Dinutuximab - Biologic Drug Details

Summary for dinutuximab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for dinutuximab

Recent Clinical Trials for dinutuximab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Federal Research Institute of Pediatric Hematology, Oncology and Immunology	Phase 3
Prof. Franca Fagioli	Phase 2
Children's Hospital Los Angeles	Phase 4

See all dinutuximab clinical trials

Pharmacology for dinutuximab

Mechanism of Action	Glycolipid Disialoganglioside-directed Antibody Interactions
Established Pharmacologic Class	Glycolipid Disialoganglioside-directed Antibody

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 dinutuximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for dinutuximab Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Dinutuximab

Introduction

Dinutuximab, a biologic drug approved for the treatment of high-risk neuroblastoma in children, has been a subject of significant interest due to its clinical efficacy and the challenges associated with its cost and market dynamics. Here, we delve into the market dynamics and financial trajectory of dinutuximab, exploring its approval, clinical benefits, cost-effectiveness, and the broader market context.

Approval and Clinical Benefits

Dinutuximab was the first FDA-approved treatment specifically for patients with high-risk neuroblastoma, marking a significant milestone in pediatric cancer therapy. The approval was based on the demonstrated improvement in event-free survival and overall survival in patients treated with dinutuximab combination therapy compared to those receiving retinoic acid alone[4].

Regulatory Incentives

The development of dinutuximab was facilitated by several regulatory incentives. The FDA granted Orphan Drug status to dinutuximab for the treatment of neuroblastoma in 2010, and in 2013, neuroblastoma was designated a “rare pediatric disease.” Upon approval, United Therapeutics received a Rare Pediatric Disease Priority Review Voucher, which can be used to expedite the review of a future drug application[4].

Cost-Effectiveness Analysis

A critical aspect of dinutuximab's market dynamics is its cost-effectiveness. Recent studies have shown that dinutuximab is not a cost-effective treatment option for children with high-risk neuroblastoma unless its price is significantly reduced. The incremental cost-effectiveness ratio was found to be $236,462.75 per quality-adjusted life-year (QALY), which is far beyond the commonly accepted threshold of $37,920/QALY[1].

Financial Performance

The financial performance of dinutuximab is closely tied to the performance of United Therapeutics Corporation. Despite its clinical benefits, the high cost of dinutuximab poses a significant financial burden on healthcare systems and patients. The drug's price is a major factor influencing its cost-effectiveness, and any reduction in price could significantly impact its financial trajectory[2].

Market Context: Biosimilars

The biologics market, including drugs like dinutuximab, is undergoing a significant transformation with the rise of biosimilars. Biosimilars, which are biologic products that are highly similar to an already approved biologic drug, are expected to increase competition and reduce costs. However, the adoption of biosimilars varies by region, with Europe leading in both the number of biosimilars available and the savings generated from their use. The US market, while growing, still faces challenges such as the presence of pharmacy benefit managers (PBMs) and legal barriers that delay the entry of biosimilars[3].

Impact of Biosimilars on Market Dynamics

The influx of biosimilars is expected to reshape the biologics market significantly. By 2027, the cumulative sales of biosimilars are projected to exceed $129 billion, with savings estimated to be over $180 billion. This trend could pressure the prices of original biologic drugs, including dinutuximab, as manufacturers and payers seek more cost-effective alternatives[3].

Patient Access and Affordability

The high cost of dinutuximab raises concerns about patient access and affordability. The drug's inpatient treatment regimen, which involves infusions over several days, adds to the overall cost. Ensuring that patients have access to this life-saving treatment while managing its financial implications is a critical challenge for healthcare systems and policymakers[5].

Future Outlook

The future of dinutuximab will likely be influenced by several factors, including potential price adjustments, the emergence of biosimilars, and changes in healthcare policies. Public-private partnerships, such as the one between United Therapeutics and the National Cancer Institute, will continue to play a crucial role in the development and commercialization of pediatric cancer therapies[4].

Lessons Learned

The approval and market dynamics of dinutuximab provide valuable lessons for the development of future pediatric cancer therapies. It highlights the importance of regulatory incentives, public-private partnerships, and the need for cost-effective treatments. The FDA's approach to expediting the review process for drugs addressing unmet medical needs, especially in pediatric cancers, is a model that could be replicated for other rare and life-threatening conditions[4].

Key Takeaways

• Clinical Efficacy: Dinutuximab has demonstrated significant clinical benefits in treating high-risk neuroblastoma.
• Cost-Effectiveness: The drug is not cost-effective at its current price, necessitating a significant price reduction.
• Market Context: The rise of biosimilars is expected to impact the biologics market, potentially reducing costs and increasing competition.
• Regulatory Incentives: FDA incentives such as Orphan Drug status and Priority Review Vouchers have supported the development of dinutuximab.
• Patient Access: Ensuring affordability and access to dinutuximab remains a critical challenge.

FAQs

Q: What is dinutuximab used for?

Dinutuximab is used for the treatment of high-risk neuroblastoma in children. It was the first FDA-approved treatment specifically for this condition[4].

Q: Is dinutuximab cost-effective?

No, dinutuximab is not considered cost-effective at its current price. It would need a significant price reduction to meet commonly accepted cost-effectiveness thresholds[1].

Q: How does the rise of biosimilars affect dinutuximab?

The rise of biosimilars could increase competition and pressure the prices of original biologic drugs like dinutuximab, potentially making it more affordable[3].

Q: What regulatory incentives supported the development of dinutuximab?

Dinutuximab received Orphan Drug status and a Rare Pediatric Disease Priority Review Voucher, which facilitated its development and expedited its FDA review[4].

Q: What are the main challenges in patient access to dinutuximab?

The high cost of dinutuximab and its inpatient treatment regimen are significant barriers to patient access and affordability[5].

Sources

1. Cost-effectiveness analysis of dinutuximab β for the treatment of children with high-risk neuroblastoma. PubMed.
2. UNITUXIN (Dinutuximab) - Patent and Exclusivity Information. DrugPatentWatch.
3. A Biosimilar Wave Looms Large Over US Biologics Market. Drug Topics.
4. Approval of Dinutuximab for High-Risk Neuroblastoma. ASCO Post.
5. The currently available anti-GD2 chimeric antibody dinutuximab requires inpatient treatment. Annals of Oncology.

Last updated: 2024-12-18