Infliximab-qbtx - Biologic Drug Details

Summary for infliximab-qbtx

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 infliximab-qbtx Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for infliximab-qbtx Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for infliximab-qbtx Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Infliximab-qbtx (Ixifi®)

Introduction to Infliximab-qbtx (Ixifi®)

Infliximab-qbtx, marketed as Ixifi®, is a biosimilar to the biologic drug Remicade® (infliximab), which is used to treat various inflammatory conditions including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Here, we delve into the market dynamics and financial trajectory of this biosimilar.

FDA Approval and Market Entry

Ixifi® was approved by the FDA in December 2017 as the third biosimilar to Remicade®, following Inflectra® (infliximab-dyyb) and Renflexis® (infliximab-abda)[2].

Indications and Usage

Ixifi® is indicated for the same conditions as its reference product, Remicade®, including adult and pediatric Crohn’s disease, ulcerative colitis in adult patients, rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. This broad range of indications positions Ixifi® as a significant player in the biologics market[2].

Market Share and Competition

As of Q4 2023, the infliximab biosimilar market, which includes Ixifi®, has reached a significant market share. Specifically, the infliximab biosimilar market share has stabilized at 48%[4].

Competition Among Biosimilars

The infliximab biosimilar market is competitive, with multiple biosimilars available, including Inflectra® and Renflexis®. Despite this competition, Ixifi® has managed to carve out a substantial market share, contributing to the overall erosion of the reference product's market dominance[4].

Pricing Dynamics

The introduction of biosimilars like Ixifi® has significantly impacted the pricing of biologic drugs. As of Q2 2024, the average sales price (ASP) of all infliximab products has dropped to $222, representing a 72% decrease from the reference product's ASP at the time of the first biosimilar launch[4].

Price Erosion

The entry of biosimilars has led to substantial price erosion in the biologics market. This trend is expected to continue as more biosimilars enter the market, driving down costs for patients and healthcare systems. For example, the ASP of infliximab biosimilars alone has decreased by 50% compared to the reference product's ASP[4].

Financial Impact

Savings to Healthcare Systems

The adoption of biosimilars like Ixifi® has resulted in significant savings for healthcare systems. It is estimated that the use of biosimilars in the U.S. could save up to $24.6 billion between 2021 and 2025, with a substantial portion of these savings coming from downward pressure on reference biologic prices[3].

Market Exclusivity and Competition

Unlike small molecules, biologics have complex market exclusivity dynamics. The entry of biosimilars disrupts the market exclusivity of originator biologics, leading to increased competition and lower prices. By Q4 2023, 17% of the biologics market was accessible to biosimilars, and this figure is expected to rise as more biosimilars are approved and launched[3].

Clinical Efficacy and Safety

Switching Studies

Several studies have evaluated the safety and efficacy of switching from the originator infliximab to its biosimilars, including Ixifi®. For instance, the NOR-SWITCH trial and other observational studies have shown that switching to biosimilars like CT-P13 (another infliximab biosimilar) does not significantly affect clinical efficacy or safety outcomes in patients with inflammatory bowel disease (IBD)[1][5].

Long-Term Data

Long-term data from various studies indicate that patients who switch to biosimilars like Ixifi® experience similar clinical outcomes as those who remain on the originator drug. For example, a Norwegian cohort study followed patients for 18 months after switching to CT-P13 and found no change in disease activity scores or biomarkers[5].

Regulatory Environment

FDA Approval Pathway

Ixifi® was approved under the abbreviated regulatory pathway of the Biologics Price Competition and Innovation Act (BPCIA), which streamlines the approval process for biosimilars. This pathway has facilitated the entry of multiple biosimilars into the market, increasing competition and driving down prices[2].

Market Trends and Projections

Biosimilar Adoption

The adoption of biosimilars is expected to continue growing, driven by their cost-effectiveness and proven clinical efficacy. By year-end 2019, 17% of the biologics market was accessible to biosimilars, and this figure is projected to increase as more biosimilars are approved and launched[3].

Price Trends

The average sales price of biosimilars, including Ixifi®, is expected to continue decreasing as more competitors enter the market. This trend is evident in the significant price drops observed since the first biosimilar launch[4].

Key Takeaways

• Market Share: Ixifi® has secured a significant market share within the infliximab biosimilar market.
• Pricing Dynamics: The introduction of Ixifi® and other biosimilars has led to substantial price erosion, benefiting healthcare systems and patients.
• Clinical Efficacy: Studies have shown that switching to biosimilars like Ixifi® does not compromise clinical efficacy or safety.
• Financial Impact: The use of biosimilars is projected to save billions of dollars in healthcare costs.
• Regulatory Environment: The FDA's BPCIA pathway has facilitated the approval and launch of multiple biosimilars.

FAQs

What is Ixifi® and how is it used?

Ixifi® is a biosimilar to the biologic drug Remicade® (infliximab), used to treat conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.

How has the market share of Ixifi® evolved?

As of Q4 2023, the infliximab biosimilar market, including Ixifi®, has reached a market share of 48%.

What is the impact of Ixifi® on pricing in the biologics market?

The introduction of Ixifi® and other biosimilars has led to a 72% decrease in the average sales price of infliximab products compared to the reference product's ASP at the time of the first biosimilar launch.

Are there any clinical concerns about switching to Ixifi® from Remicade®?

Studies have shown that switching to biosimilars like Ixifi® does not significantly affect clinical efficacy or safety outcomes in patients with inflammatory bowel disease (IBD).

How much are healthcare systems expected to save with the use of biosimilars like Ixifi®?

The use of biosimilars in the U.S. is estimated to save up to $24.6 billion between 2021 and 2025.

What is the regulatory pathway for approving biosimilars like Ixifi®?

Ixifi® was approved under the Biologics Price Competition and Innovation Act (BPCIA) pathway, which streamlines the approval process for biosimilars.

Sources

1. Lichtenstein et al., "Biosimilars in IBD: FDA FINAL v 2.0 for pdf," m-cersi.
2. Goodwin Law, "FDA Approves Ixifi® (infliximab-qbtx), Third Biosimilar of Remicade®," Goodwin Procter BioSimilars Blog.
3. Aitken, "Biologics Market Dynamics: Setting the Stage for Biosimilars," FTC.
4. Samsung Bioepis, "Biosimilar Market Report Q2 2024," SAMSUNG BIOEPIS.
5. Position statement on the use of biosimilars in inflammatory bowel disease, SMW.