Albiglutide - Biologic Drug Details

Summary for albiglutide

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for albiglutide

Recent Clinical Trials for albiglutide

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Medanta, The Medicity, India	N/A
Wake Forrest Baptist Health	Phase 4
Wake Forest Baptist Health	Phase 4

See all albiglutide 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 albiglutide Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for albiglutide 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
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431			DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2025-01-31	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2028-02-05	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2027-02-22	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2030-04-27	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2026-05-31	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2033-05-10	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for albiglutide 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
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2037-02-09	Patent claims search
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2036-10-31	Patent claims search
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2037-08-11	Patent claims search
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2036-08-30	Patent claims search
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2037-08-03	Patent claims search
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2038-06-13	Patent claims search
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431		2035-05-06	Patent claims search

International Patents for albiglutide

Country	Patent Number	Estimated Expiration
Croatia	P20140243
Australia	2005262576
Mexico	2009008563
South Korea	102233349
New Zealand	597304
European Patent Office	2120977
South Korea	100973615

Supplementary Protection Certificates for albiglutide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132014902293932	Italy		PRODUCT NAME: ALBIGLUTIDE(EPERZAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/908, 20140321
300691	Netherlands		PRODUCT NAME: ALBIGLUTIDE; REGISTRATION NO/DATE: EU/1/13/908 20140326
1490056-7	Sweden		PRODUCT NAME: ALBIGLUTIDE; REG. NO/DATE: EU/1/13/908/001002 20140321

Market Dynamics and Financial Trajectory for the Biologic Drug: Albiglutide

Last updated: July 30, 2025

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Introduction

Albiglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, was developed by GlaxoSmithKline (GSK) for managing type 2 diabetes mellitus (T2DM). Market dynamics and financial trajectories of biologic drugs such as albiglutide are shaped by evolving healthcare policies, competition, technological advancements, and patient demand. Despite its initial promise, albiglutide's commercial journey offers insights into the challenges and shifts in the biologics landscape.

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Overview of Albiglutide

Albiglutide functions as a once-weekly injectable therapy, leveraging a fusion of GLP-1 with human albumin to extend its half-life (per [1]). It entered the market with the aim of improving glycemic control in T2DM patients inadequately managed by oral medications. Its pharmacokinetics promised enhanced convenience, a crucial factor for adherence.

However, the product faced hurdles—including market competition from other GLP-1 receptor agonists like liraglutide and semaglutide, which gained rapid market share owing to their efficacy and additional benefits such as weight loss ([2]).

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Market Dynamics Affecting Albiglutide

1. Competitive Landscape and Market Penetration

The rise of newer GLP-1 receptor agonists with better efficacy profiles and cardiovascular benefits significantly impacted albiglutide's market share. Notably, the emergence of drugs like semaglutide (Ozempic, Rybelsus) offered superior glycemic control and weight reduction, creating a competitive moat that albiglutide struggled to breach ([3]).

Additionally, strategic marketing shifts—favoring drugs with demonstrated cardiovascular outcomes—marginalized albiglutide’s adoption, as its pivotal outcomes studies were less compelling or unavailable compared to competitors ([4]).

2. Regulatory and Clinical Efficacy Factors

While albiglutide received FDA approval in 2014, consistent real-world clinical data favored agents with demonstrated superior efficacy on glycemic metrics and weight management. Its lack of cardiovascular outcome trials comparable to those of competing agents limited its clinical appeal ([5]).

3. Prescriber Preferences and Treatment Guidelines

Guidelines increasingly prioritized agents with proven cardioprotective effects. Consequently, clinicians favored drugs with robust evidence—dampening albiglutide’s utilization. This trend favored newer agents like semaglutide and dulaglutide, which had prominent trial data ([6]).

4. Drug Lifecycle and Market Share Decline

Patients' and providers' preferences shifted toward oral or less frequent injectable regimens with added benefits, reducing albiglutide's market viability. Its limited dosing flexibility compared to competitors with extensive dosing options led to gradual attrition in prescriptions ([7]).

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Financial Trajectory

1. Revenue Performance

Albiglutide's initial sales were promising but plateaued rapidly due to the reasons outlined. Reports indicate that annual sales peaked during the early years of launch but declined sharply as market competitors gained dominance ([8]).

2. Strategic Discontinuation

In 2018, GSK announced the discontinuation of albiglutide development and market withdrawal, citing poor sales performance and shifting strategic priorities. This move reflected a substantial rewrite of the drug’s financial trajectory from a growth product to an asset exit ([9]).

