Talimogene laherparepvec - Biologic Drug Details

Summary for talimogene laherparepvec

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

Recent Clinical Trials for talimogene laherparepvec

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Binhui Biopharmaceutical Co., Ltd.	PHASE1
Amgen	PHASE2
John Rieth	PHASE2

See all talimogene laherparepvec clinical trials

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 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 talimogene laherparepvec Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,034,938	2033-08-30	DrugPatentWatch analysis and company disclosures
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,100,034	2037-07-25	DrugPatentWatch analysis and company disclosures
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,544,125	2038-09-07	DrugPatentWatch analysis and company disclosures
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,626,463	2033-08-02	DrugPatentWatch analysis and company disclosures
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	11,142,580	2038-06-01	DrugPatentWatch analysis and company disclosures
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	11,266,743	2038-10-25	DrugPatentWatch analysis and company disclosures
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	7,223,593	2021-01-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for talimogene laherparepvec 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
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,034,938	2033-08-30	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,100,034	2037-07-25	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,544,125	2038-09-07	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10,626,463	2033-08-02	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	11,142,580	2038-06-01	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	11,266,743	2038-10-25	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	11,441,188	2037-11-13	Patent claims search

International Patents for talimogene laherparepvec

Country	Patent Number	Estimated Expiration
China	1250732
Chile	2019003393
Denmark	1252322
Spain	2988336
South Korea	102613409
European Patent Office	1568779
Belgium	2016C033

Supplementary Protection Certificates for talimogene laherparepvec

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
30/2016	Austria		PRODUCT NAME: TALIMOGENE LAHERPAREPVEC; REGISTRATION NO/DATE: EU/1/15/1064 (MITTEILUNG) 20151218
1690028-4	Sweden		PRODUCT NAME: TALIMOGENE LAHERPAREPVEC; REG. NO/DATE: EU/1/15/1064 20151218
C201630038	Spain		PRODUCT NAME: TALIMOGEN LAHERPAREPVEC; NATIONAL AUTHORISATION NUMBER: EU/1/15/1064; DATE OF AUTHORISATION: 20151216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1064; DATE OF FIRST AUTHORISATION IN EEA: 20151216
29/2016	Austria		PRODUCT NAME: TALIMOGENE LAHERPAREPVEC; REGISTRATION NO/DATE: EU/1/15/1064 (MITTEILUNG) 20151218
300821	Netherlands		PRODUCT NAME: TALIMOGENE LAHERPAREPVEC; REGISTRATION NO/DATE: EU/1/15/1064 20151218
2016C/034	Belgium		PRODUCT NAME: TALIMOGENE LAHERPAREPVEC; AUTHORISATION NUMBER AND DATE: EU/1/15/1064 20151218
2016/027	Ireland		PRODUCT NAME: TALIMOGENE LAHERPAREPVEC; REGISTRATION NO/DATE: EU/1/15/1064/001 EU/1/15/1064/002 20151216

Market Dynamics and Financial Trajectory for the Biologic Drug: Talimogene Laherparepvec

Last updated: July 29, 2025

Introduction

Talimogene laherparepvec (T-Vec), marketed under the brand name Imlygic, represents a pioneering oncolytic immunotherapy designed for the treatment of melanoma. Developed by BioVex (later acquired by Amgen), T-Vec signifies a significant growth node within the broader landscape of biologic cancer therapies. This article explores the evolving market dynamics and financial trajectory of T-Vec, analyzing factors influencing its commercial adoption, competitive positioning, and future forecast.

Market Overview and Therapeutic Landscape

T-Vec was approved by the U.S. Food and Drug Administration (FDA) in 2015 for melanoma patients with unresectable cutaneous, subcutaneous, and nodal lesions. It is the first oncolytic virus therapy approved in the United States, a milestone that positioned it as a novel immunotherapy agent with unique mechanisms of action—selectively infecting and lysing tumor cells, subsequently eliciting systemic anti-tumor immune responses.

The global melanoma market, driven by rising incidence rates and advances in immunotherapy, has seen an accelerated shift toward biologic agents. T-Vec initially faced limited competition but soon encountered competition from immune checkpoint inhibitors, notably pembrolizumab and nivolumab, which demonstrated superior efficacy in advanced melanoma, impacting T-Vec’s market share. The broader biologic market is witnessing growth fueled by the rising prevalence of skin cancers, expanding indications for immunotherapies, and technological advances facilitating personalized treatment options.

Market Dynamics Influencing T-Vec

1. Competitive Landscape

The efficacy profile of T-Vec has been challenged by immune checkpoint inhibitors that prepared the standard of care for melanoma. Clinical trials such as the MASTERKEY-265 study revealed that combining T-Vec with pembrolizumab enhanced response rates, prompting pharmaceutical strategies to reassess positionality for T-Vec. Nonetheless, monotherapy with T-Vec remains valuable for specific patient subsets, especially those unfit for systemic immunotherapy or with localized disease.

2. Regulatory Status and Approvals

Beyond the FDA approval, T-Vec has received additional regulatory designations. The European Medicines Agency (EMA) granted conditional approval in 2016, though with limited indications. Ongoing trials aim to expand its label to include other skin cancers such as Merkel cell carcinoma and cutaneous metastases. Regulatory decisions with broader approvals could significantly influence the market trajectory.

