REMICADE Drug Profile

Summary for Tradename: REMICADE

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for REMICADE
Recent Clinical Trials:	See clinical trials for REMICADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REMICADE

See drug prices for REMICADE

Recent Clinical Trials for REMICADE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	Phase 2/Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3
Maisonneuve-Rosemont Hospital	Phase 1/Phase 2

See all REMICADE clinical trials

Recent Litigation for REMICADE

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
Upsher-Smith Laboratories, LLC v. Xiamen LP Pharmaceutical Co., Ltd.	2023-02-23

See all REMICADE litigation

PTAB Litigation

Petitioner	Date
Dr. Reddy's Laboratories, Inc. et al.	2018-08-03
	2017-12-20
	2014-11-06

See all REMICADE litigation

Pharmacology for REMICADE

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker

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 REMICADE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for REMICADE 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
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772		2034-06-16	Patent claims search
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772		2032-12-21	Patent claims search
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772		2033-03-11	Patent claims search
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772		2033-08-13	Patent claims search
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772		2039-02-26	Patent claims search
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772		2031-03-09	Patent claims search
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772		2032-10-12	Patent claims search

REMICADE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: REMICADE

Introduction

REMICADE, a biologic drug developed by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, has been a cornerstone in the treatment of autoimmune diseases such as rheumatoid arthritis, plaque psoriasis, and Crohn's disease. However, with the expiration of its patent, the market has seen a significant shift towards biosimilars. Here, we delve into the market dynamics and financial trajectory of REMICADE and its biosimilars.

What are Biosimilars?

Biosimilars are biological products that are highly similar to an already FDA-approved drug, known as the reference biological product. They reflect no clinical and meaningful differences from the reference products in terms of safety, purity, efficacy, and effectiveness[1].

Market Growth and Projections

The REMICADE biosimilar market is experiencing rapid growth. As of 2022, the market valuation stood at USD 2212.86 million, and it is projected to grow at a CAGR of 35.9% until 2032, reaching a value of USD 47,549.77 million[1].

Key Drivers of Market Growth

Several factors are driving the growth of the REMICADE biosimilar market:

• Rising Incidence of Autoimmune Diseases: The increasing prevalence of diseases such as rheumatoid arthritis and plaque psoriasis is boosting demand for effective treatments like REMICADE biosimilars[1][4].
• Early Patent Expiry: The expiration of REMICADE's patent has opened the market to biosimilar competition, which is driving growth[1][4].
• Discounted Pricing: Biosimilars are generally priced lower than their branded counterparts, making them more attractive in cost-sensitive markets, particularly in Europe[1][4].
• Faster Approval Processes: Quicker approval procedures and the development of proper FDA-licensed manufacturing facilities are facilitating the adoption of biosimilars[4].

Regional Market Dynamics

Europe

Europe holds a dominant position in the global REMICADE biosimilar market and is expected to retain this dominance. The presence of top market players, rapid entry of biosimilars, and high adoption rates due to lower prices are key factors contributing to this dominance[1].

Asia Pacific

The Asia Pacific region is expected to present lucrative opportunities in the long run. Developments in healthcare infrastructure and the approval of REMICADE biosimilars by regional players are anticipated to drive growth in this region[1].

Financial Impact on Pharmaceutical Companies

The rise of biosimilars poses significant financial challenges for pharmaceutical companies that have traditionally relied on branded biologics like REMICADE.

Revenue Erosion

Companies like Johnson & Johnson have seen revenue erosion due to biosimilar competition. For instance, the sales revenue of REMICADE has been impacted by the introduction of biosimilars such as Inflectra, which grew from $192 million in 2016 to $642 million in 2018[3].

Strategic Responses

To mitigate the impact of biosimilar competition, pharmaceutical companies are investing in their own biosimilar products. For example, Amgen has developed biosimilars for drugs like infliximab, rituximab, and bevacizumab[3].

Innovation and Diversification

Companies are also focusing on follow-on innovations to maintain market share. Roche's subcutaneous formulation of Herceptin (trastuzumab) is a prime example, reducing treatment time and improving patient outcomes while maintaining profitability[3].

Financial Performance of Key Players

Johnson & Johnson

Johnson & Johnson reported significant financial results in 2023, but the impact of biosimilar competition on REMICADE sales is evident. The company's overall pharmaceutical sales grew, but specific product lines like REMICADE faced challenges due to biosimilar entry[5].

Market Trends and Emerging Opportunities

Biologics Boom

The global biologics market, including biosimilars, is expected to continue growing. By 2027, the biologics market is projected to reach $569.7 billion, up from $343 billion in 2021, with a growth rate of 9.2%[3].

Emerging Markets

Emerging markets such as China and Brazil are becoming increasingly important for biologic and biosimilar sales. These markets offer opportunities for growth due to their large patient populations and developing healthcare infrastructures[3].

Challenges and Opportunities

Competitive Pricing

The increasing competition from biosimilars is driving down prices, which can be both a challenge and an opportunity. While it reduces revenue for branded products, it also makes biologic treatments more accessible to a wider patient population[3].

Regulatory Environment

The regulatory environment is becoming more favorable for biosimilars, with quicker approval processes and more supportive policies. This is expected to further boost the adoption of REMICADE biosimilars[4].

Key Takeaways

• The REMICADE biosimilar market is projected to grow significantly, driven by rising autoimmune disease incidence, early patent expiry, and discounted pricing.
• Europe dominates the market, but the Asia Pacific region is expected to grow substantially.
• Pharmaceutical companies are adapting by investing in biosimilar production and follow-on innovations.
• The global biologics market, including biosimilars, is expected to continue its upward trend.
• Emerging markets offer new opportunities for growth.

FAQs

What is the projected growth rate of the REMICADE biosimilar market?

The REMICADE biosimilar market is projected to grow at a CAGR of 35.9% from 2022 to 2032[1].

Which region dominates the REMICADE biosimilar market?

Europe currently dominates the REMICADE biosimilar market and is expected to retain its dominance over the forecast period[1].

What are the key drivers of the REMICADE biosimilar market growth?

Key drivers include the rising incidence of autoimmune diseases, early patent expiry of the branded version, discounted pricing, and faster approval processes[1][4].

How are pharmaceutical companies responding to biosimilar competition?

Pharmaceutical companies are investing in their own biosimilar products and focusing on follow-on innovations to maintain market share[3].

What is the impact of biosimilars on the financial performance of pharmaceutical companies?

Biosimilars are causing revenue erosion for branded biologics, prompting companies to diversify and innovate to maintain profitability[3][5].

What are the emerging trends in the biologics market?

Emerging trends include the growth of biosimilars, increasing focus on emerging markets, and the importance of follow-on innovations to stay competitive[3].