TNFR1 inhibitors(Tumor necrosis factor receptor superfamily member 1A inhibitors), TNFR2 antagonists(Tumor necrosis factor receptor superfamily member 1B antagonists), Immunostimulants

Therapeutic Areas

Neoplasms

Active Indication

Sarcoma

Inactive Indication-

Originator Organization

Genentech, Inc.

Active Organization

Belpharma Sa

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (12 Apr 1999),

Sarcoma

Regulation-

Structure/Sequence

Sequence Code 21780

Source: *****

Clinical Trials associated with Tasonermin

NCT01490047

/ WithdrawnPhase 1IIT

Phase I Trial of Intravenous Recombinant Human TNF-α and Liposomal Doxorubicin in Patients With Advanced Solid Tumors or Lymphomas

Assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of recombinant human tumor necrosis factor-α (rhTNF-α) when given as a single dose intravenously and in combination with liposomal doxorubicin in human subjects

Start Date01 Jan 2013

Sponsor / Collaborator

Ludwig Institute for Cancer Research Ltd.

[+1]

NCT02886689

/ CompletedNot ApplicableIIT

C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France

C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities.
Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years.
A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.

Start Date01 Jan 2007

Sponsor / Collaborator

Centre Hospitalier Regional de Nancy

NCT00181025

/ Unknown statusPhase 2IIT

Isolated Pelvic and Limb Perfusion With 1mg TNFa in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle

This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs' girdle.

Start Date01 May 2004

Sponsor / Collaborator

Institut Gustave Roussy EURL

100 Clinical Results associated with Tasonermin

100 Translational Medicine associated with Tasonermin

100 Patents (Medical) associated with Tasonermin

387

Literatures (Medical) associated with Tasonermin

01 Apr 2025·Seminars in Arthritis and Rheumatism

Evolution of bone lesions in adults with chronic nonbacterial osteitis (CNO): A long-term follow-up study

Article

Author: Navas-Cañete, Ana ; Winter, E M ; Leerling, Anne T ; Dekkers, O M ; Weizenbach, Christophe C J

OBJECTIVESChronic nonbacterial osteitis (CNO) is a rare disease characterised by sterile bone inflammation. Little is known about the evolution of bone lesions, especially for the adult variant of the disease (adult CNO). We therefore aimed to characterize the radiologic course of adult CNO.METHODSWe conducted a cohort study among confirmed adults with CNO, treated at the Dutch national CNO referral centre between 1992 and 2023. Imaging reports from the first-performed radiological scan (baseline) to the last available scan (end of follow-up) were systematically reviewed for lesion location and radiologic features (sclerosis, hyperostosis, erosions, ankylosis). Incidence rates (IRs) for new lesions, progression, and regression of existing lesions were estimated using the Poisson method. Kaplan-Meier curves were used to visualize cumulative incidence, and Poisson regression models assessed associations between patient characteristics and the outcomes.RESULTSThe study included 182 adult CNO patients with a mean follow-up of 6.1 ± 5.2 years, treated with nonsteroidal anti-inflammatory drugs or cyclooxygenase-inhibitors and/or intravenous bisphosphonates or tumour necrosis factor alpha inhibitors. The most common pattern was sole involvement of the anterior chest wall (84 %). IRs per 100 person-years were 4 (95 % CI 3-5) (new lesions), 7 (6-9) (progression), and 1 (0.3.-1) (regression). Among patients with anterior chest wall involvement only (n = 147), one person developed a lesion outside this area (IR 0.3 (0.06-1)). At 2 years, cumulative incidence of new lesion development and progression were 2 % (0-5) and 7 % (3-10), increasing to 11 % (5-17) and 29 % (20-36) at 5 years, and 36 % (23-48) and 56 % (43-64) at 10 years. No associations were found between clinical characteristics at baseline and these outcomes.CONCLUSIONSThe development of new bone lesions in treated adult CNO patients is typically confined to previously affected regions, primarily the anterior chest wall. Progression of structural changes occurs in the majority of patients after longer follow-up. These findings can be used for prognostic counselling, and suggest that routine whole-body imaging may not be necessary for most patients during follow-up.

01 Mar 2025·Clinical Gastroenterology and Hepatology

Outcomes of Long-term Tumor Necrosis Factor Alpha Inhibitor Therapy Beyond 10 Years in Inflammatory Bowel Disease

Article

Author: Omede, Mmeyeneabasi ; Ananthakrishnan, Ashwin N ; Dicken, Quinten ; Ananthakrishnan, Ashwin N.