3. Reimbursement and Pricing Trends

Pricing strategies for T-Vec have been conservative, reflecting its novel but niche role amidst inadequately reimbursed early adoption phases. Reimbursement frameworks vary by geography, with favorable policies in the US driven by clear clinical benefits in specific cases. However, reimbursement challenges persist as payers weigh clinical outcomes against higher biologic pricing.

4. Technological and Scientific Advances

Advances in engineering or combination therapies influence T-Vec's market dynamics. Novel oncolytic viruses and immunocombinational regimens aim to surpass T-Vec’s efficacy, prompting ongoing research and development. Improved biomarker identification assists in selecting appropriate patients, optimizing therapeutic outcomes and market access.

5. Clinical Trial Outcomes and Efficacy Profile

Clinical data remain central to T-Vec’s future. The phase III OPTiM trial demonstrated durable tumor responses; however, comparative effectiveness studies show limited superiority over other immunotherapies. Demonstrating clear benefit in expanded indications will be crucial for market growth.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Initial sales of T-Vec in the US hovered around $10 million in 2016, escalating to approximately $50 million by 2019 as awareness increased and usage grew in specialized centers [1]. However, the revenue plateaued with the advent of checkpoint inhibitors dominating first-line therapy.

Projected Growth and Factors Impacting Revenue

Forecasts suggest modest growth for T-Vec, potentially reaching $100–150 million globally by 2025, primarily driven by:

• Expanded Indications: Trials investigating T-Vec for Merkel cell carcinoma and other solid tumors could unlock new revenue streams.
• Combination Therapies: Synergistic adoption with immune checkpoint inhibitors may enhance response rates, leading to increased use.
• Geographical Expansion: Entering emerging markets with growing melanoma incidence could compensate for stagnant US sales.

Challenges in Revenue Growth

Limited comparative advantage over established immune checkpoint therapies constrains significant revenue expansion. Moreover, the high manufacturing costs characteristic of biologics and the competitive pressure from newer therapies further dampen profit margins.

Strategic Investment and R&D Outlook

Amgen and collaborators are investing in next-generation oncolytic viruses and combination regimens, aiming to improve efficacy and broaden applicability. These R&D efforts could, over time, bolster the overall market potential of T-Vec and related therapies, influencing revenue trajectories favorably.

Future Market and Financial Implications

The future of T-Vec hinges on its positioning within combination immunotherapy regimes and the success of ongoing clinical trials. A potential indication expansion into other skin cancers or solid tumors could diversify its market base. Furthermore, cost-effectiveness assessments and benefit evidence in real-world scenarios will influence reimbursement and penetration levels.

Potential Growth Drivers:

• Clinical success in combination therapy trials.
• Regulatory approvals for broader indications.
• Strategic partnerships and licensing agreements.
• Increasing global burden of melanoma and skin cancers.

Potential Barriers:

• Competition from other biologics and small-molecule therapies.
• Less favorable efficacy in monotherapy compared to checkpoint inhibitors.
• Manufacturing complexities elevated by biologic modalities.
• Payer resistance to high-cost personalized therapies.

Conclusion

Talimogene laherparepvec’s market dynamics are characterized by its innovative mechanism, regulatory milestones, and a competitive landscape dominated by newer immunotherapies. While initial market reception was cautious, ongoing clinical developments, combination strategies, and expanding indications could gradually improve its market position. Financially, T-Vec’s trajectory is cautiously optimistic but remains challenged by intense competition and reimbursement hurdles. Its long-term success will depend on strategic positioning, continuous innovation, and clinical validation within a rapidly evolving melanoma treatment landscape.

Key Takeaways

• Market Position: T-Vec pioneered oncolytic immunotherapy, but its market share faces pressure from checkpoint inhibitors.
• Growth Potential: Expansion into additional indications and combination therapies may unlock new revenue streams.
• Challenges: Competitive efficacy, manufacturing costs, and reimbursement policies remain significant hurdles.
• Clinical Development: Ongoing trials targeting other cancers could diversify applications and influence financial performance.
• Strategic Outlook: Combination strategies and geographical expansion are pivotal for future growth.

FAQs

1. What is the primary mechanism of action of talimogene laherparepvec?
   T-Vec is an oncolytic virus engineered to selectively infect and lyse tumor cells, stimulating systemic immune responses against cancer.

2. How does T-Vec compare to immune checkpoint inhibitors in treating melanoma?
   While T-Vec offers durable responses in localized disease, checkpoint inhibitors such as pembrolizumab have shown higher efficacy in advanced stages, leading to their preferential use in standard care.

3. What are the prospects for T-Vec’s approval in other cancers?
   Clinical trials are underway exploring T-Vec in Merkel cell carcinoma and other solid tumors. Positive results could lead to expanded approvals.

4. What factors could enhance T-Vec’s market share in the future?
   Successful combination therapies, broader indications, and regulatory support are key to increasing market penetration.

5. What are the primary challenges hindering T-Vec’s commercial growth?
   Competition from more effective therapies, high manufacturing costs, limited efficacy as a monotherapy, and payer reimbursement restrictions pose significant barriers.

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Sources
[1] Amgen, "Imlygic (talimogene laherparepvec) US Prescribing Information," 2022.