A Single Arm, Phase II Open Label Trial to Investigate the Efficacy and Safety of Intra-dermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus

The purpose of this study is to determine whether Etanercept which is given through intradermal injection is effective in the treatment of discoid lupus erythematosus (DLE).
The investigators also would like to develop new tests to measure skin inflammation by scanning the affected skin using optical coherence tomography (OCT), thermography and laser doppler imaging (LDI) and taking photographs of the rash (to be done before and after treatment). If the findings from these new tests are similar to the ones from taking a sample of skin (biopsy), then the latter (which is an invasive test) can be avoided.

Start Date01 Feb 2016

Sponsor / Collaborator

University of Leeds

[+1]

EUCTR2012-002009-23-BG

/ Not yet recruitingPhase 3

A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA

Start Date25 Nov 2015

Sponsor / Collaborator

Hexal AG

NCT02638259

/ CompletedPhase 3

A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

Start Date21 Feb 2015

Sponsor / Collaborator

Sandoz AG

100 Clinical Results associated with Etanercept-SZZS(Sandoz Inc.)

100 Translational Medicine associated with Etanercept-SZZS(Sandoz Inc.)

100 Patents (Medical) associated with Etanercept-SZZS(Sandoz Inc.)

Literatures (Medical) associated with Etanercept-SZZS(Sandoz Inc.)

01 Jul 2024·BIODRUGS

Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly

Article

Author: Żuber, Zbigniew Michał ; Krajewska-Włodarczyk, Magdalena ; Batko, Krzysztof ; Stajszczyk, Marcin ; Batko, Bogdan ; Kwiatkowska, Brygida

OBJECTIVES:

To evaluate the pricing of etanercept (ETN) reference and biosimilar drugs in a changing competitive to monopolized market.

METHODS:

We conducted a comprehensive, retrospective analysis of ETN market competition, specifically changes in tender price based on shifts in market monopoly, including the effects on cost evolution, in the off-patent market in Poland. We included a total of 473 tenders for ETN purchase in dedicated biologic drug reimbursement programs, covering both pre-filled syringes and automatic injectors. This study covers the timeframe from November 2017 to December 2023, throughout which we evaluated a unique setting of ETN market re-monopolization from the perspective of payer, hospital and patient benefits resulting from changing cost calculations.

RESULTS:

Between 2017 and 2022, Erelzi was recorded as having the largest total tender volume (59%), with a mean price [per ETN daily defined dose (DDD)] of €7.28, followed by Enbrel (31%, €8.34) and Benepali (10%, €9.45), respectively. Over the last 6 months of waning market competition, the mean price for winning bids was estimated at €5.69. After market re-monopolization by an ETN biosimilar, the mean price of winning bids increased to €8.09, and continued to increase (€9.71) in the last 6 months of available follow-up. In contrast to the competitive era, no significant relationship between tender volume and winning price was recorded after re-monopolization. In the most recent tenders, mean ETN prices increased up to €15.82, nearly tripling the lowest prices of the competitive market period. In the early re-monopolization market, mean annual treatment cost per patient is estimated at over €3800, which exceeds therapy costs in the prior competitive market years, and is expected to increase to over €6200 based on the most recent tenders. On a healthcare system level, this corresponds to over €3.42 million excess costs due to market monopoly. Higher ETN prices resulted in downstream failure of regulatory incentives to promote affordable biologics. Due to higher pricing, hospitals lost over an estimated €2.52 million, with possible risk of treatment restrictions. For the same reason, the public payer achieved comparable savings, allowing for partial coverage of higher reimbursement expenses.

CONCLUSIONS:

This nation-level scenario of market re-monopolization by a biosimilar drug confirms net loss and excess costs for the healthcare payer, as can be expected from economic theory. The upwards drug repricing and restriction of treatment availability occurs much more rapidly than the decrement in a period of market competition.

01 Dec 2023·Drug safety

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

Review

Author: Cohen, Hillel P ; Kottke, Andrea ; Kalsekar, Sameer ; Anjaneya, Pradeep ; Sagi, Sreedhar

BACKGROUND:

Biosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still lingering concerns related to the long-term safety of biosimilars. Therefore, we reviewed the post-approval pharmacovigilance data for eight marketed biosimilars from one Marketing Authorization Holder (MAH) to summarize their safety experience in a real-world setting for up to 18 years since their first biosimilar launch.

