Obinutuzumab - Biologic Drug Details

Summary for obinutuzumab

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

Recent Clinical Trials for obinutuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
City of Hope Medical Center	PHASE2
Radboud University Medical Center	PHASE2

See all obinutuzumab clinical trials

Pharmacology for obinutuzumab

Mechanism of Action	CD20-directed Antibody Interactions
Established Pharmacologic Class	CD20-directed Cytolytic 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. 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 obinutuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for obinutuzumab 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
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2035-01-08	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2035-02-20	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2036-12-01	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2037-12-06	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for obinutuzumab 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.	GAZYVA	obinutuzumab	Injection	125486		2035-01-08	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2035-02-20	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2036-12-01	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486		2037-12-06	Patent claims search

International Patents for obinutuzumab

Country	Patent Number	Estimated Expiration
Norway	347530
Spain	2708095
Portugal	2380911
Brazil	PI0416262

Supplementary Protection Certificates for obinutuzumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2016006,C2380910	Lithuania		PRODUCT NAME: OBINUTUZUMABAS; REGISTRATION NO/DATE: EU/1/14/937 20140723
2016C/008	Belgium		PRODUCT NAME: OBINUTUZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/14/937 20140724
CR 2016 00003	Denmark		PRODUCT NAME: OBINUTUZUMAB; REG. NO/DATE: EU/1/14/937 20140724
C 2016 006	Romania		PRODUCT NAME: OBINUTUZUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/14/937; DATE OF NATIONAL AUTHORISATION: EU/1/14/937; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DATA NOTIFICARII 24.07.2014 EU/1/14/937; DATE OF FIRST AUTHORISATION IN EEA: 20140723

Market Dynamics and Financial Trajectory for Obinutuzumab

Last updated: December 10, 2025

Executive Summary

Obinutuzumab (Gazyva, Gazyvaro), developed by Roche/Genentech, represents a significant advancement in the biologic oncology space. As a glycoengineered anti-CD20 monoclonal antibody, it primarily targets B-cell malignancies, including chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). Its market trajectory is shaped by evolving clinical efficacy, competitive landscape, regulatory approvals, and payer dynamics. Anticipated growth is underpinned by expanding indications and increasing adoption in frontline treatment settings, with projections suggesting a compound annual growth rate (CAGR) of approximately 12-15% through 2030. This analysis explores the market drivers, competitive environment, regulatory landscape, and financial outlook for obinutuzumab.

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What Are the Key Market Drivers for Obinutuzumab?

Clinical Efficacy and Differentiation

• Enhanced Antibody-Dependent Cellular Cytotoxicity (ADCC): Obinutuzumab’s glycoengineering improves binding to FcγRIIIa receptors, resulting in increased ADCC compared to rituximab.
• Approval in Multiple Indications: Approved for CLL and follicular lymphoma, with ongoing trials in diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies.
• Superior Progression-Free Survival (PFS): Clinical trials demonstrate improved PFS over rituximab-based therapies, influencing stage-specific treatment regimens.

Regulatory Milestones and Approvals

Year	Approval Body	Indication	Key Notes
2013	FDA	CLL, FL	First approval in relapsed or refractory settings
2014	EMA	Similar	Broader European approval with expanded indications

Growing Adoption in Oncology Treatment Paradigms

• Frontline Combinations: Incorporation in chemoimmunotherapy regimens as a preferred anti-CD20 agent.
• Combination with Targeted Therapies: Trials with ibrutinib, venetoclax, and others expand its usage.

Market Expansion Potential

• Emerging Indications: Trials in other B-cell malignancies, autoimmune conditions.
• Biologic Biosimilars: Entry into biosimilar markets could influence pricing and accessibility, impacting revenue forecasts.

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What Is the Competitive Landscape for Obinutuzumab?

Key Competitors

Product	Developer	Mechanism	Indications	Market Share (2022)
Rituximab	Roche/Genentech	Chimeric anti-CD20	Multiple B-cell malignancies	~70% in B-cell NHL
Ofatumumab	Novartis	Fully human anti-CD20	CLL, MS	Niche competitor
Obinutuzumab	Roche	Glycoengineered anti-CD20	CLL, FL	Growing share

Differentiators and Challenges

• Efficacy: Obinutuzumab shows improved PFS in specific settings.
• Safety Profile: Higher rates of infusion-related reactions (IRRs) compared to rituximab, managed with premedication.
• Biologic Cost and Pricing: Higher manufacturing costs; premium pricing in certain indications.
• Biosimilars: Potential erosion of market share should biosimilars enter at a competitive price point.