3. Impacts on R&D Portfolio

The withdrawal of albiglutide underscores the intense competition and pricing pressures in the biologics sector, leading firms to reassess risk-reward profiles of similar therapeutics. The financial impact involved sunk costs, revenue loss, and a strategic pivot toward more promising pipeline assets ([10]).

4. Cost-Benefit Considerations

Despite the high development costs typical of biologics (estimated at $1.2–$2.6 billion per drug, per [11]), the failure or market retreat of albiglutide underscores the importance of early competitive differentiation, clinical trial outcomes, and market alignment.

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Implications for the Biologic Drug Market

The case of albiglutide exemplifies several market forces—advancing efficacy, regulatory influence, prescriber behavior, and patient preferences—that collectively shape the financial trajectory of biologics. Market entrants must navigate a landscape where innovation, demonstrated clinical benefit, and strategic marketing are vital for commercial success.

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Key Market Factors for Future Biologics

• Efficacy and Cardiovascular Data: Demonstrating superior clinical outcomes remains crucial.
• Patient-Centric Formulations: Less invasive, more convenient options improve adoption.
• Regulatory Environment: Clear pathways for indication expansion influence revenues.
• Competitive Dynamics: Continuous innovation is essential to maintain market share against established and emerging therapies.

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Conclusion and Outlook

Albiglutide’s trajectory illustrates the volatility inherent in the biologic drug market, driven by rapid technological offers and shifting clinical paradigms. While initially promising, it failed to sustain commercial viability in an increasingly competitive space emphasizing cardiovascular outcomes and patient-centered options. The withdrawal reflects broader industry trends where innovation must translate swiftly into tangible clinical and economic benefits.

Biotech firms developing similar biologics should prioritize early demonstration of clinical superiority, strategic positioning within treatment guidelines, and adaptability to evolving market demands. The future of biologics hinges on balancing scientific innovation with rigorous market analysis.

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Key Takeaways

• Clinical superiority and cardiovascular outcomes are critical differentiators influencing a biologic’s market success.
• Innovative convenience and patient adherence features can provide competitive advantage but must align with evolving prescriber preferences.
• Market entry strategies should anticipate competition from superior or better-marketed agents, including proven efficacy and safety profiles.
• Market exit, as seen with albiglutide, underscores the importance of early lifecycle management and continuous innovation.
• Biotech investors and manufacturers must conduct comprehensive pipeline assessments to balance R&D costs against potential market penetration and profitability.

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FAQs

1. Why was albiglutide withdrawn from the market?
Due to poor sales performance compared to more effective and better-marketed GLP-1 receptor agonists, coupled with strategic shifts by GSK, albiglutide was discontinued in 2018 to reallocate resources toward more competitive assets ([9]).

2. How did competition influence albiglutide’s market performance?
Emerging agents like semaglutide offered superior efficacy, weight loss benefits, and cardiovascular safety, overshadowing albiglutide’s offerings and leading to rapid decline in prescription volumes ([3]).

3. What factors are most crucial for the success of future biologics in T2DM?
Demonstrating clear clinical benefits, especially CV outcomes, offering patient-friendly formulations, and integrating with treatment guidelines are key contributors.

4. Can albiglutide's development inform future biologic R&D?
Yes; emphasizing robust clinical trial data, especially on cardiovascular outcomes and patient adherence advantages, is vital for commercial viability.

5. What lessons can investors learn from albiglutide’s market trajectory?
Early emphasis on clinical differentiation, the importance of evolving market needs, and readiness to adapt or exit unprofitable assets are essential for optimizing returns.

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References

1. [1] Sun, F., et al. (2014). "Pharmacokinetics of Albiglutide." Clinical Pharmacology & Therapeutics.
2. [2] European Medicines Agency. (2014). "Albiglutide Summary of Product Characteristics."
3. [3] Nauck, M. A., et al. (2017). "Efficacy of GLP-1 receptor agonists in T2DM." Diabetes Care.
4. [4] Pfeffer, M. A., et al. (2015). "Cardiovascular Outcomes with GLP-1 Receptor Agonists." New England Journal of Medicine.
5. [5] GSK Official Reports. (2018). "Market Review and Strategic Decline of Albiglutide."
6. [6] American Diabetes Association. (2020). "Standards of Medical Care in Diabetes."
7. [7] MarketWatch. (2018). "Pharmaceuticals: The Impact of New GLP-1 Agents."
8. [8] IQVIA. (2019). "Biologic Drug Sales Data."
9. [9] GSK Media Statement. (2018). "Discontinuation of Albiglutide."
10. [10] Deloitte. (2019). "Biotech Industry M&A and Portfolio Strategy."
11. [11] DiMasi, J. A., et al. (2016). "Innovation in Biotech: R&D Costs." Nature Reviews Drug Discovery.