METHODS:

Post-approval cumulative patient exposure and safety experience for eight Sandoz biosimilars [adalimumab (Hyrimoz^®), epoetin alfa (Binocrit^®), etanercept (Erelzi^®), filgrastim (Zarzio^®), infliximab (Zessly^®), pegfilgrastim (Ziextenzo^®), rituximab (Rixathon^®), and somatropin (Omnitrope^®)] was summarized based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding health authority-authored PSUR assessment reports, where available, as of 31 January 2023. Exposure to all biosimilars was calculated in patient treatment days (PTD) except for rituximab, which was expressed in number of patient doses (PD).

RESULTS:

The combined post-approval cumulative exposure to seven out of the eight marketed Sandoz biosimilars was more than 1.3 billion PTD and for rituximab more than 1.8 million PD. Overall, a critical analysis of the cumulative safety data of all eight Sandoz biosimilar PSURs concluded that the overall benefit-risk profile of each remains favorable and is consistent with the respective reference biologics.

CONCLUSIONS:

This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.

01 Jul 2022·TherapieQ4 · MEDICINE

Penetration rate of anti-TNF biosimilars and savings at 5 years after their introduction in French hospitals

Q4 · MEDICINE

Article

Author: Vallet, Catherine ; Trenque, Thierry ; Robinson, James ; Azzouz, Brahim ; Jolly, Damien ; Jarrion, Quentin

OBJECTIVE:

Since the expiry of the patents on originator anti-TNF agents in Europe, France has authorized the sale of biosimilars. The penetration rate of anti-TNF agents and their biosimilars, and the cost savings driven by the introduction of biosimilars appears to vary widely. This study aimed to describe the market share of anti-TNFs and their biosimilars, and the cost savings generated by the introduction of biosimilars in French hospitals 5 years ago.

METHODS:

The pharmaceutical component of the French national uniform hospital discharge data set database (PMSI) was used to study sales of infliximab, etanercept and adalimumab originators and biosimilars, and to estimate cost savings generated by the introduction of biosimilars onto the market, using the historical tariffs of the originators.

RESULTS:

The penetration rate of anti-TNF biosimilars in France in 76% for infliximab, 74% for etanercept and 77% for adalimumab. In 2020, Inflectra® (41%) was the Remicade® biosimilar with the highest sales volume, while Erelzi® (57%) and Amgevita® (64%) were the most widely sold biosimilars of Enbrel® and Humira® respectively. In terms of cost savings since the launch of biosimilars, overall, for all biosimilars taken together, over the 5-year period, a total of 824 million Euro was saved, in relation to the historical tariffs of the originators.

CONCLUSIONS:

This study shows firstly that the penetration rate of anti-TNF biosimilars in France 5 years after their launch is close to 80%. Secondly, we show that the cost savings generated by the use of biosimilars to anti-TNF agents exceed 820 million Euro over 5 years.

News (Medical) associated with Etanercept-SZZS(Sandoz Inc.)

14 Mar 2024

·www.prnewswire.com

Psoriasis in America - Insights into Psoriasis Patient Demographics, Quality of Life, Information-seeking Behaviors, HCP Engagement and Treatment Experiences

