A Randomised, Two-period, Two-sequence, Single-dose and Cross-over Study in Healthy Subjects to Demonstrate Pharmacokinetic Equivalence of Altebrel (Produced by Aryogen Pharmed) and Enbrel® (the Reference Drug, Produced by Amgen Company)

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and tolerability of Altebrel, in a crossover fashion in healthy male volunteers after administration of a single dose (25 mg) of etanercept.
The primary objective of this study is to demonstrate that the PK of Altebrel is similar to its originator, Enbrel®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.
The secondary objectives of the study are:
To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.

Start Date04 Dec 2016

Sponsor / Collaborator

Aryogen Pharmed

EUCTR2012-002009-23-DE / 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 Date22 Feb 2016

Sponsor / Collaborator

Hexal AG

NCT02656082 / CompletedPhase 2

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]

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

OBJECTIVESTo evaluate the pricing of etanercept (ETN) reference and biosimilar drugs in a changing competitive to monopolized market.METHODSWe 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.RESULTSBetween 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.CONCLUSIONSThis 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: Kalsekar, Sameer ; Anjaneya, Pradeep ; Sagi, Sreedhar ; Kottke, Andrea ; Cohen, Hillel P

BACKGROUNDBiosimilars 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.METHODSPost-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).RESULTSThe 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.CONCLUSIONSThis 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·TherapiesQ4 · MEDICINE

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

Q4 · MEDICINE

Article

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

OBJECTIVESince 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.METHODSThe 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.RESULTSThe 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.CONCLUSIONSThis 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.)

06 Aug 2024

·pipelinereview.com

Lupin Launches Rymti® Biosimilar Etanercept in Canada

MUMBAI, India | BOUCHERVILLE, Canada I May 03, 2024 I Global pharma major Lupin Limited (Lupin) today announced the launch of Rymti®, Lupin’s first biosimilar in Canada, through its partner Sandoz Canada (Sandoz). Rymti® is indicated for the treatment of moderate to severe active rheumatoid arthritis, juvenile idiopathic arthritis, active and progressive psoriatic arthritis, severe axial spondyloarthritis, moderate to severe plaque psoriasis and chronic severe plaque psoriasis in children and adolescents. Rymti® is approved for all therapeutic indications of the reference product Enbrel®. Etanercept as an established therapy option Lupin’s Etanercept was first approved for the treatment of rheumatoid arthritis by PMDA in 2019, EMA in 2020, Health Canada in 2022, and since then has offered an effective treatment option for several chronic inflammatory diseases. Patient friendly application by means of pre-filled pen Rymti® is available as a solution for injection in a pre-filled pen and pre-filled syringe. Data show a high patient acceptance of the easy-to-handle pre-filled pen. Patients favored this latex-free device for self-injection, which can lead to improvement in compliance. Cost-effective treatment with Rymti® Rymti®, with an equivalent efficacy and safety to reference product Enbrel®, is an attractive cost-effective treatment alternative that can contribute to sustainable healthcare and treatment options. The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), in August 2022, for all indications of the reference product Enbrel. “We are delighted to announce the launch of Rymti®, Lupin’s first biosimilar in Canada through our partner Sandoz,” said Vinita Gupta, Chief Executive Officer, Lupin . “With this important milestone, we continue to advance healthcare accessibility and affordability for patients in Canada.” “Etanercept is used globally in the fight against a range of severe autoimmune disorders. We are happy to bring etanercept to the patients in Canada. We have diligently worked to build our portfolio to include etanercept ensuring patients have access to effective and affordable equivalent. This launch demonstrates our commitment to fostering healthcare solutions that truly make a difference,” said Dr. Cyrus Karkaria, President Biotechnology, Lupin. Michel Robidoux, President and General Manager, Sandoz Canada said, “The launch of Rymti® is a key milestone for Sandoz Canada. Thanks to our exclusive partnership with Lupin, we’re adding another etanercept option on the Canadian market, increasing access for patients.” About Etanercept Etanercept is an injectable biologic medicine that inhibits the biological activity of Tumor Necrosis Factor (TNF). TNF is a key cytokine involved in the pro-inflammatory cascade in many chronic, immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. Etanercept as a soluble TNF receptor fusion protein specifically binds to TNF and blocks its activity, thereby reducing inflammation and disease symptoms. About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector. Please visit www.lupin.com for more information. SOURCE: Lupin

