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Last Updated: March 24, 2025

Ocrelizumab - Biologic Drug Details


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Summary for ocrelizumab
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
Recent Clinical Trials: See clinical trials for ocrelizumab
Recent Clinical Trials for ocrelizumab

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Fondation Ophtalmologique Adolphe de RothschildPhase 3
Stichting TreatmedsPhase 3
Amsterdam UMC, location VUmcPhase 3

See all ocrelizumab clinical trials

Pharmacology for ocrelizumab
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 ocrelizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of Ocrelizumab (Ocrevus)

Introduction to Ocrelizumab (Ocrevus)

Ocrelizumab, marketed as Ocrevus, is a biologic drug developed by Roche, in collaboration with Biogen, for the treatment of multiple sclerosis (MS). It is the first FDA-approved treatment targeting CD20-positive B cells and has been a game-changer in the MS therapeutic landscape since its launch in 2017[4].

Market Leadership and Growth

Ocrevus has consistently demonstrated strong market leadership and growth. In 2023, it generated over $7 billion in revenue for Roche, marking a 12% increase from 2022. This steady growth trajectory is a testament to the drug's efficacy, convenient dosing, and competitive pricing[1].

Competitive Landscape

Since Ocrevus entered the market, several other MS therapies have been approved, but none have matched its growth trajectory. The drug's broad MS label, impressive clinical results, and lack of a black box warning have contributed to its dominance. New drugs, such as MedDay’s biotin formulation MD-1003 and Novartis’s siponimod, are in development but have yet to pose a significant threat to Ocrevus's market position[4].

Pricing Strategy

Ocrevus was launched with an annual wholesale acquisition cost (WAC) of $65,000, which was 25% less than Rebif and nearly 20% less than the average WAC for MS medications at the time. As of 2023, the WAC has increased to $75,102 per year but remains approximately 28% less than the average price for other MS medications. This attractive pricing has been praised by the National MS Society and has helped in maintaining its market appeal[3][4].

Cost-Effectiveness Analysis

Studies have shown that Ocrevus is cost-effective compared to other MS treatments. An Analysis Group study published in the Journal of Medical Economics found that over a 20-year period, Ocrevus resulted in lower total costs due to reduced expenses associated with treatment, monitoring, adverse events, and relapses. Additionally, Ocrevus performed better in terms of quality-adjusted life years and years lived compared to subcutaneous interferon beta-1a[5].

Budgetary Impact

A detailed budgetary impact analysis, such as the one conducted for alemtuzumab, highlights the financial benefits of using targeted therapies like Ocrevus. While the specific analysis for Ocrevus is not provided in the same detail, it is clear that such therapies can lead to significant cost savings over time. For example, the analysis on alemtuzumab shows a decreasing trend in budgetary impact starting from the third year, indicating potential long-term cost benefits for similar targeted treatments[2].

Revenue Performance

Ocrevus has exceeded initial sales forecasts. By 2023, it had surpassed the projected annual sales of over $4 billion, making it one of the biggest blockbuster entrants in the pharmaceutical market. The fourth quarter of 2023 saw a notable increase in sales, with $1.9 billion in revenue, further solidifying its position in the MS market[1][4].

Clinical Efficacy and Patient Outcomes

The clinical efficacy of Ocrevus has been a key driver of its success. It has shown significant reductions in relapse rates and progression of disability in patients with relapsing and primary progressive MS. This high efficacy, combined with its convenient dosing regimen, has improved patient outcomes and adherence to treatment[4].

Potential Risks and Challenges

Despite its success, Ocrevus is not without challenges. The drug carries a potential risk of malignancy, as observed in the ORATORIO study, which is noted on its label. This risk may affect uptake in some cases. Additionally, the MS market is dynamic, with new drugs and generics entering the market, which could potentially impact Ocrevus's market share in the future[4].

Future Outlook

Ocrevus is forecast to continue dominating the MS market due to its strong clinical profile, competitive pricing, and broad label. However, the market will continue to evolve with new treatments and generics. The ability of Ocrevus to maintain its market position will depend on its continued performance and the response to emerging competitors[4].

Impact on Healthcare Systems

The use of Ocrevus can have a significant impact on healthcare systems. By reducing the costs associated with treatment, monitoring, and managing adverse events, Ocrevus can help in managing the overall healthcare expenditure. This is particularly important for chronic conditions like MS, where long-term management is crucial[5].

Patient and Payer Perspectives

From a patient perspective, Ocrevus offers a highly effective treatment option with a convenient dosing schedule. For payers, the cost-effectiveness of Ocrevus over the long term makes it an attractive option for reimbursement. The National MS Society has praised the drug for its value, further supporting its adoption[3][4].

Regulatory and Market Trends

The regulatory environment and market trends will continue to influence the trajectory of Ocrevus. As new drugs enter the market and generics become more prevalent, regulatory approvals and pricing strategies will play critical roles in maintaining market dominance. The ongoing development of new MS treatments and the potential for biosimilars will also shape the future landscape[4].

Key Takeaways

  • Market Leadership: Ocrevus has consistently led the MS market since its launch in 2017.
  • Revenue Growth: The drug generated over $7 billion in revenue in 2023, with a 12% increase from 2022.
  • Competitive Pricing: Ocrevus is priced competitively, with a WAC of $75,102 per year, which is 28% less than the average for other MS medications.
  • Cost-Effectiveness: Studies have shown that Ocrevus is cost-effective over the long term compared to other MS treatments.
  • Clinical Efficacy: The drug has demonstrated high efficacy in reducing relapse rates and progression of disability.
  • Future Outlook: Ocrevus is expected to continue dominating the MS market, though it will face challenges from new treatments and generics.

FAQs

What is Ocrevus used for?

Ocrevus (ocrelizumab) is used for the treatment of multiple sclerosis (MS), specifically targeting CD20-positive B cells. It is approved for both relapsing and primary progressive MS.

How much does Ocrevus cost?

As of 2023, the annual wholesale acquisition cost (WAC) of Ocrevus is $75,102, which is approximately 28% less than the average price for other MS medications.

Is Ocrevus cost-effective?

Yes, studies have shown that Ocrevus is cost-effective over the long term. It reduces costs associated with treatment, monitoring, adverse events, and relapses compared to other MS treatments.

What are the potential risks associated with Ocrevus?

Ocrevus carries a potential risk of malignancy, as observed in clinical trials, which is noted on its label.

How does Ocrevus compare to other MS treatments?

Ocrevus has shown higher efficacy and a more convenient dosing schedule compared to many other MS treatments. It also has a competitive pricing strategy that makes it an attractive option for both patients and payers.

Sources

  1. BioCentury - Ocrevus continues steady growth trajectory in 2023
  2. PMC - The budgetary impact of alemtuzumab in multiple sclerosis in Quito
  3. Oregon Prescription Drug Affordability Board - October 13, 2023 Public Comment
  4. Clarivate - Roche's Ocrevus to dominate the multiple sclerosis market
  5. Analysis Group - Cost-effectiveness analysis of ocrelizumab versus subcutaneous interferon beta-1a for the treatment of relapsing multiple sclerosis

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