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.)

15 Apr 2025

·www.echemi.com

Sandoz Challenges Amgen’s $3.3B Arthritis Drug Monopoly in U.S. Antitrust Lawsuit

Swiss pharmaceutical company Sandoz has initiated a legal battle against U.S. biotech giant Amgen, accusing it of unlawfully maintaining a monopoly over the arthritis medication Enbrel (etanercept). Filed in a federal court in Norfolk, Virginia, the lawsuit alleges that Amgen has employed a “thicket of patents” to block competition from biosimilars, including Sandoz’s Erelzi, effectively extending its market dominance through 2029. Despite receiving FDA approval for Erelzi in 2016, Sandoz claims it has been unable to enter the U.S. market due to Amgen’s patent strategies. The company argues that this has resulted in billions of dollars in profits for Amgen while denying patients access to more affordable alternatives. In 2024 alone, Enbrel generated $3.3 billion in U.S. revenue. Sandoz is seeking an injunction to lift the patent barriers and is also requesting financial damages. Amgen has yet to respond to the lawsuit.

Patent Infringement

14 Apr 2025

·www.globenewswire.com

[Corrected] Sandoz files antitrust litigation against Amgen regarding patient access to etanercept biosimilar in the US

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules – corrected: reference to date of product launch in Europe removed; link to “Important Safety Information” updated Company aims to accelerate access to much-needed biosimilar to reference medicine Enbrel®* for US patients with disabling inflammatory diseasesDespite FDA approval nearly a decade ago, etanercept biosimilar continues to be blockedSandoz seeking damages in addition to clearing path for launch Basel, April 14, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel® (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. Etanercept is a biologic medicine used to treat a range of disabling inflammatory diseases. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®+ (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. In 2024, Enbrel® generated USD 3.3 billion in revenue in the US[1]. Sandoz received US FDA approval for Erelzi® in 2016. Today, Amgen is continuing to block entry of this important treatment option for approximately 7.5 million Americans living with chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis[2-6], many of whom could benefit from the cost savings and expanded access resulting from the introduction of high-quality, more-affordable biosimilar options. Sandoz is seeking an injunction to prevent Amgen from using certain patent rights to block biosimilar competition and allow Sandoz to launch Erelzi® as soon as possible. The company is also seeking damages, which could be tripled under applicable laws. The lawsuit was filed in the US District Court for the Eastern District of Virginia. *Enbrel® is a registered trademark of Amgen, Inc.+Erelzi® is a registered trademark of Sandoz Inc. About Erelzi® (etanercept-szzs)Erelzi® is the Sandoz biosimilar of the reference medicine Enbrel®. Erelzi® has been studied in a global development program, which included a comprehensive comparison of Erelzi® and Enbrel® at the analytical, preclinical, and clinical levels. The program included preclinical studies, pharmacokinetic (PK) studies, and the Phase III confirmatory safety and efficacy EGALITY study. Erelzi® is approved by the US FDA for the following indications: adult rheumatoid arthritis (RA), ankylosing spondylitis (AS), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and moderate to severe plaque psoriasis (PsO). IMPORTANT SAFETY INFORMATIONPlease see full Prescribing Information for Erelzi® here. DISCLAIMERThis 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. 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. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 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 2024, Sandoz recorded net sales of USD 10.4 billion. REFERENCES 1. Statista. Revenue of Amgen’s Enbrel by Region from 2011-2014. Available at: Revenue Enbrel worldwide by region 2024 | Statista [Last accessed: March 2025]2. Xu Y, Wu Q. Prevalence Trend and Disparities in Rheumatoid Arthritis among US Adults, 2005-2018. J Clin Med. 2021;10(15):3289. Available at: https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC8348893/ [Last accessed: March 2025]3. Johns Hopkins Arthritis Center. Ankylosing Spondylitis. Available at: https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/ [Last accessed: March 2025]4. About Juvenile Idiopathic Arthritis. Available at: https://www.arthritis.org/getmedia/6398ed64-029b-4629-82e7-bf91fa61d8f5/Juvenile-Idiopathic-Arthritis-JIA-FactSheet-101122.pdf [Last accessed: March 2025]5. National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/psoriasis-statistics [Last accessed: March 2025]6. Weiss PF. Polyarticular juvenile idiopathic arthritis: Clinical manifestations, diagnosis, and complications. Available at: https://www-uptodate-com.libproxy1.nus.edu.sg/contents/polyarticular-juvenile-idiopathic-arthritis-clinical-manifestations-diagnosis-and-complications [Last accessed: March 2025] CONTACTS Global Media Relations contactsInvestor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comAlex Kalomparis+41 792 790285Craig Marks+44 781 8 94 2383Joerg E. Allgaeuer+49 171 838 4838Rupreet Sandhu+41 791 05472US Media Relations contacts Media.Info@sandoz.com Vicki Crafton+1 201 213 6338 Attachment Media release_Etanercept Amgen Antitrust Litigation_corrected