Drug ApprovalBiosimilar

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

02 Feb 2024

·www.biospace.com

CMS Sends Initial Medicare Drug Price Proposals to Companies

Pictured: Sign at the Department of Health and Human Services' office in Washington, DC/iStock, JHVEPhoto The Department of Health and Human Services announced Thursday that it sent initial proposals to pharma companies, kicking off a months-long process to settle on a maximum fair price for the 10 drugs selected for negotiations under the Inflation Reduction Act. The Centers for Medicare and Medicaid Services is conducting these negotiations and participating drugmakers have 30 days to either signify that they agree with the proposed pricing or submit a counteroffer. At a JPM Week event last month, life sciences lobbying group Incubate predicted that all 10 companies would challenge CMS’s initial offer, particularly as the Biden administration is expected to make “draconian” price cuts amid the political pressure of the presidential election year. Analysts agreed this week, telling Reuters that they expect that CMS would propose steep discounts in their initial offer, ranging from a statutory price cut minimum of 25% and reaching as high as 60%. Negotiations will take place through the spring and summer and are scheduled to end on Aug. 1, according to a CMS fact sheet. The agency has until Sept. 1 to publish the final negotiated maximum fair prices for the 10 selected drugs, which will then take effect in 2026. “Allowing Medicare to negotiate drug prices is just one tool we’re using to lower prices thanks to the President’s lower cost prescription drug law,” HHS Secretary Xavier Becerra said in a statement. “From capping insulin at $35 per month, to making drug companies pay a rebate for raising their prices faster than inflation, to capping out of pocket costs in Part D, we are delivering on that day-one promise.” However, the Pharmaceutical Research and Manufacturers of America (PhRMA) on Thursday said in a statement CMS’s initial price-setting “offer” to companies was an effort to “win political points on the campaign trail.” PhRMA also criticized the negotiations process for its lack of transparency and “operating behind closed doors to set medicine prices without disclosing for months how they arrived at the price or how much patient and provider input was used.” The Inflation Reduction Act (IRA) was signed into law in August 2022, as part of the Biden administration’s effort to generate some $25 billion in drug cost savings annually by 2031. To help achieve this goal, the IRA allows CMS to negotiate prices for some of the most widely prescribed medicines. The first 10 drugs that would be impacted by these negotiations were named in August 2023 and include BMS’s Eliquis (apixaban), Novartis’ Entresto (sacubitril/valsartan), Amgen’s Enbrel (etanercept), Lilly’s Jardiance (empagliflozin), AstraZeneca’s Farxiga (dapagliflozin), Merck’s Januvia (sitagliptin), Novo Nordisk’s insulin products Fiasp and Novolog and J&J’s Xarelto (rivaroxaban), Imbruvica (ibrutinib) and Stelara (ustekinumab). HHS on Thursday also released data from several reports showing the disparity in drug prices between the U.S. and other countries in the Organization for Economic Cooperation and Development (OECD). The findings show that in 2022 prices across all drugs in the U.S. were nearly three times as high as prices in 33 OECD countries, with American consumers paying $2.78 per dollar paid in those other countries for medicines. The gap is even larger for insulin, which was nearly 10 times more expensive in the U.S. than in the 33 countries. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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

External Link

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

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic large plaque psoriasis	EU	Sandoz GmbH	23 Jun 2017
Chronic large plaque psoriasis	LI	Sandoz GmbH	23 Jun 2017
Chronic large plaque psoriasis	IS	Sandoz GmbH	23 Jun 2017
Chronic large plaque psoriasis	NO	Sandoz GmbH	23 Jun 2017
Enthesitis-Related Arthritis	LI	Sandoz GmbH	23 Jun 2017
Enthesitis-Related Arthritis	NO	Sandoz GmbH	23 Jun 2017
Enthesitis-Related Arthritis	EU	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	IS	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	EU	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	NO	Sandoz GmbH	23 Jun 2017
Juvenile Idiopathic Arthritis	LI	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	LI	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	IS	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	EU	Sandoz GmbH	23 Jun 2017
Oligoarticular Arthritis	NO	Sandoz GmbH	23 Jun 2017
Ankylosing Spondylitis	US	Sandoz, Inc.	30 Aug 2016
Arthritis, Psoriatic	US	Sandoz, Inc.	30 Aug 2016
Plaque psoriasis	US	Sandoz, Inc.	30 Aug 2016
Polyarticular Juvenile Idiopathic Arthritis	US	Sandoz, Inc.	30 Aug 2016
Rheumatoid Arthritis	US	Sandoz, Inc.	30 Aug 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	RS	Sandoz AG	21 Feb 2015
Rheumatoid Arthritis	Phase 2	MX	Sandoz AG	21 Feb 2015
Rheumatoid Arthritis	Phase 2	RU	Sandoz AG	21 Feb 2015
Chronic large plaque psoriasis	Phase 2	RU	Sandoz AG	01 Jun 2013
Chronic large plaque psoriasis	Phase 2	UA	Sandoz AG	01 Jun 2013
Chronic large plaque psoriasis	Phase 2	ZA	Sandoz AG	01 Jun 2013
Chronic large plaque psoriasis	Phase 2	RU	Hexal AG	01 Jun 2013
Chronic large plaque psoriasis	Phase 2	UA	Hexal AG	01 Jun 2013
Chronic large plaque psoriasis	Phase 2	ZA	Hexal AG	01 Jun 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2024	Not Applicable	Rheumatoid Arthritis	-	GP2015	nzhcspviao(fcsjuoytlu): 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	(ggnghvnahd) = kasgrccmoc macmxrzqqx (jbrfkgfikq )	Positive	31 May 2023
EULAR2020	Not Applicable	Arthritis	477	Etanercept originator	(dkwnenymxb) = iztydywsrh kcfkcenkrh (qrwkcvmclw ) View more	-	03 Jun 2020
				SB4	(dkwnenymxb) = urdueajwir kcfkcenkrh (qrwkcvmclw ) View more
NCT02638259 (EQUIRA, Pubmed \| RMD Open) Manual	Phase 3	Rheumatoid Arthritis	376	GP2015	(iomqpiolva): difference = -0.07 (95% CI, -0.26 to 0.12)	Similar	14 Nov 2018
				etanercept
equira study (EULAR2018)	Phase 3	Rheumatoid Arthritis	-	GP2015	(okmyotvksx) = oshsuhoaar wjpafnibab (qtuifiezqv ) View more	-	13 Jun 2018
				ETN	(okmyotvksx) = jpepjoqpqt wjpafnibab (qtuifiezqv ) View more
NCT01891864 (EGALITY, Pubmed \| Br J Dermatol) Manual	Phase 3	Plaque psoriasis	531	GP2015	(mghqjisxjz): 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)	xzttasjfxo(ddzswkzrku) = uiahqmcrxq joqiqujdil (kjnjfsnjah, uualsevdjl - ahxpsastzc) View more	-	27 Mar 2017
				Enbrel (Enbrel ® Etanercept)	xzttasjfxo(ddzswkzrku) = plfqftdejt joqiqujdil (kjnjfsnjah, thuwfpgeex - dgghczwzki) View more

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