Market Share Dynamics

Year	Obinutuzumab	Rituximab	Market Share (Est.)	Notes
2020	10%	75%	-	After initial approval, gaining in niche indications
2025	25%	50%	-	Expected increase due to expanded use and new approvals

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How Is the Regulatory Environment Shaping the Market?

US and European Approvals

• US FDA: Evolving labeling; approvals for specific combinations.
• EMA/EMA-Approved Indications: Similar trends, with flexibility to expand into new territories.

Regulatory Incentives

• Orphan Drug Status: Granted in certain indications, enabling market exclusivity.
• Accelerated Programs: For promising indications, reducing time-to-market.

Impact of Policies

• Pricing Regulations: Increasing emphasis on value-based pricing may influence revenue.
• Reimbursement Policies: Coverage decisions depend on demonstrated clinical benefit over competitors.

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What Are the Financial Projections for Obinutuzumab?

Revenue Forecasts and Growth Drivers

Year	Estimated Revenue	CAGR	Key Factors
2022	~$1.2 billion	—	Market penetration, existing approvals
2025	~$2.0 billion	~13%	Indication expansion, new combinations
2030	~$3.4 billion	~15%	Broader label, competition management

Cost Structure and Pricing

Component	Description	Impact on Revenue
Manufacturing	Glycoengineering and monoclonal antibody production	High fixed cost, economies of scale critical
Pricing	Premium pricing in early adoption phase	Influenced by clinical benefit and competition
R&D	Ongoing trials for new indications	Investment sustains pipeline growth

Investment and Licensing Trends

• Leveraging partnerships for global distribution.
• Investment in biosimilar development to mitigate revenue erosion.

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Comparison: Obinutuzumab vs. Rituximab

Parameter	Obinutuzumab	Rituximab	Notes
Approval Year	2013	1997	Older drug, established market
Engineering	Glycoengineered	Chimeric	Enhanced efficacy, higher IRRs
Indications	Multiple, expanding	Broad, longstanding	Cost and branding impact adoption
Efficacy	Superior in some settings	Proven, extensive data	Specific advantages may influence line positioning
Cost	Higher	Lower	Price sensitivity impacts uptake

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What Is the Future Outlook for Obinutuzumab?

Emerging Trends and Opportunities

• New Indications: DLBCL, autoimmune diseases.
• Combination Therapies: With BTK inhibitors, CAR-T, and bispecific antibodies.
• Biotech Innovations: Engineering next-generation anti-CD20 agents.

Risks and Challenges

• Market Penetration: Competition from biosimilars and novel agents.
• Pricing Pressure: Payor negotiations and healthcare policies.
• Regulatory Delays: New indications require extensive clinical trials.

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Key Takeaways

• Obinutuzumab continues to grow as a key player in B-cell malignancy treatment, driven by its efficacy and expanding label.
• Competition from rituximab and biosimilars poses a challenge; differentiation hinges on clinical benefits and cost management.
• The outlook remains optimistic with a projected CAGR of 13-15% through 2030, supported by new indications and combination strategies.
• Regulatory and reimbursement policies will influence market share and revenue trajectory.
• Investors and stakeholders should monitor ongoing clinical trials, biosimilar development, and policy shifts to gauge future performance.

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FAQs

Q1: How does obinutuzumab’s mechanism differ from rituximab?
Obinutuzumab is glycoengineered to enhance FcγRIIIa binding, leading to increased ADCC. Rituximab is chimeric with standard Fc regions, resulting in potentially lower efficacy in some settings.

Q2: What are the main challenges facing obinutuzumab’s market growth?
Market challenges include competition from biosimilars, higher manufacturing costs, safety considerations such as IRRs, and pricing pressures from payors.

Q3: Which indications are expected to drive the most revenue?
Currently, CLL and follicular lymphoma are primary revenue drivers, with future expansion into DLBCL and autoimmune conditions expected to boost growth.

Q4: How significant is biosimilar entry in this market?
Biosimilar proliferation could reduce prices and increase accessibility, impacting obinutuzumab’s premium pricing model and market share.

Q5: What factors could accelerate obinutuzumab’s adoption?
Demonstrated superiority in head-to-head trials, approval for new indications, favorable reimbursement policies, and successful combination regimens could enhance adoption rates.

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References

[1] US Food and Drug Administration (FDA). Gazyva prescribing information. 2013.
[2] European Medicines Agency (EMA). Summary of Product Characteristics for Gazyvaro. 2014.
[3] National Cancer Institute. Approved Drugs for B-cell Malignancies. 2022.
[4] EvaluatePharma. Oncology Biologics Market Forecast. 2022.
[5] Roche Annual Report. 2022.