Trastuzumab-pkrb - Biologic Drug Details

Summary for trastuzumab-pkrb

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for trastuzumab-pkrb

Mechanism of Action	HER2/Neu/cerbB2 Antagonists
Established Pharmacologic Class	HER2/neu Receptor Antagonist

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 trastuzumab-pkrb Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for trastuzumab-pkrb Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for trastuzumab-pkrb Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of Trastuzumab (Herceptin and Biosimilars)

Introduction

Trastuzumab, marketed under the brand name Herceptin, is a monoclonal antibody used to treat HER2-positive breast cancer and other conditions. With the expiration of key patents, the market has seen the entry of several biosimilars, significantly altering the market dynamics and financial trajectory of this drug.

Historical Context and Exclusivity

Trastuzumab was first approved by the FDA in 1998 and has since become a cornerstone in the treatment of HER2-positive breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. For nearly two decades, Herceptin enjoyed exclusivity, contributing significantly to Roche's oncology revenue[4].

Patent Expiration and Biosimilar Entry

The exclusivity period for Herceptin ended with key patent expirations in 2019, paving the way for biosimilar entries. As of 2024, several trastuzumab biosimilars have been approved by the FDA, including:

• Ogivri (trastuzumab-dkst) by Mylan and Biocon, approved in December 2017.
• Herzuma (trastuzumab-pkrb) by Celltrion, approved in December 2018.
• Kanjinti (trastuzumab-anns) by Amgen and Allergan, approved in June 2019.
• Ontruzant (trastuzumab-dttb) by Samsung Bioepis, approved in January 2019.
• Trazimera (trastuzumab-qyyp) by Pfizer, approved in March 2019[4].

Market Share and Adoption

The entry of biosimilars has led to a significant shift in market share. As of Q1 2024, biosimilars account for 86% of the trastuzumab market, with the first-to-market biosimilar, Kanjinti, maintaining a dominant position since Q4 2020[1][3].

Volume Market Share

• Biosimilars like Ogivri, Herzuma, and Ontruzant have gained substantial market share, with Ogivri recently increasing its market share by 5% compared to Q4 2023[1].

Average Sales Price (ASP) Trends

The introduction of biosimilars has drastically reduced the ASP of trastuzumab products. As of Q3 2024:

• The average ASP of all trastuzumab products is $1,589, a 63% reduction from the reference product's ASP at the time of the first biosimilar launch.
• The average ASP for biosimilars alone is $1,288, a 70% reduction[1].

Economic Impact and Cost Savings

The entry of biosimilars has significant economic implications:

Cost Reduction

• The competition from biosimilars has led to substantial cost savings. For instance, a study estimated that at a 15% lower cost than the reference drug, 14 additional patients could be treated; at a 35% discount, an additional 47 patients could be treated[2].

Administrative Costs

• The shift from intravenous (IV) to subcutaneous (SC) administration, allowed by some biosimilars, can further reduce costs. A cost analysis from the PERSEPHONE trial indicated an average savings of $12,800 for 6 months of trastuzumab treatment compared to 12 months, regardless of the administration route[2].

Market Competition

• The presence of multiple biosimilars has increased competition, leading to a more dynamic market. Recent trends show that biosimilars with the lowest ASPs maintain the dominant market share, although newer entrants like Ogivri are gaining ground[1].

Financial Trajectory

The financial trajectory of trastuzumab has been significantly impacted by the entry of biosimilars:

Revenue Impact

• Herceptin's sales revenue, which was $2.87 billion in 2018, has seen a decline with the market share shift towards biosimilars. The average ASP reduction of 63% to 70% indicates a substantial drop in revenue for the reference product[2].

Savings and Access

• Despite the high initial cost of trastuzumab, the introduction of biosimilars has improved access to treatment. In the United States, Medicare Part B and Medicaid plans cover trastuzumab therapy, but out-of-pocket costs remain a concern. Biosimilars have helped mitigate these costs[2].

Future Outlook

The future of the trastuzumab market is likely to be shaped by continued competition among biosimilars and potential new entrants:

Market Share Evolution

• As more biosimilars enter the market, the competition is expected to increase, potentially leading to further price reductions and changes in market share dynamics[1].

Regulatory Environment

• Regulatory approvals and changes in healthcare policies will continue to influence the market. For example, the approval of new biosimilars and changes in reimbursement policies can impact market share and ASP trends[3].

Key Takeaways

• Biosimilar Dominance: Biosimilars now dominate the trastuzumab market, accounting for 86% of the market share.
• Price Erosion: The average ASP of trastuzumab products has decreased significantly, with biosimilars reducing prices by up to 70%.
• Cost Savings: The introduction of biosimilars has led to substantial cost savings, improving access to treatment.
• Market Competition: Multiple biosimilars are competing for market share, with newer entrants gaining ground.
• Future Outlook: Continued competition and regulatory changes will shape the future of the trastuzumab market.

FAQs

What is the current market share of trastuzumab biosimilars?

As of Q1 2024, biosimilars account for 86% of the trastuzumab market[1].

How have biosimilars affected the average sales price (ASP) of trastuzumab?

The average ASP of all trastuzumab products has decreased by 63%, and for biosimilars alone, it has decreased by 70% compared to the reference product's ASP at the time of the first biosimilar launch[1].

What are the economic benefits of using trastuzumab biosimilars?

Biosimilars have led to significant cost savings, allowing more patients to be treated at a lower cost. For example, at a 35% discount, an additional 47 patients could be treated compared to the reference product[2].

How do biosimilars impact the administration costs of trastuzumab?

The shift from IV to SC administration, allowed by some biosimilars, can reduce administrative costs. A study estimated an average savings of $12,800 for 6 months of trastuzumab treatment compared to 12 months[2].

What is the future outlook for the trastuzumab market?

The market is expected to remain competitive with continued price reductions and changes in market share dynamics as more biosimilars enter the market and regulatory environments evolve[1][3].

Sources

1. Samsung Bioepis: Biosimilar Market Dynamics - SAMSUNG BIOEPIS. Q3 2024.
2. AJMC: Integrating Trastuzumab Biosimilars and HER2-Directed Therapies into HER2-Positive Breast Cancer Management. April 2020.
3. Samsung Bioepis: Biosimilar Market Report. Q1 2024.
4. Biosimilar Development: Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End. April 2019.

Last updated: 2024-12-20