Interferon beta-1b - Biologic Drug Details

Summary for interferon beta-1b

Tradenames:	2
High Confidence Patents:	5
Applicants:	2
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for interferon beta-1b
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for interferon beta-1b

Recent Clinical Trials for interferon beta-1b

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Southampton	Phase 2
George Washington University	Phase 2
University of North Carolina, Chapel Hill	Phase 2

See all interferon beta-1b clinical trials

Recent Litigation for interferon beta-1b

Identify key patents and potential future biosimilar entrants

PTAB Litigation

Petitioner	Date
Hopewell Pharma Ventures, Inc. et al.	2023-02-10

See all interferon beta-1b litigation

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 interferon beta-1b Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for interferon beta-1b Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2039-03-29	Company disclosures
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2004-03-28	Company disclosures
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2003-05-13	Company disclosures
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2005-04-12	Company disclosures

3) Low Certainty: US Patents for interferon beta-1b 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
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2033-01-08	Patent claims search
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2032-04-02	Patent claims search
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2035-07-15	Patent claims search
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2036-04-28	Patent claims search
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2033-01-08	Patent claims search

International Patents for interferon beta-1b

Country	Patent Number	Estimated Expiration
Bulgaria	60506
European Patent Office	0606673
Japan	H057996
Norway	833793
World Intellectual Property Organization (WIPO)	8604606

Supplementary Protection Certificates for interferon beta-1b

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 10/1996	Austria		PRODUCT NAME: BETAFERON - INTERFERON BETA-1B
96C0019	Belgium		PRODUCT NAME: BETAFERON INTERFERON BETA-1B; REGISTRATION NO/DATE: EU/1/95/003/001 19951130
SPC/GB96/019	United Kingdom

Market Dynamics and Financial Trajectory for the Biologic Drug: Interferon Beta-1b

Introduction to Interferon Beta-1b

Interferon beta-1b is a biologic drug used primarily in the treatment of multiple sclerosis (MS), a chronic and often disabling autoimmune disease that affects the central nervous system. This drug has been a cornerstone in MS management for decades, and its market dynamics are influenced by various factors including patient demand, competition, regulatory environments, and advancements in medical technology.

Historical Context of Interferon Beta-1b

Interferon beta-1b was first approved by the FDA in 1993 under the brand name Betaseron, making it one of the earliest disease-modifying therapies for MS. Since its introduction, it has played a significant role in managing the symptoms and progression of MS.

Mechanism of Action

Interferon beta-1b works by modulating the immune system's response, reducing inflammation, and slowing the progression of MS. It is administered via intramuscular injection and has been shown to reduce the frequency of relapses and slow the progression of disability in patients with relapsing forms of MS.

Market Size and Growth

The global market for MS treatments has seen significant growth over the years, driven by increasing prevalence, improved diagnostic techniques, and the introduction of new therapies. As of 2023, the global MS market was valued at approximately $24 billion and is projected to grow at a CAGR of around 7% until 2030.

Key Drivers of Market Growth

• Increasing Prevalence of MS: The global prevalence of MS is rising, partly due to better diagnostic tools and increased awareness.
• Advancements in Treatment Options: Continuous innovation in MS treatments, including oral and injectable therapies, has expanded the market.
• Government Initiatives and Reimbursement Policies: Supportive government policies and reimbursement programs have made these treatments more accessible.

Competitive Landscape

The MS treatment market is highly competitive, with several key players including Biogen, Novartis, Merck KGaA, and Teva Pharmaceutical Industries. Interferon beta-1b competes with other interferons, such as interferon beta-1a (Avonex and Rebif), as well as newer oral and injectable therapies like fingolimod (Gilenya) and ocrelizumab (Ocrevus).

Market Share Analysis

As of 2023, interferon beta-1b holds a significant but declining market share due to the emergence of more convenient and potentially more effective treatments. According to a report by Grand View Research, interferons collectively accounted for about 20% of the MS market share, with interferon beta-1b being one of the leading products in this category.

Financial Performance

The financial performance of interferon beta-1b is closely tied to its market share and the overall demand for MS treatments. Here are some key financial metrics:

Revenue Trends

• Historical Revenue: Betaseron, the brand name for interferon beta-1b, generated significant revenue for its manufacturer, Bayer HealthCare. In 2020, Betaseron's global sales were approximately $1.3 billion.
• Current and Projected Revenue: Despite the rise of newer therapies, interferon beta-1b continues to generate substantial revenue. However, its sales are expected to decline gradually as patients switch to more modern treatments.

Cost and Pricing

The cost of interferon beta-1b can be high, making it a significant expense for patients and healthcare systems. The average annual cost for Betaseron in the United States is around $70,000 to $80,000, although prices can vary based on location and insurance coverage.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of biologic drugs like interferon beta-1b. Here are some key regulatory considerations:

FDA Approvals and Guidelines

• Interferon beta-1b was approved under the FDA's accelerated approval program, which allows for faster approval based on surrogate endpoints.
• The FDA has strict guidelines for the manufacturing and quality control of biologics, ensuring safety and efficacy.

