Adalimumab-adbm - Biologic Drug Details

Summary for adalimumab-adbm

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-adbm Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Adalimumab (Adalimumab-abdm)

Introduction to Adalimumab

Adalimumab, marketed under the brand name Humira by AbbVie, is a biologic drug used to treat various autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and Crohn's disease. The drug has been a blockbuster for AbbVie, but the landscape is changing with the introduction of biosimilars.

Market Share and Uptake of Biosimilars

In recent years, the market share of adalimumab biosimilars has seen a significant surge. As of early 2024, biosimilars held only about 2% of the market share, but this has rapidly increased to 22% by the end of the year. This growth is largely driven by the uptake of biosimilars through private label brands and strategic moves by pharmacy benefit managers (PBMs)[1][2].

Role of Pharmacy Benefit Managers (PBMs)

PBMs have played a crucial role in the uptake of adalimumab biosimilars. For instance, CVS Caremark removed Humira from its national commercial template formularies and replaced it with three Sandoz biosimilars, including Hyrimoz. This move has significantly boosted the uptake of Hyrimoz, with biosimilar adalimumabs now making up about 15% of the total Humira market[2].

Financial Impact and Cost Savings

The introduction of biosimilars has led to substantial cost savings for both patients and plan sponsors. For example, Evernorth expects an annual savings of $3,500 per person by switching to a biosimilar, which is priced approximately 85% lower than Humira’s list price[2].

FDA Approvals and Market Expansion

As of September 2024, the FDA has approved 61 biosimilars across 17 molecules, with 41 of these biosimilars launched in the US market. This includes multiple adalimumab biosimilars, such as Amgen’s Amjevita, Sandoz’s Hyrimoz, and Alvotech and Teva’s Simlandi. The average sales prices (ASPs) of all biosimilars have decreased by 53% over the first five years post-launch[1].

Global Market Outlook

The global HUMIRA (adalimumab) drug market is expected to witness significant growth from 2024 to 2032, driven by the increasing prevalence of autoimmune diseases and the growing adoption of biologic drugs. North America dominates this market, followed by Europe and the Asia Pacific region, which is expected to grow at the highest CAGR during the forecast period[3].

Challenges and Opportunities

Despite the growth, the market faces challenges such as the high cost of clinical trials and research and development. Manufacturers must balance heavy R&D spending with the need to keep product prices low, which can limit growth opportunities. However, government initiatives, optimal costs, and increased R&D expenditure in biopharmaceutical companies are stimulating market development[3].

Patient Retention and Brand Loyalty

AbbVie’s Humira has shown resilience in retaining patients despite the availability of lower-priced biosimilars. Humira retained more than 80% of its patients from Q3/2023 to Q2/2024, raising questions about the long-term viability of the biosimilar market in its current form[4].

Future Trends and Strategies

Looking ahead, other PBMs are likely to follow the strategies of CVS and Cigna in promoting biosimilars to optimize cost savings. Optum Rx, for example, will remove several Humira biosimilars from its formulary in 2025, emphasizing affordability and significant cost reduction for plan sponsors[5].

Impact of COVID-19

The COVID-19 pandemic has affected the HUMIRA drug market with disruptions in supply chain and manufacturing activities. However, the market is expected to recover in the post-pandemic period, driven by increasing demand for effective treatments for autoimmune diseases[3].

Emerging Drugs and Competition

Emerging drugs like IBI303 and CT-P17 are set to enter the market, further increasing competition. This competition is expected to drive innovation and potentially lower prices, benefiting patients and healthcare systems[3].

Key Players in the Market

The global HUMIRA (adalimumab) drug market includes key players such as AbbVie Inc., Amgen Inc., Fresenius Kabi AG, Celltrion Healthcare Co Ltd, Alvotech Ehf., and others. These companies are investing heavily in research and development to maintain their market positions[3].

Key Takeaways

• Rapid Uptake of Biosimilars: Adalimumab biosimilars have seen a significant increase in market share, driven by PBM strategies and private label brands.
• Cost Savings: Biosimilars offer substantial cost savings, with prices up to 85% lower than Humira’s list price.
• Global Market Growth: The global HUMIRA market is expected to grow significantly from 2024 to 2032, driven by increasing prevalence of autoimmune diseases.
• Challenges and Opportunities: High R&D costs and supply chain disruptions are challenges, but government initiatives and increased R&D expenditure are driving market growth.
• Future Trends: Other PBMs are likely to adopt strategies similar to CVS and Cigna to promote biosimilars and optimize cost savings.

FAQs

Q: What is the current market share of adalimumab biosimilars?

A: As of 2024, adalimumab biosimilars have increased their market share from 2% to 22%, driven largely by biosimilar uptake through private label brands and PBM strategies[1].

Q: How have PBMs influenced the uptake of adalimumab biosimilars?

A: PBMs like CVS Caremark have removed Humira from their formularies and replaced it with biosimilars, significantly boosting the uptake of biosimilars such as Hyrimoz[2].

Q: What are the expected cost savings from switching to adalimumab biosimilars?

A: Switching to biosimilars can result in annual savings of up to $3,500 per person, with biosimilars priced approximately 85% lower than Humira’s list price[2].

Q: How has the COVID-19 pandemic affected the HUMIRA drug market?

A: The pandemic has caused disruptions in supply chain and manufacturing activities, but the market is expected to recover in the post-pandemic period driven by increasing demand for treatments[3].

Q: Which regions are expected to drive the growth of the HUMIRA market?

A: North America currently dominates the market, but the Asia Pacific region is expected to grow at the highest CAGR during the forecast period due to increasing awareness and healthcare expenditure[3].

Sources

1. Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share. Center for Biosimilars.
2. PBM Moves Spur Humira Biosimilar Uptake but Raise Questions. PSG Consults.
3. HUMIRA (Adalimumab) drug Market Research, Size, Share, 2032. Expert Market Research.
4. Humira's resilience in the face of biosimilar competition. GaBI Online.
5. Optum Rx Switches Up Humira Biosimilar Coverage for 2025. Managed Healthcare Executive.