB; REGISTRATION NO/DATE: EU/1/15/1047 20151123

Market Dynamics and Financial Trajectory for Blinatumomab

Market Overview

Blinatumomab, marketed under the brand name Blincyto, is a biopharmaceutical drug that has revolutionized the treatment of acute lymphoblastic leukemia (ALL), particularly in cases that are relapsed or refractory. This drug belongs to the class of bispecific T-cell engagers (BiTEs), which activate the immune system to target and destroy cancer cells.

Global Market Growth

The global Blinatumomab market is anticipated to grow at a compound annual growth rate (CAGR) of 3 to 5% from 2023 to 2031, reaching a significant valuation by the end of the forecast period[4].

Key Drivers

• Unmet Medical Needs: Blinatumomab addresses a critical need in treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia, a condition with limited therapeutic alternatives[1].
• Clinical Efficacy and Safety: The drug has demonstrated strong clinical efficacy and safety, supported by regulatory approvals and positive real-world results[1].
• Advancements in Healthcare Infrastructure: Growing healthcare infrastructure, particularly in North America and Europe, is a significant driver. High spending and sophisticated healthcare systems in these regions support the market's growth[1].
• Increasing ALL Prevalence: The rising incidence of ALL, especially in regions like China and India, drives demand for Blinatumomab[1].

Regional Market Analysis

North America

North America dominates the Blinatumomab market, accounting for more than 47% of the global revenue. This dominance is attributed to high healthcare spending, a sophisticated healthcare infrastructure, and a large pharmaceutical presence. Attractive reimbursement policies also contribute to the market's growth in this region[1].

Europe

The European market benefits from government programs and increasing cancer awareness. Investments in research and rising ALL instances drive demand. However, regulatory hurdles and price caps pose challenges to market growth[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Rising healthcare costs and a large population in countries like China and India are key drivers. Despite the complexity of laws and disparities in healthcare quality, the region shows significant potential for growth[1].

Cost-Effectiveness and Financial Impact

Cost-Effectiveness Analysis

Studies have shown that Blinatumomab is a cost-effective treatment option compared to standard salvage chemotherapy. At an incremental cost-effectiveness ratio (ICER) threshold of $150,000 per quality-adjusted life year (QALY) gained, the probability of Blinatumomab being cost-effective is estimated to be 74%[2].

Financial Performance

Blinatumomab has contributed significantly to the financial performance of its primary manufacturer, Amgen. In 2023, sales of Blincyto rose by 48% to $861 million, reflecting strong demand and the drug's critical role in Amgen's oncology portfolio[3].

Market Players and Competitive Landscape

The Blinatumomab market is dominated by a few large companies, with Amgen being the primary player. Amgen's strong presence in the global pharmaceutical market, coupled with its extensive research and development investments, positions it favorably for continued growth in the Blinatumomab market[1].

Real-World Clinical Experience

Real-world chart reviews have shown that Blinatumomab's efficacy and safety profile in clinical practice are comparable to those observed in clinical trials. The administration of cytoreductive therapy prior to Blinatumomab has been found to be safe and may improve response rates and reduce the risk of severe cytokine release syndrome (CRS)[5].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: Price caps and regulatory complexities, especially in Europe and the Asia Pacific, can hinder market growth[1].
• Adverse Events: The drug is associated with adverse events such as CRS and neurologic toxicity, which require careful management[5].

Opportunities

• Expanding Patient Base: The increasing prevalence of ALL and the growing awareness of cancer treatments offer opportunities for market expansion[1].
• Research and Development: Continuous investments in research and development can lead to improved treatment outcomes and new indications for Blinatumomab[3].

Financial Projections

The Blinatumomab market is expected to continue its upward trend, driven by positive market dynamics. Here are some key financial projections:

• Revenue Growth: The market is projected to grow at a CAGR of 3 to 5% from 2023 to 2031, reaching a significant valuation by the end of the forecast period[4].
• Sales Performance: Amgen's sales of Blincyto are expected to continue growing, driven by strong demand and the drug's critical role in treating ALL[3].

Key Takeaways

• Market Growth: The Blinatumomab market is expected to grow significantly, driven by unmet medical needs, clinical efficacy, and advancements in healthcare infrastructure.
• Regional Dominance: North America leads the market, followed by Europe and the rapidly growing Asia Pacific region.
• Cost-Effectiveness: Blinatumomab is a cost-effective treatment option compared to standard salvage chemotherapy.
• Financial Performance: The drug has contributed substantially to Amgen's financial performance and is expected to continue doing so.
• Challenges and Opportunities: While regulatory hurdles and adverse events pose challenges, the expanding patient base and ongoing research offer significant opportunities.

FAQs

Q: What is Blinatumomab used for?

Blinatumomab, marketed as Blincyto, is used as a second-line treatment for acute lymphoblastic leukemia (ALL) that lacks the Philadelphia chromosome and has relapsed or become resistant to treatment[1].

Q: Which region dominates the Blinatumomab market?

North America dominates the Blinatumomab market, accounting for more than 47% of the global revenue[1].

Q: Is Blinatumomab cost-effective compared to standard chemotherapy?

Yes, Blinatumomab is considered cost-effective compared to standard salvage chemotherapy, with a probability of being cost-effective estimated at 74% at an ICER threshold of $150,000 per QALY gained[2].

Q: What are the common adverse events associated with Blinatumomab?

Common adverse events include cytokine release syndrome (CRS) and neurologic toxicity (NTX)[5].

Q: Who is the primary manufacturer of Blinatumomab?

The primary manufacturer of Blinatumomab is Amgen[1].

Sources

1. We Market Research: Blinatumomab Market Scope, Dynamics, Segmentation, Statistics ...
2. PubMed: Cost-effectiveness of blinatumomab versus salvage chemotherapy ...
3. Amgen Investors: SHAREHOLDERS 2023
4. Market Research Intellect: Global Blinatumomab Market Size And Forecast
5. ASH Publications: Real World Chart Review of Blinatumomab to Treat Patients with ...