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Psoriasis in America 2023: Understanding the Psoriasis Patient Experience" report has been added to ResearchAndMarkets.com's offering. Approximately 7.5 million people in the United States have psoriasis. This Psoriasis in America report provides a comprehensive look at life for those living with psoriasis. Using detailed quantitative data, it gives a full picture of the psoriasis patient experience - from symptoms to treatment to HCP relationships to quality of life - so you can make informed, strategic decisions, identify opportunities, and understand potential challenges. The report offers an in-depth look at the psoriasis patient experience. This large-scale, patient-reported data leverages vital quantitative insights essential to understanding key touchpoints in the psoriasis patient journey, including condition management, HCP engagement, quality of life, treatment experience and satisfaction, and much more. This report lifts the curtain on life with psoriasis, giving stakeholders an actionable look at the behaviors, attitudes, perceptions, needs, and experiences of people living with the condition. Data can be used to inform strategic decisions, including product communications, competitive assessments, concept development, landscape analyses, patient journey overlays, and forecasting inputs. This report also addresses important questions that stakeholders may not even know to ask while offering valuable insights into must-have patient-reported data points not available anywhere else. Add-on custom data analysis opportunities are also available for an additional cost - please see the report following purchase for more information. The analyst reaches millions of people through its portfolio of 45+ condition-specific online health communities - including PlaquePsoriasis.com - to provide information, connection, and support to patients and caregivers in the U.S. This report includes a deep-dive into: Psoriasis patient demographics Age, gender, ethnicity, marital status, children, employment status, income, location, insurance, and other health conditions Impact of psoriasis on quality of life Severity, impact on quality of life, symptoms experienced, and what patients wish others better understood Information-seeking behaviors Information sources used, plus topics of interest HCP engagement Primary HCP seen for condition, satisfaction with HCP, and discussion about brands aware of/not used Psoriasis treatment awareness and experiences Aided awareness of specific treatments, treatment experience, satisfaction with current treatments, perceived control with current treatment plan, and interest/participation in clinical trials Key questions answered in this report: To what extent do people say psoriasis impacts their overall quality of life? What's the average number of flares in the past year? What do patients wish others understood about psoriasis? What percentage of patients see a specialist for psoriasis treatment? What treatments have the highest aided brand awareness among patients? What percentage of patients use a biologic? How many patients feel their psoriasis is well-controlled on their current treatment plan? What percentage of patients are likely to switch or add new treatments in the next six months? What medications have patients discussed with their HCP? What are the top online resources people with psoriasis use to find information? What kinds of content and information do patients search for? What percentage of patients search for information on treatment options? Methodology Psoriasis in America consists of: A 20-minute online quantitative survey, covering demographics, comorbidities, quality of life/impact, HCP interactions, as well as treatment awareness, experiences, and discussions Qualitative patient insights from open-ended responses Additional details: Fielded: January 16, 2023 to April 14, 2023 Convenience sample of 490 respondents diagnosed with psoriasis Respondents are age 18+, living in the U.S., and are recruited from proprietary online health communities and recruiting partners Key Topics Covered: Respondent Demographics Research Highlights Condition Status and Quality of Life Severity and Exacerbations Symptoms Experienced Impact on Quality of Life Qualitative Patient Insights Information-Seeking Behaviors Resources Used to Manage Health Types of Content/Information Sought Treatment Awareness and Experiences Primary HCP Seen for Psoriasis Care Aided Brand Awareness of Treatments Treatment Usage Condition Control on Current Treatment and Clinical Trial Interest Treatment Discussions with HCP Appendix with All Data Charts and Distributions Brands and treatments mentioned in this report include: Topical corticosteroid (such as hydrocortisone) BRYHALIT (halobetasol propionate) lotion DesOwen (desonide) SERNIVOT (betamethasone dipropionate) SORILUXT Foam (calcipotriene) TACLONEX (calcipotriene and betamethasone) TAZORAC (tazarotene) VECTICAL (calcitriol) VTAMA (tapinarof) ZITHRANOLT-RR (anthralin) ZORYVET (roflumilast) Acitretin (SORIATANE) ARAVA (leflunomide) Azathioprine (such as IMURAN, AZASAN) Cyclosporine (such as Sandimmune, NEORAL, RESTASIS) Methotrexate (eg, Rheumatrex), also sometimes given as an injection OTEZLA (apremilast) PLAQUENIL (hydroxychloroquine) RINVOQ (upadacitinib) SOTYKTUT (deucravacitinib) Sulfasalazine (Azulfidine) XELJANZ/XELJANZ XR (tofacitinib citrate) AMJEVITAT (adalimumab-atto) Hide until launched in US AVSOLA (infliximab-axxq) CIMZIA (certolizumab) COSENTYX (secukinumab) CYLTEZO (adalimumab-adbm) Hide until launched in US ENBREL (etanercept) ERELZIT (etanercept-szzs) Hide until launched in US HULIO (adalimumab-fkjp) Hide until launched in US HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) Hide until launched in US ILUMYAT (tildrakizumab-asmn) INFLECTRA (infliximab-dyyb) IXIFIT (infliximab-qbtx) Hide until launched in US ORENCIA (abatacept) REMICADE (infliximab) RENFLEXIST (infliximab-abda) SIMPONI (golimumab) SIMPONI ARIA (golimumab for infusion) SILIQT (brodalumab) SKYRIZI (risankizumab-rzaa) STELARA (ustekinumab) TALTZ (ixekizumab) TREMFYA (guselkumab) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

