Ustekinumab-auub - Biologic Drug Details

Summary for ustekinumab-auub

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

Pharmacology for ustekinumab-auub

Mechanism of Action	Interleukin-12 Antagonists Interleukin-23 Antagonists
Established Pharmacologic Class	Interleukin-12 Antagonist Interleukin-23 Antagonist

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 ustekinumab-auub Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ustekinumab-auub Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ustekinumab-auub Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Ustekinumab (Stelara)

Introduction

Ustekinumab, marketed under the brand name Stelara by Johnson & Johnson, is a human monoclonal antibody used to treat various autoimmune diseases, including moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis. The market for ustekinumab is undergoing significant changes with the emergence of biosimilars, which are set to reshape the financial and competitive landscape of this biologic drug.

Market Size and Forecast

The ustekinumab market was valued at USD 11.4 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.90% to reach USD 18.03 billion by 2031. This growth is driven by increasing global healthcare expenditure, particularly in developed and emerging nations, and strategic partnerships among pharmaceutical companies to broaden their product offerings and create new indications[3].

Biosimilar Approvals and Launches

Several biosimilars of ustekinumab have been approved or are set to launch in the near future. As of 2023, four biosimilars have been approved:

• Wezlana by Amgen, approved on November 1, 2023, with an interchangeability designation and set to launch no later than January 1, 2025[2].
• Selarsdi by Alvotech[2].
• Pyzchiva by Samsung Bioepis, also granted the interchangeability designation[2].
• Otulfi (ustekinumab-aauz) by Formycon and Fresenius Kabi, approved in September 2024 and set to launch in February 2025[2].

These biosimilars are expected to significantly impact the market dynamics and pricing strategies for ustekinumab.

Impact of Biosimilars on Market Share and Pricing

The introduction of biosimilars typically leads to a reduction in the average sales price (ASP) of the reference product and its biosimilars. For example, in the markets for other biologics like trastuzumab and bevacizumab, the biosimilar share has led to substantial price erosion. Similarly, the launch of ustekinumab biosimilars is anticipated to increase competition and reduce prices.

Pricing Strategies

The entry of multiple biosimilars in a short timeframe is likely to create various pricing strategies, similar to what was observed with the launch of adalimumab biosimilars. This competition will provide physicians and patients with more treatment options and potentially lower costs[4].

Market Share

The staggered release of biosimilars, managed by Johnson & Johnson through settlements, will allow different manufacturers to capture market share at different times. This strategy could mitigate the immediate impact of price erosion but will ultimately lead to increased competition and lower prices as more biosimilars enter the market[4].

Financial Implications for Johnson & Johnson

The approval and launch of biosimilars pose a significant financial challenge for Johnson & Johnson. Stelara generated $10.8 billion in worldwide sales in 2023, with $6 billion of that coming from the US market. The erosion of market share and prices due to biosimilars will likely reduce these revenues.

Revenue Impact

The launch of biosimilars will lead to a decline in Stelara's market share and ASP. For instance, in the trastuzumab market, the ASP has dropped by 70% with the introduction of biosimilars. A similar trend is expected for ustekinumab, which could significantly reduce Johnson & Johnson's revenue from Stelara[1].

Strategic Responses by Pharmaceutical Companies

Pharmaceutical companies are adopting various strategies to mitigate the impact of biosimilars and maintain market share:

Diversification and Partnerships

Companies like Amgen are investing heavily in the development of biosimilars for other biologic drugs, such as Humira and Eylea, to diversify their product portfolios and maintain revenue streams. Strategic partnerships and collaborations are also being pursued to create new indications and boost market penetration[5].

Innovation and Differentiation

To remain competitive, companies may focus on innovation, such as improving delivery devices and product formulations. These differentiators can impact the success of biosimilar launches and help companies retain market share[4].

Patient and Physician Perspectives

The increased availability of biosimilars will provide patients with more affordable treatment options. Physicians will have a broader range of choices, allowing them to select the most appropriate treatment based on factors such as price, formulation, and delivery devices.

Regulatory Environment

Regulatory approvals and interchangeability designations play a crucial role in the market dynamics of biosimilars. The FDA's approval process and the granting of interchangeability designations can significantly influence the market share and pricing strategies of biosimilars[2].

Conclusion

The market for ustekinumab is on the cusp of significant changes driven by the approval and launch of multiple biosimilars. These changes will lead to increased competition, reduced prices, and a shift in market share. Pharmaceutical companies are adapting through diversification, strategic partnerships, and innovation to maintain their market presence.

Key Takeaways

• The ustekinumab market is projected to grow to USD 18.03 billion by 2031.
• Four biosimilars of ustekinumab have been approved, with launches scheduled for 2025.
• Biosimilars are expected to reduce the ASP and market share of the reference product, Stelara.
• Pharmaceutical companies are diversifying and forming strategic partnerships to maintain market share.
• Innovation in delivery devices and product formulations will be key differentiators.

FAQs

Q: What is the current market size of ustekinumab?

The ustekinumab market was valued at USD 11.4 billion in 2023.

Q: How many biosimilars of ustekinumab have been approved?

As of 2024, four biosimilars of ustekinumab have been approved.

Q: When are the ustekinumab biosimilars set to launch?

The biosimilars are set to launch in early 2025, with Wezlana launching no later than January 1, 2025, and Otulfi launching in February 2025.

Q: What is the expected impact of biosimilars on the ASP of ustekinumab?

The introduction of biosimilars is expected to lead to a significant reduction in the ASP of ustekinumab, similar to what has been observed in other biologic markets.

Q: How are pharmaceutical companies responding to the entry of biosimilars?

Pharmaceutical companies are diversifying their product portfolios, forming strategic partnerships, and focusing on innovation to maintain market share.

Sources

1. Samsung Bioepis, Biosimilar Market Dynamics - SAMSUNG BIOEPIS, Q3 2024.
2. Center for Biosimilars, Fourth Ustekinumab Biosimilar, Otulfi, Approved in US, September 30, 2024.
3. Verified Market Research, Ustekinumab Market Size, Scope, Share, Trends & Forecast.
4. MMIT Network, Biosimilar Market Has Had Tremendous Year, With No Signs of Slowing, November 16, 2023.
5. DelveInsight, Is Amgen's Biosimilar Wezlana a Competitor for J&J's Stelara?, December 1, 2023.

Last updated: 2024-12-22