Peginterferon alfa-2a - Biologic Drug Details

Summary for peginterferon alfa-2a

Tradenames:	1
High Confidence Patents:	1
Applicants:	2
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for peginterferon alfa-2a
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for peginterferon alfa-2a

Recent Clinical Trials for peginterferon alfa-2a

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai Institute Of Biological Products	Phase 2
Chinese Academy of Medical Sciences Dermatology Hospital	Phase 2
Eiger BioPharmaceuticals	Phase 3

See all peginterferon alfa-2a clinical trials

Pharmacology for peginterferon alfa-2a

Established Pharmacologic Class	Interferon alpha
Chemical Structure	Interferon-alpha

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 peginterferon alfa-2a Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for peginterferon alfa-2a Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	5,618,698	2003-12-13	Company disclosures

3) Low Certainty: US Patents for peginterferon alfa-2a 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
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	10,071,108	2033-09-11	Patent claims search
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	10,392,349	2034-01-16	Patent claims search
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	10,478,444	2029-10-27	Patent claims search
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	10,537,580	2035-03-19	Patent claims search
Pharmaand Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	10,596,173	2038-05-03	Patent claims search

International Patents for peginterferon alfa-2a

Country	Patent Number	Estimated Expiration
Australia	5750490
Finland	852377
Israel	96581
Finland	93470
China	1016795

Market Dynamics and Financial Trajectory of Peginterferon Alfa-2a (PEGASYS)

Introduction

Peginterferon alfa-2a, marketed under the brand name PEGASYS, is a biologic drug used primarily in the treatment of chronic hepatitis B and C, as well as other conditions. This article delves into the market dynamics and financial trajectory of PEGASYS, examining the broader context of the PEGylated drugs market and the specific factors influencing its growth.

Global PEGylated Drugs Market Overview

The global PEGylated drugs market has been experiencing significant growth, driven by several key factors. As of 2019, the market size was valued at USD 7,003.6 million and is projected to reach USD 10,074.85 million by 2032, growing at a CAGR of 2.8%[1].

Key Drivers of the Market

Growing Incidence of Chronic Diseases

The increasing prevalence of chronic diseases such as cancer, hepatitis C, and rheumatoid arthritis is a major driver of the PEGylated drugs market. These conditions require advanced therapeutic options, and PEGylated drugs like PEGASYS offer enhanced efficacy and reduced side effects compared to their non-PEGylated counterparts[1][4].

Advancements in Biopharmaceuticals

Advancements in biotechnology and pharmaceutical research have led to the development of more effective PEGylated drugs. Innovations in drug delivery mechanisms, such as those seen in mRNA vaccines during the COVID-19 pandemic, further boost the market. These advancements have improved the therapeutic outcomes and patient compliance, contributing to the market's growth[1][4].

Financial Trajectory of PEGASYS

Historical Performance

PEGASYS has benefited from the overall growth trends in the PEGylated proteins market. The global PEGylated proteins market size was valued at USD 1.14 billion in 2021 and is expected to grow at a CAGR of 11.71% from 2022 to 2030, reaching USD 3.06 billion by 2030[1].

Revenue Contribution

The hepatitis segment, where PEGASYS is primarily used, was valued at USD 156 million in 2017. Although this segment is anticipated to follow a declining trend due to the emergence of new treatments, the launch of PEGASYS and similar drugs continues to contribute to market growth. The combination therapy of PEGASYS with other antiviral drugs, such as ribavirin, has been a significant revenue contributor[4].

Regional Dynamics

North America and Europe

North America and Europe are significant regions for the PEGylated drugs market, driven by high R&D investments, advanced healthcare infrastructure, and a high prevalence of chronic diseases. These regions are expected to continue driving the market growth, with North America dominating the industry due to its developed infrastructure and economic conditions[1][4].

Emerging Markets

In emerging markets like India and Egypt, the introduction of generic and biosimilar versions of PEGASYS has significantly reduced treatment costs. For instance, in India, Roche started marketing pegylated interferon alpha-2a under the brand name Exxura in 2013, reducing the price by more than 50% within a year. Similarly, in Egypt, the introduction of alternative pegylated interferon alpha products led to a competitive environment, resulting in lower prices and increased accessibility[3].

Competitive Landscape

The market for PEGylated drugs, including PEGASYS, is highly competitive with several major pharmaceutical and biotechnology companies involved. Companies like Roche, which markets PEGASYS, continue to invest heavily in R&D to maintain market share. The patent expiry of novel PEGylated therapeutics has led to increased competition and industry consolidation[1].

Challenges and Opportunities

Side Effects and Drug Failure

Despite the benefits, PEGylated drugs like PEGASYS face challenges such as severe side effects and drug failure. These issues can impede market growth but also drive innovation towards safer and more effective treatments. The use of PEGASYS is associated with a wide range of severe adverse effects, including neuropsychiatric complications, cardiovascular issues, and autoimmune disorders[2].