21 Nov 2023

·www.biospace.com

Sandoz launches Hyrimoz® (adalimumab) high-concentration formulation in Europe, aiming to improve patient care

Biosimilar Hyrimoz® (adalimumab) citrate-free high-concentration formulation (HCF) indicated for all conditions of reference medicine Humira®* Hyrimoz® HCF to launch progressively across Europe Hyrimoz® HCF strengthens well-established Sandoz biosimilar immunology portfolio in Europe Basel, November 21, 2023 – Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Hyrimoz® (adalimumab) citrate-free high concentration formulation (HCF; 100 mg/mL) in Europe. The medicine will become available to patients progressively across European markets, starting today. Hyrimoz® HCF, like the currently available 50mg/mL version of Hyrimoz®, is indicated for all conditions covered by the reference medicine*: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.1 Rebecca Guntern, President Europe Sandoz said: “People living with chronic inflammatory conditions can experience debilitating effects on daily life. The launch of Hyrimoz® HCF in Europe is a key milestone in offering an additional treatment option to those that need it and showcases our unwavering commitment to expanding access to high-quality medicines.” Hyrimoz® citrate-free HCF is an updated formulation (100 mg/mL) to the currently available Hyrimoz® 50 mg/mL and offers a 50 percent reduction in injection volume, thereby potentially decreasing the number of injections required for patients who need 80 mg/mL or higher dosing. The HCF formulation is administered with the familiar Hyrimoz® SensoReady® pen, aiming for an enhanced yet familiar patient experience. The launch of Hyrimoz ® HCF strengthens the Sandoz biosimilar portfolio in immunology, including Erelzi® (biosimilar etanercept), Zessly® (biosimilar infliximab) and Rixathon® (biosimilar rituximab, including rheumatoid arthritis indication). Hyrimoz® citrate-free HCF (adalimumab-adaz) launched in the US in July 2023. Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation. About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The adalimumab reference medicine (Humira®*) was first approved with an adalimumab concentration of 50 mg/mL.1 In 2015, the EMA and US FDA approved Humira® HCF, which contains adalimumab at a concentration of 100 mg/mL. Disclaimer This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. References EMA. Humira® EPAR Product Information. Available from: . [Accessed October 2023] *Humira® is a registered trademark of AbbVie Biotechnology Ltd # # # About Sandoz Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion. Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Joerg E. Allgaeuer +49 171 838 4838 Karen M. King +1 609 722 0982 Chris Lewis +49 174 244 9501 Laurent de Weck +41 79 795 7364 Attachment Media Release Hyrimoz Launch Version FINAL

Drug ApprovalBiosimilarPatent ExpirationImmunotherapy

29 Nov 2022

·www.prnewswire.com

Adalimumab, Infliximab and Etanercept Biosimilars Global Market to Reach $18.61 Billion by 2026 at a 40.6% CAGR

