HERCEPTIN HYLECTA Drug Profile

Summary for Tradename: HERCEPTIN HYLECTA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for HERCEPTIN HYLECTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HERCEPTIN HYLECTA

Recent Clinical Trials for HERCEPTIN HYLECTA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Gilead Sciences	Phase 2
Adrienne G. Waks	Phase 2
National Cancer Institute (NCI)	Phase 2/Phase 3

See all HERCEPTIN HYLECTA clinical trials

Recent Litigation for HERCEPTIN HYLECTA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.	2023-11-17
Genentech, Inc. v. Biogen MA Inc.	2023-07-13
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all HERCEPTIN HYLECTA litigation

PTAB Litigation

Petitioner	Date
GEMoaB Monoclonals GmbH et al.	2019-12-20
	2018-04-24
Forty Seven, Inc.	2018-01-08

See all HERCEPTIN HYLECTA litigation

Pharmacology for HERCEPTIN HYLECTA

Mechanism of Action	HER2/Neu/cerbB2 Antagonists
Established Pharmacologic Class	Endoglycosidase HER2/neu Receptor Antagonist
Chemical Structure	Glycoside Hydrolases

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 HERCEPTIN HYLECTA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HERCEPTIN HYLECTA Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for HERCEPTIN HYLECTA 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
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	10,004,742	2039-02-26	Patent claims search
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	10,005,783	2028-10-22	Patent claims search
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	10,005,847	2034-05-27	Patent claims search
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	10,011,659	2034-09-08	Patent claims search
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	10,016,338	2033-03-11	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: HERCEPTIN HYLECTA

Introduction

HERCEPTIN HYLECTA, a formulation of trastuzumab and hyaluronidase-oysk, has been a cornerstone in the treatment of HER2-positive breast cancer and other related conditions since its approval. Developed by Genentech, this biologic drug has enjoyed a long period of market exclusivity, but this is changing with the advent of biosimilar competition.

Herceptin's Market Exclusivity and Patent Expirations

Since its original approval in 1998, Herceptin has been a multibillion-dollar pillar supporting Roche’s oncology division. However, key patent expirations expected before the end of 2019 marked the end of its market exclusivity[1][4].

Impact of Biosimilar Competition

The expiration of Herceptin's patents has paved the way for biosimilar competition. The FDA has approved several biosimilars to Herceptin, including Mylan’s Ogivri and Pfizer’s Trazimera. This competition is expected to significantly reduce the financial burden of biologic treatments on the healthcare system, as the prices of biologics have risen substantially without direct competition[1][4].

Competitive Landscape

The anticipated conclusion of Herceptin’s market exclusivity led to a sequential launch of biosimilars. Mylan’s Ogivri and Pfizer’s Trazimera are among the first to enter the market. Despite this, Genentech is expected to maintain a strong market presence due to its 20-year history of providing trastuzumab treatment and a complex system of multiple stakeholders that favor reference product manufacturers[1][4].

Alternative Routes of Administration

Genentech has introduced Herceptin HYLECTA, a subcutaneous formulation of trastuzumab, which offers an alternative to the traditional intravenous administration. This move aims to soften the impact of biosimilar competition, although the differentiation between subcutaneous and intravenous administration may not be as significant in oncology as in other therapeutic areas[1].

Financial Implications

The introduction of biosimilars is likely to humble biologic manufacturers financially. While Genentech will continue to leverage its long-standing strength in the market, the company will face pressure from competitive price reductions. Herceptin is not the only financial pillar under siege for Genentech, but the immediate financial impact may be mitigated by its established market presence and complex stakeholder network[1][4].

Biosimilar Developers' Strategies

Biosimilar developers are focusing on several key messaging points to position themselves in the market:

• Safety and Reliability: Highlighting a strong history of biologic safety and reliability.
• Education: Emphasizing ongoing biosimilar education to all stakeholder communities.
• Cost Reduction: Positioning biosimilars as a necessity to reduce the financial burden on the healthcare system[1].

Financial Assistance and Patient Access

To maintain patient access, Genentech offers various financial assistance programs, including the Genentech Oncology Co-pay Assistance Program, which can reduce the cost of Herceptin treatment to as little as $0 per treatment for eligible patients with commercial insurance[2][5].

Clinical Indications and Safety Information

Herceptin HYLECTA is indicated for the treatment of adults with HER2-positive breast cancer, including early-stage and metastatic conditions. Patients are selected based on FDA-approved companion diagnostics. The treatment comes with important safety information, including risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity[2][5].

Market Share and Revenue

Herceptin has been one of the top-selling biologics, with cumulative sales exceeding $40 billion since its launch. The top 10 biologics, including Herceptin, have dominated the market, with each having cumulative sales of more than $40 billion over their lifetimes[3].

Regulatory Support for Biosimilars

The FDA has taken steps to approve more biosimilar products and improve the competitive landscape. This regulatory support is crucial for increasing biosimilar competition and reducing healthcare costs. The FDA's commitment to a more competitive market is expected to continue, benefiting both patients and the healthcare system[1][4].

Future Outlook

As biosimilar competition intensifies, Genentech will need to adapt to maintain its market share. The company may focus on innovative delivery methods, enhanced patient support programs, and strategic pricing to mitigate the impact of biosimilars. However, the long-term financial trajectory for Herceptin HYLECTA is likely to be influenced by the increasing presence of biosimilars in the market.

Key Takeaways

• Market Exclusivity: Herceptin's market exclusivity has ended, paving the way for biosimilar competition.
• Biosimilar Launches: Mylan’s Ogivri and Pfizer’s Trazimera are among the first biosimilars to enter the market.
• Financial Impact: Biosimilar competition is expected to reduce the financial burden on the healthcare system and pressure biologic manufacturers financially.
• Alternative Administration: Herceptin HYLECTA offers a subcutaneous administration option.
• Regulatory Support: The FDA is committed to supporting a more competitive biosimilar market.
• Patient Access: Financial assistance programs are available to maintain patient access to Herceptin.

FAQs

What is Herceptin HYLECTA used for?

Herceptin HYLECTA is used for the treatment of adults with HER2-positive breast cancer, including early-stage and metastatic conditions, as well as metastatic gastric or gastroesophageal junction adenocarcinoma[2][5].

What are the key safety concerns associated with Herceptin HYLECTA?

Key safety concerns include cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity. Patients are also at risk of low white blood cell counts and severe lung problems[2][5].

How does the introduction of biosimilars affect Herceptin's market position?

The introduction of biosimilars is expected to reduce Herceptin's market share and revenue due to competitive pricing and increased competition. However, Genentech's established market presence and complex stakeholder network may mitigate the immediate impact[1][4].

What financial assistance options are available for Herceptin HYLECTA?

Genentech offers various financial assistance programs, including the Genentech Oncology Co-pay Assistance Program, which can reduce the cost of treatment to as little as $0 per treatment for eligible patients with commercial insurance[2][5].

How does the FDA support the biosimilar market?

The FDA has taken steps to approve more biosimilar products and improve the competitive landscape, supporting a more competitive market and reducing healthcare costs[1][4].

Sources

1. Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End - Robert Browne, Fuld + Company.
2. Financial Assistance Options | Herceptin® (trastuzumab) - Genentech.
3. Biologics Market Dynamics: Setting the Stage for Biosimilars - FTC.
4. Analysis Of The Biosimilar Market As Herceptin Exclusivity Nears Its End - Robert Browne.
5. Financial assistance options | Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) - Genentech.