Continuous Research and Development

The continuous need for better drug-delivery mechanisms and the development of novel therapeutics provide significant opportunities for growth. The COVID-19 pandemic has accelerated research activities, leading to increased spending by governments and key players, which positively impacts the market. This ongoing R&D is crucial for addressing the challenges associated with PEGASYS and other PEGylated drugs[1].

Pricing and Accessibility

The high cost of PEGASYS has been a significant barrier to access, especially in low- and middle-income countries. A full treatment course of PEGASYS can cost between USD 10,000 to USD 20,000 per patient. However, initiatives such as those in Egypt, where the introduction of generic and biosimilar products has reduced prices significantly, have improved accessibility. For example, the Egyptian Ministry of Health negotiated progressive price reductions with Roche and Merck, bringing the 48-week treatment cost down to about USD 2,000 per patient[3].

Access Programs

To address the issue of affordability, various access programs have been established. The Genentech Access to Care Foundation (GATCF) helps patients who are uninsured or have been denied coverage access PEGASYS either for free or at reduced cost. Eligibility criteria include an annual adjusted household income of less than $100,000 and either no insurance or denial of coverage[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of PEGASYS. The World Health Organization (WHO) added pegylated interferon alpha to its Essential Medicines List in 2013, highlighting its importance in treating chronic hepatitis. However, there is a need for more progressive WHO guidance to ensure immediate treatment options for patients in developing countries. Regulatory bodies like the European Medicines Agency (EMA) and the FDA closely monitor the safety and efficacy of PEGASYS, ensuring that it meets stringent standards[3][4].

Clinical Efficacy

PEGASYS has shown significant clinical efficacy in treating chronic hepatitis C when used in combination with other antiviral drugs like ribavirin. The sustained virological response (SVR) rates for PEGASYS and ribavirin combination therapy range from 36% for genotype 1 to 59% for genotypes 2-6 after 48 weeks of treatment. This efficacy has been a key factor in its market success, despite the emergence of newer interferon-free antiviral therapies[2][4].

Future Outlook

The future outlook for PEGASYS is mixed. While the drug continues to benefit from the growing demand for PEGylated drugs, it faces significant competition from newer treatments. The decline in the hepatitis segment due to the emergence of interferon-free therapies is a challenge. However, ongoing R&D and the introduction of generic and biosimilar products are expected to maintain market growth and improve accessibility.

Key Takeaways

• Growing Market: The global PEGylated drugs market is driven by the growing incidence of chronic diseases and advancements in biopharmaceuticals.
• Financial Performance: PEGASYS benefits from the overall growth trends in the PEGylated proteins market, with significant revenue contributions from the hepatitis segment.
• Regional Dynamics: North America and Europe are key regions driving market growth, while emerging markets are becoming increasingly important due to reduced prices and improved accessibility.
• Challenges and Opportunities: Despite challenges like severe side effects, continuous R&D activities and industry consolidation present opportunities for growth.
• Regulatory and Clinical Efficacy: Regulatory bodies ensure the safety and efficacy of PEGASYS, which has shown significant clinical efficacy in treating chronic hepatitis C.

FAQs

What is the projected market size of the global PEGylated drugs market by 2032?

The global PEGylated drugs market is expected to reach USD 10,074.85 million by 2032[1].

What is the CAGR of the PEGylated drugs market from 2019 to 2032?

The PEGylated drugs market is expected to exhibit a CAGR of 2.8% from 2019 to 2032[1].

Which segment dominates the PEGylated proteins market?

The consumables segment, including kits and reagents, dominates the PEGylated proteins market with a share of 63.21% in 2021[1].

What are the primary applications of PEGylated drugs?

The primary applications include cancer, hepatitis C, leukemia, severe combined immunodeficiency disease, rheumatoid arthritis, and Crohn's disease[3].

How has the introduction of generic and biosimilar products affected the pricing of PEGASYS?

The introduction of generic and biosimilar products has significantly reduced the pricing of PEGASYS, making it more accessible in emerging markets. For example, in Egypt, the 48-week treatment cost was reduced to about USD 2,000 per patient[3].

Sources

1. Drug Patent Watch: PEGASYS Market dynamics and financial trajectory[1].
2. DrugBank: Peginterferon alfa-2a: Uses, Interactions, Mechanism of Action[2].
3. MSF Access: Pathway to affordable, quality-assured sources of pegylated interferon alpha[3].
4. European Medicines Agency: Pegasys, INN-peginterferon alfa-2a - European Medicines Agency[4].
5. Hematology.org: Access Programs for Peginterferon alfa-2a[5].

Last updated: 2024-12-19