DUBLIN, Nov. 29, 2022 /PRNewswire/ -- The "Adalimumab, Infliximab and Etanercept Biosimilars Global Market Report 2022: By Product, By Application, By Distribution" report has been added to ResearchAndMarkets.com's offering. The global adalimumab, infliximab and etanercept biosimilars market is expected to grow from $3.10 billion in 2021 to $4.76 billion in 2022 at a compound annual growth rate (CAGR) of 53.4%. The market is expected to reach $18.61 billion in 2026 at a CAGR of 40.6%. The main types of products in adalimumab, infliximab and etanercept biosimilars are adalimumab biosimilars (exemptia, mabura, hyrimoz, hadlima, abrilada, others), infliximab biosimilars (inflectra, renflexis, ixifi, avsola) and cipleumab (erelzi, eticovo). Adalimumab is a biological drug that works on the immune system to lessen inflammation. The different applications include crohn's disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, others and is distributed through various channels such as hospital pharmacies, retail pharmacies, online pharmacies. The patent expiry of branded drugs allows biosimilars to enter the market. For instance, In United States FDA approved inflectra, developed by Hospira (a Pfizer Inc company) for the treatment of various autoimmune diseases such as rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, after the patent expiry of branded drug Remicade. Similarly, Amgen's Enbrel had its patent expired in the EU and with the expiry of the patent, Benepali (a biosimilar of Enmbrel) was approved by the European Commission. Humira's patent expired and its biosimilars were made available in the market. FDA has recently (July 2020) approved Hulio, the sixth biosimilar of Humira. Therefore, the patent expiry of branded biologic drugs such as Humira, Enbrel and Remicade will drive the biosimilar market. The patent extension of Humira (adalimumab) will hamper the Humira biosimilar market. The patent extension is a strategy to compete with generic and biosimilar products after patent termination. For instance, the patents of Humira, the branded biologic drug manufactured by AbbVie, in the US and EU. AbbVie obtained Supplementary Protection Certificates (SPCs) that provided protection in Europe. AbbVie received a patent extension for Humira till 2023 in the US. In pursuit of patent extension, AbbVie also had settlements with Amgen, Samsung Bioepis, and Mylan to protect Humira sales in the United States. The patent extension of Humira is anticipated to hinder its biosimilars market growth. The brand versions of biosimilar drugs are of high costs, which are now being replaced with biosimilar versions upon their patent's expiry. The cost of branded biologic drugs almost doubled in recent years. For instance, the cost of Humira, the top-selling drug, increased to more than $72,000 in 2020. The shift to low-cost biosimilar drugs is mainly because there are no clinically relevant differences in safety and efficacy between the biosimilars and originator biologics. The Danish health care system switched almost entirely to adalimumab biosimilars after the patent on the original adalimumab product, Humira, expired in October 2018. The switch to biosimilars led to an 82% decrease in costs for the medication. Scope Markets Covered: 1) By Product: Adalimumab Biosimilars (Exemptia, Mabura, Hyrimoz, Hadlima, Abrilada, Others); Infliximab Biosimilars (Inflectra, Renflexis, Ixifi, Avsola); Cipleumab (Erelzi, Eticovo) 2) By Application: Crohn'S Disease; Psoriatic Arthritis; Rheumatoid Arthritis; Ulcerative Colitis; Ankylosing Spondylitis; Plaque Psoriasis; Others 3) By Distribution Channel: Hospital Pharmacies; Retail Pharmacies; Online Pharmacies Key Topics Covered: 1. Executive Summary 2. Adalimumab, Infliximab and Etanercept Biosimilars Market Characteristics 3. Adalimumab, Infliximab and Etanercept Biosimilars Market Trends And Strategies 4. Impact Of COVID-19 On Adalimumab, Infliximab and Etanercept Biosimilars 5. Adalimumab, Infliximab and Etanercept Biosimilars Market Size And Growth 6. Adalimumab, Infliximab and Etanercept Biosimilars Market Segmentation 7. Adalimumab, Infliximab and Etanercept Biosimilars Market Regional And Country Analysis 8. Asia-Pacific Adalimumab, Infliximab and Etanercept Biosimilars Market 9. China Adalimumab, Infliximab and Etanercept Biosimilars Market 10. India Adalimumab, Infliximab and Etanercept Biosimilars Market 11. Japan Adalimumab, Infliximab and Etanercept Biosimilars Market 12. Australia Adalimumab, Infliximab and Etanercept Biosimilars Market 13. Indonesia Adalimumab, Infliximab and Etanercept Biosimilars Market 14. South Korea Adalimumab, Infliximab and Etanercept Biosimilars Market 15. Western Europe Adalimumab, Infliximab and Etanercept Biosimilars Market 16. UK Adalimumab, Infliximab and Etanercept Biosimilars Market 17. Germany Adalimumab, Infliximab and Etanercept Biosimilars Market 18. France Adalimumab, Infliximab and Etanercept Biosimilars Market 19. Eastern Europe Adalimumab, Infliximab and Etanercept Biosimilars Market 20. Russia Adalimumab, Infliximab and Etanercept Biosimilars Market 21. North America Adalimumab, Infliximab and Etanercept Biosimilars Market 22. USA Adalimumab, Infliximab and Etanercept Biosimilars Market 23. South America Adalimumab, Infliximab and Etanercept Biosimilars Market 24. Brazil Adalimumab, Infliximab and Etanercept Biosimilars Market 25. Middle East Adalimumab, Infliximab and Etanercept Biosimilars Market 26. Africa Adalimumab, Infliximab and Etanercept Biosimilars Market 27. Adalimumab, Infliximab and Etanercept Biosimilars Market Competitive Landscape And Company Profiles 28. Adalimumab, Infliximab and Etanercept Biosimilars Pipeline Analysis 29. Key Mergers And Acquisitions In The Adalimumab, Infliximab and Etanercept Biosimilars Market 30. Adalimumab, Infliximab and Etanercept Biosimilars Market Future Outlook and Potential Analysis 31. Appendix Companies Mentioned Zydus Cadila Sandoz (Novartis) Samsung Bioepis Abbvie Amgen Boehringer Ingelheim Pfizer Celltrion Mylan Hetero Drugs Ltd. Glenmark pharmaceuticals Cipla Ltd. Emcure Pharmaceuticals Ltd. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Drug ApprovalPatent ExpirationBiosimilar

