Adalimumab-ryvk - Biologic Drug Details

Summary for adalimumab-ryvk

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

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 adalimumab-ryvk Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for adalimumab-ryvk Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for adalimumab-ryvk Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Adalimumab (Humira and Its Biosimilars)

Introduction to Adalimumab

Adalimumab, marketed under the brand name Humira by AbbVie, is a monoclonal antibody therapeutic that targets TNF-alpha, a pro-inflammatory cytokine involved in several immune-mediated conditions such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Since its FDA approval in 2002, Humira has been one of the most successful biologic drugs globally.

Market Share and Competition

As of May 2024, Humira's market share has significantly declined. According to Samsung Bioepis, Humira's market share dropped to 82%, a 13% decrease since March 2024. This decline is largely attributed to the increasing presence of biosimilars in the market[1][4].

Biosimilar Entrants

Several biosimilars have entered the U.S. market, starting with Amgen’s Amjevita in January 2023. Other notable biosimilars include Celltrion’s Yuflyma, Boehringer Ingelheim’s Cyltezo, and Sandoz’s and Cordavis’ Hyrimoz. The latter has gained significant traction, controlling around 13% of the market as of May 2024[4].

Impact of Formulary Changes

A critical factor in the market share shift is the decision by CVS Caremark to remove Humira from its major national commercial formularies in April 2024. This move led to a substantial increase in new prescriptions for Hyrimoz, highlighting the importance of coverage and access in driving market dynamics[4].

Pricing and Cost Savings

Pricing has played a significant role in the adoption of biosimilars. Biosimilar brands offer diverse pricing options, with some providing steep discounts. For instance, Samsung Bioepis’ Hadlima and Coherus’ Yusimry are priced around 85% lower than Humira. Despite these discounts, pricing alone has not been the primary driver of Humira’s declining market share; rather, it is the combination of pricing and formulary coverage[4].

Financial Trajectory

Historical Revenue

Before the entry of biosimilars, Humira was a blockbuster drug, generating $20.6 billion in revenue in 2021. However, with the loss of key patent protections and the introduction of biosimilars, Humira’s global sales dipped by 32% to $14.4 billion in 2023[4].

Current and Projected Revenue

The global adalimumab market, including both the original biologic and its biosimilars, is expected to continue growing. The market is projected to register a growth rate of nearly 5.1% during the forecast period, driven by increasing age, prevalence of diseases, and rising healthcare expenditure in developed regions[3].

Biosimilar Impact on Revenue

The entry of biosimilars has significantly impacted Humira’s revenue. As biosimilars gain market share, the average sales price (ASP) of adalimumab products has decreased. For example, the ASP of biosimilars alone has dropped by 70% compared to the reference product’s ASP at the time of the first biosimilar launch[1].

Strategic Partnerships and Commercialization

Teva and Alvotech Partnership

Teva and Alvotech have formed a strategic partnership to commercialize biosimilars, including SIMLANDI, a high-concentration and citrate-free adalimumab biosimilar. This partnership aims to increase healthcare access and provide affordable high-quality biologics. SIMLANDI has gained FDA approval and interchangeability designation, which is expected to enhance its market penetration[2][5].

Patient Access and Affordability

Companies like Quallent Pharmaceuticals are working to improve patient access through copay assistance programs and other initiatives. These efforts are designed to make biosimilars more affordable and accessible to a broader patient population[2].

Market Trends and Future Outlook

Dominance of Lower-Priced Biosimilars

In the adalimumab market, lower-priced biosimilars are dominating the market share. This trend is expected to continue as more biosimilars enter the market and gain approval for interchangeability[1].

Regional Growth

North America remains a key region for growth, driven by heightened awareness of disease remittance therapies, rising prevalence of rheumatoid arthritis, and favorable reimbursement policies. Easy access to quality healthcare and a strong clinical pipeline also contribute to the region’s growth[3].

Regulatory Environment

The FDA’s approval and interchangeability designations for biosimilars have been crucial in shaping the market. As more biosimilars gain these designations, they are likely to further erode the market share of the original biologic, Humira[4].

Key Takeaways

• Market Share Shift: Humira’s market share has declined significantly due to the entry of biosimilars, with Hyrimoz being a major gainer.
• Pricing and Discounts: Biosimilars offer substantial discounts, but pricing is not the sole driver of market share changes.
• Formulary Changes: Coverage and access, influenced by formulary decisions, play a critical role in market dynamics.
• Financial Impact: Humira’s revenue has decreased with the introduction of biosimilars, while the overall adalimumab market is expected to grow.
• Strategic Partnerships: Collaborations between companies like Teva and Alvotech are crucial for the commercial success of biosimilars.
• Patient Access: Initiatives to improve affordability and access are key to expanding the biosimilar market.

FAQs

Q: What is the current market share of Humira in the adalimumab market?

A: As of May 2024, Humira's market share has dropped to 82%, a 13% decrease since March 2024[1][4].

Q: Which biosimilar has gained the most market share in the adalimumab market?

A: Sandoz’s and Cordavis’ Hyrimoz has gained around 13% of the market share, making it one of the leading biosimilars[4].

Q: How have formulary changes impacted the adalimumab market?

A: CVS Caremark’s decision to remove Humira from its major formularies led to a significant increase in prescriptions for biosimilars like Hyrimoz[4].

Q: What is the average sales price (ASP) trend for adalimumab biosimilars?

A: The ASP of biosimilars alone has dropped by 70% compared to the reference product’s ASP at the time of the first biosimilar launch[1].

Q: Which companies are partnering to commercialize adalimumab biosimilars?

A: Teva and Alvotech have formed a strategic partnership to commercialize biosimilars, including SIMLANDI, a high-concentration and citrate-free adalimumab biosimilar[2][5].

Sources

1. Samsung Bioepis, Biosimilar Market Dynamics, May 2024.
2. Teva Pharmaceuticals, U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira (adalimumab), April 30, 2024.
3. Mordor Intelligence, Adalimumab Drugs Market Size & Share Analysis, 2020-2025.
4. BioSpace, AbbVie's Humira Continues to Lose Market Share as Biosimilars Gain Ground, July 12, 2024.
5. Teva Pharmaceuticals, Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S., May 20, 2024.

Last updated: 2024-12-17