Drug ApprovalPhase 3BiosimilarPatent InfringementClinical Result

14 Apr 2025

·endpts.com

Sandoz sues Amgen over nine-year launch delay for Enbrel biosimilar

Amgen has enjoyed a monopoly on its blockbuster inflammatory disease drug Enbrel for almost 27 years now. After accumulating $86 billion in global sales, the company is still trying to keep biosimilars off the market, Sandoz alleged in a new lawsuit against Amgen. Sandoz’s lawsuit in Virginia district court seeks to immediately launch its biosimilar, Erelzi — which the FDA approved in 2016 — and alleges that Amgen will otherwise use a fortress of patents to keep biosimilars at bay until 2029. Sandoz claims Amgen since 2020 has unlawfully engaged in “cross-market bundling,” which allegedly involves ensuring a certain level of Enbrel rebates in exchange for giving Amgen drugs preferred placement on insurers’ and PBMs’ lists of covered drugs. Amgen declined to comment on pending litigation. Acquiring certain patents from Roche relating to TNFR fusion proteins, including Enbrel, “allowed Amgen to illegally prolong its U.S. Enbrel monopoly for at least an additional decade,” Sandoz alleges in the suit filed Friday. “While Amgen has been able to unlawfully hold back biosimilar competitors, like Sandoz, in the U.S. market, Sandoz launched its etanercept biosimilar in Europe more than eight years ago.” Enbrel, which pulled in more than $3 billion last year for Amgen, has seen steady price increases over the years and is approved to treat a range of disabling inflammatory diseases like rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Novartis, which was the parent company of Sandoz before being spun off in 2023, previously lost its attempt to have the US Supreme Court review the issue in a separate case. Sandoz claims in the latest suit that it would have earned about $1 billion from its biosimilar Erelzi over the last four years, if it had been able to launch. At the state level, Colorado has already sought to cap the price of Enbrel, which Amgen called “unconstitutional” in its suit over the price intervention last June.

Patent InfringementDrug ApprovalBiosimilar

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	vvoqqtsahf(djdavolxup): 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	cwaimiivji(lruuggmfyz) = duuputkiri iaaebrybzl (pmwetidpqj )	Positive	31 May 2023
NCT02638259 (EQUIRA, Pubmed \| RMD Open) Manual	Phase 3	Rheumatoid Arthritis	376	GP2015	yylkjjmvzg(sijxyasjdi): 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	bvijxyivvh(lappyrycnf): 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)	ncgwxydjnv = cjljptknkx poxdaitizz (tdometmpxl, klmibasbax - cnreznycdm) View more	-	27 Mar 2017
				Enbrel (Enbrel ® Etanercept)	ncgwxydjnv = xjxtxexclc poxdaitizz (tdometmpxl, xpflckwcws - znrfawtkyx) View more

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