100 Deals associated with Etanercept-SZZS(Sandoz Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Etanercept-SZZS(Sandoz Inc.)	L04AB01	DB00005

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic large plaque psoriasis	European Union	Sandoz GmbH	23 Jun 2017
Chronic large plaque psoriasis	Iceland	Sandoz GmbH	23 Jun 2017
Chronic large plaque psoriasis	Liechtenstein	Sandoz GmbH	23 Jun 2017
Chronic large plaque psoriasis	Norway	Sandoz GmbH	23 Jun 2017
Enthesitis-Related Arthritis	European Union	Sandoz GmbH	23 Jun 2017
Enthesitis-Related Arthritis	Iceland	Sandoz GmbH	23 Jun 2017
Enthesitis-Related Arthritis	Liechtenstein	Sandoz GmbH	23 Jun 2017
Enthesitis-Related Arthritis	Norway	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	European Union	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	Iceland	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	Liechtenstein	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	Norway	Sandoz GmbH	23 Jun 2017
Non-radiographic axial spondyloarthritis	European Union	Sandoz GmbH	23 Jun 2017
Non-radiographic axial spondyloarthritis	Iceland	Sandoz GmbH	23 Jun 2017
Non-radiographic axial spondyloarthritis	Liechtenstein	Sandoz GmbH	23 Jun 2017
Non-radiographic axial spondyloarthritis	Norway	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	European Union	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	Iceland	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	Liechtenstein	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	Norway	Sandoz GmbH	23 Jun 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2024	Not Applicable	Rheumatoid Arthritis	-	GP2015	yzvtoprjfs(zwhdrujqgi): aHR = 0.37 (95% CI, 0.17 - 0.8), P-Value = <0.05	-	05 Jun 2024
				anti-TNF
COMPACT (EULAR2023)	Not Applicable	Arthritis, Psoriatic \| Rheumatoid Arthritis \| Axial Spondyloarthritis	-	GP2015	ndgghyciat(oijwyyejcy) = mormoguyig pjlpwglybd (ajeqzuksao )	Positive	31 May 2023
NCT02638259 (EQUIRA, Pubmed \| RMD Open) Manual	Phase 3	Rheumatoid Arthritis	376	GP2015	pnyocinpyy(ciqplpafxs): difference = -0.07 (95% CI, -0.26 to 0.12)	Similar	14 Nov 2018
				etanercept
NCT01891864 (EGALITY, Pubmed \| Br J Dermatol) Manual	Phase 3	Plaque psoriasis	531	GP2015	gfcpsldfll(oiwkxwesyi): difference = -2.3 (95% CI, 9.85 - 5.30)	Similar	01 Apr 2017
				Enbrel
NCT01891864 (EGALITY, CTgov)	Phase 3	Chronic large plaque psoriasis	531	GP2015 Etanercept (GP2015 Etanercept)	jnxnngefxz = jaimticuws mdqohzkoej (uiykopdnpk, mujvvdskyu - kfnujxsxwn) View more	-	27 Mar 2017
				Enbrel (Enbrel ® Etanercept)	jnxnngefxz = lkllczcwps mdqohzkoej (uiykopdnpk, nrztffnzhe - eccqcufntz) View more

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