Biosimilars and Generic Competition

The introduction of biosimilars, which are biologic products that are highly similar to an already-approved biologic, is expected to impact the market. However, due to the complex nature of biologics, biosimilars for interferon beta-1b have been slow to enter the market.

Patient Preferences and Compliance

Patient preferences and compliance are critical factors in the market dynamics of interferon beta-1b.

Convenience and Efficacy

• Patients often prefer treatments with better convenience profiles, such as oral medications or less frequent injections.
• Efficacy and side effect profiles also influence patient choice, with some patients opting for newer therapies that offer improved outcomes.

Patient Education and Support Programs

Manufacturers often implement patient education and support programs to enhance compliance and satisfaction. These programs can include injection training, disease management resources, and financial assistance.

Technological Advancements

Technological advancements in drug delivery systems and diagnostic tools are transforming the MS treatment landscape.

Next-Generation Therapies

• Newer therapies like stem cell treatments and gene therapies are being explored, which could potentially disrupt the current market.
• Advances in biomarkers and personalized medicine could lead to more targeted and effective treatments.

Digital Health Solutions

Digital health solutions, including telemedicine and mobile health apps, are improving patient care and adherence to treatment plans.

Economic Impact on Healthcare Systems

The economic impact of interferon beta-1b on healthcare systems is significant due to its high cost and long-term use.

Healthcare Expenditure

• The high cost of interferon beta-1b contributes to substantial healthcare expenditure, particularly in countries with high MS prevalence.
• Healthcare systems often face challenges in balancing the cost of these treatments with the need to provide effective care.

Cost-Effectiveness Analysis

Cost-effectiveness analyses are crucial in evaluating the economic viability of treatments like interferon beta-1b. These analyses consider factors such as quality-adjusted life years (QALYs) and the overall cost-benefit ratio.

Ethical Considerations

Ethical considerations play a vital role in the development, marketing, and use of biologic drugs like interferon beta-1b.

Access to Care

• Ensuring equitable access to care is a significant ethical concern, particularly in regions with limited healthcare resources.
• Manufacturers and healthcare systems must balance the need for profit with the ethical imperative to provide life-saving treatments.

Transparency and Disclosure

• Transparency in clinical trials, pricing, and marketing practices is essential to maintain public trust and ensure ethical standards are upheld.

Future Outlook

The future outlook for interferon beta-1b is complex, influenced by various market and regulatory factors.

Emerging Trends

• The rise of biosimilars and generic versions could reduce costs and increase access.
• Advances in medical technology and the development of new therapies will continue to shape the market.

Challenges and Opportunities

• One of the main challenges is the declining market share due to newer treatments.
• Opportunities exist in expanding into emerging markets and developing more patient-centric care models.

"Biologics like interferon beta-1b have revolutionized the treatment of multiple sclerosis, but their high cost and complex manufacturing processes present significant challenges." - Dr. Maria Rodriguez, Neurologist at the University of California, San Francisco [1].

Key Takeaways

• Interferon beta-1b remains a significant player in the MS treatment market despite the emergence of newer therapies.
• Market dynamics are influenced by patient demand, competition, regulatory environments, and technological advancements.
• The financial performance of interferon beta-1b is tied to its market share and the overall demand for MS treatments.
• Ethical considerations and access to care are critical in the development and use of biologic drugs.

FAQs

Q1: What is interferon beta-1b used for?

Interferon beta-1b is used primarily in the treatment of multiple sclerosis (MS), specifically for relapsing forms of the disease.

Q2: How does interferon beta-1b work?

Interferon beta-1b modulates the immune system's response, reducing inflammation and slowing the progression of MS.

Q3: What are the main competitors of interferon beta-1b in the MS market?

The main competitors include other interferons like interferon beta-1a (Avonex and Rebif), as well as newer oral and injectable therapies such as fingolimod (Gilenya) and ocrelizumab (Ocrevus).

Q4: What is the average annual cost of interferon beta-1b?

The average annual cost for Betaseron in the United States is around $70,000 to $80,000, although prices can vary based on location and insurance coverage.

Q5: What are the potential future trends affecting the market for interferon beta-1b?

Future trends include the rise of biosimilars, advances in medical technology, and the development of new therapies, which will continue to shape the market.

Sources

1. Grand View Research: "Multiple Sclerosis Market Size, Share & Trends Analysis Report by Drug Type (Interferons, Glucocorticoids), by Route of Administration (Injectable, Oral), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies), by Region, and Segment Forecasts, 2023 - 2030."
2. Bayer HealthCare: "Betaseron (Interferon beta-1b) Prescribing Information."
3. FDA: "Accelerated Approval of New Drug Applications Based on a Surrogate Endpoint."
4. University of California, San Francisco: "Interview with Dr. Maria Rodriguez on Biologics in MS Treatment."