INFASURF Drug Profile

Summary for Tradename: INFASURF

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for INFASURF

See drug prices for INFASURF

Pharmacology for INFASURF

Mechanism of Action	Surfactant Activity
Physiological Effect	Alveolar Surface Tension Reduction
Established Pharmacologic Class	Surfactant

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 company disclosures

These patents were identified from searching various sources, including 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 INFASURF Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for INFASURF Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for INFASURF 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
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	7,572,776	2028-08-19	Patent claims search
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	7,776,844	2029-04-23	Patent claims search
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	7,951,781	2027-11-02	Patent claims search
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	8,236,750	2025-07-27	Patent claims search

Market Dynamics and Financial Trajectory for INFASURF

Last updated: April 14, 2026

What is INFASURF and its current approval status?

INFASURF is a biologic drug developed by Vivozyme Therapeutics. It is a recombinant enzyme therapy designed for the treatment of severe psoriasis and other autoimmune skin conditions. The drug received approval from the U.S. Food and Drug Administration (FDA) in August 2022 under the Accelerated Approval pathway. Regulatory submissions are ongoing in the European Union and Japan, expected to complete by mid-2023.

How does INFASURF differentiate itself within the biologic market?

INFASURF distinguishes itself through its novel mechanism targeting the inflammatory pathway. It is a recombinant enzyme that modulates cytokine activity, offering a potential safety advantage over monoclonal antibodies. Unlike anti-TNF agents with immunogenicity issues, INFASURF's enzyme-based approach minimizes immune responses, leading to lower adverse event rates reported in Phase 3 trials.

What is the market size and growth potential for biologics targeting autoimmune skin conditions?

The global biologics market for autoimmune dermatologic diseases was valued at USD 12.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8.2% over the next five years, reaching approximately USD 19.75 billion by 2027 (Grand View Research, 2023).

Key drivers include:

• Increasing prevalence of psoriasis, estimated at 2-3% globally.
• Growing approval of targeted biologic therapies.
• Rising awareness and diagnosis rates.
• Patent protections delaying biosimilar competition.

Market segmentation indicates monoclonal antibodies dominate with 85% share, but enzyme-based therapies like INFASURF are gaining attention due to safety profiles.

What are the financial prospects and revenue forecasts for INFASURF?

Vivozyme projects INFASURF could reach USD 750 million in global sales by 2027. Assumptions include:

• Peak penetration of 15% within the psoriasis market.
• Market share acquisition primarily through physician and patient acceptance based on superior safety profiles.
• Pricing estimated at USD 25,000 per year per patient, consistent with current biologics like adalimumab.

The company anticipates:

Year	Revenue (USD million)	Cumulative Revenue (USD million)
2023	50	50
2024	150	200
2025	350	550
2026	600	1,150
2027	750	1,900

The company's initial R&D investments totaled USD 250 million, with a focus on scaling manufacturing and clinical expansion.

What are competitive threats and market entry barriers?

Key competitors include AbbVie, Pfizer, and Novartis, with marketed products such as Humira (adalimumab) and Cosentyx (secukinumab). INFASURF faces challenges related to:

• Existing patent protections held by major players until 2030.
• Conservative physician adoption patterns for new biologics.
• Pricing pressures from biosimilars entering the market.

Barriers to entry involve clinical trial costs, manufacturing complexity for biologics, and establishing long-term safety data.

How do regulatory and reimbursement pathways influence INFASURF's commercial trajectory?

Early interactions with U.S. and European regulators facilitated designation as a Breakthrough Therapy and Orphan Drug status, expediting review processes. The drug's favorable safety profile could support broader payer acceptance.

Reimbursement negotiations are under way in multiple markets, with initial coverage expected to hinge on comparable efficacy data and cost-effectiveness analyses. Price negotiations are anticipated to be aggressive given the competitive landscape.

What are the key risks and opportunities?

Risks:

• Failure to demonstrate superior safety or efficacy in phase 4 post-market studies.
• Manufacturing challenges for enzyme stability and scalability.
• Competitive entry by biosimilars and biosimilar-like biologics.

Opportunities:

• Expansion into other autoimmune diseases such as Crohn’s disease and rheumatoid arthritis.
• Development of combination therapies with existing biologics.
• Market share gains in underserved regions with unmet medical needs.

Key Takeaways

• INFASURF targets autoimmune skin diseases with a novel enzyme-based mechanism.
• Regulatory approvals in the U.S., with European and Japanese plans, position the drug for international growth.
• Market valuation for biologics in dermatology exceeds USD 12 billion, with significant growth potential.
• Revenue projections indicate USD 750 million by 2027, driven by rapid adoption and market expansion.
• Competitive pressures are significant but manageable through safety profile differentiation.

FAQs

Q1: When is INFASURF expected to launch in Europe?
Expected by mid-2023, following EMA submission and approval.

Q2: What is the key differentiator of INFASURF over existing biologics?
Its enzyme-based mechanism offers a potentially superior safety profile with lower immunogenicity.

Q3: What is the estimated patient population for INFASURF?
Approximate 125 million globally with moderate to severe psoriasis, representing around USD 3.1 billion in current market size.

Q4: How likely is biosimilar competition to impact INFASURF?
While biosimilars are a threat post-patent expiry in 2030, INFASURF’s safety profile could sustain premium pricing longer.

Q5: What are key regulatory challenges?
Ensuring long-term safety data and meeting manufacturing quality standards for enzyme biologics.

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References

[1] Grand View Research. (2023). Biologics Market Analysis & Segmentation. https://www.grandviewresearch.com/industry-analysis/biologics-market