01 Feb 2025·BMJ Case Reports

Atypical cutaneous leishmaniasis in a patient under tumour necrosis factor alpha inhibitor for psoriasis

Article

Author: Teixeira, Diogo ; Malheiro, Luis ; Magalhaes, Cesar ; Coelho, Andre

Tumor necrosis factor (TNF) inhibitors are associated with a higher risk of infection. Cases of cutaneous leishmaniasis have been rarely reported in this population, mostly with those taking adalimumab and infliximab.A man in his 60s with chronic plaque psoriasis developed a cutaneous lesion on his leg after 2 years of adalimumab therapy. It was initially misdiagnosed and unsuccessfully treated as a bacterial ulcer, but a skin biopsy later confirmedLeishmania donovanicomplex infection. Adalimumab was discontinued, and the patient was treated with intravenous liposomal amphotericin B, leading to the resolution of the ulcers. His psoriasis worsened post-treatment but was managed with risankizumab, and 2 years later, no evidence of leishmaniasis relapse was noted.This case highlights the importance of vigilance for leishmaniasis in patients taking TNF inhibitors, especially in endemic regions, as diagnosis can be challenging. Although there is no consensus on managing leishmaniasis in this population, treatment often involves discontinuing TNF inhibitors and using systemic antileishmanial drugs.

News (Medical) associated with Tasonermin

15 Jul 2024

·www.prnewswire.com

SKYRIZI's Approval For Ulcerative Colitis Treatment Expands AbbVie's Portfolio Across Immune-mediated Inflammatory Diseases | DelveInsight

AbbVie's rapidly expanding Humira successor, SKYRIZI, is already achieving impressive sales growth. This IL-23 inhibitor is set to capture an even greater portion of Humira's diminishing market share with its crucial expansion into treating ulcerative colitis. LAS VEGAS, July 15, 2024 /PRNewswire/ -- Ulcerative colitis is an idiopathic inflammatory bowel disease affecting ~1.5 million patients in the US and with an unknown exact cause. It affects the colonic mucosa and is clinically characterized by diarrhea, stomach discomfort, pain, and hematochezia. The disease's extent varies, affecting either the rectum, the splenic flexure of the left side of the colon, or the whole of the rectum and bowel. As per DelveInsight analysis, the total ulcerative colitis diagnosed prevalent cases in the 7MM comprised approximately 3 million cases in 2023 and are projected to increase by 2034. Per analyst estimates, approximately 60% of cases accounted for moderate to severe cases of ulcerative colitis among the 7MM. The current treatments for ulcerative colitis depend on the severity of the disease and are broadly divided into six classes, comprising conventional therapies, Anti-TNFs, Anti-integrin agents, IL-12/IL-23 dual inhibitors, S1P-receptor modulators, and JAK inhibitors. The emergence of several mechanisms of action, like LANCL2 protein stimulators, miR-124 enhancers, tumor necrosis factor (TNF)-like ligand 1A inhibitors, toll-like receptor 9 agonists, and others will be expanding the treatment landscape of ulcerative colitis. There have been significant advancements in treating ulcerative colitis over the years. However, safety remains a major challenge. The lack of a safer and curative treatment option severely impacts patients' quality of life and daily activities. While current treatments are effective for some patients with ulcerative colitis, others need multiple lines of therapy, indicating a need for alternative treatments to achieve disease control. Several major pharmaceutical companies are collaborating to develop new solutions to address these issues. Learn more about the FDA-approved ulcerative colitis drugs @ Drugs for Ulcerative Colitis Treatment A few FDA-approved drugs for ulcerative colitis treatment include SIMPONI (Janssen Pharmaceuticals), ENTYVIO (Takeda Pharmaceuticals), OMVOH (Eli Lilly) VELSIPITY (Arena Pharmaceuticals/Pfizer), and SKYRIZI (AbbVie). SIMPONI is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein associated with inflammation and tissue damage in chronic inflammatory diseases. It is the first subcutaneous anti-TNF-alpha treatment administered every four weeks as maintenance therapy for ulcerative colitis. Approved for treating moderately to severely active ulcerative colitis in adults, SIMPONI is also being evaluated in ongoing trials for pediatric patients with the same condition. Vedolizumab is a humanized monoclonal antibody that targets and inhibits the alpha 4 beta 7 integrin, preventing it from binding to the intestinal mucosal addressing cell adhesion molecule 1 (MAdCAM-1). This integrin is found in a subset of circulating white blood cells that play a role in the inflammatory processes of ulcerative colitis and Crohn's disease. By blocking the alpha 4 beta 7 integrin, vedolizumab may reduce the infiltration of these white blood cells into gut tissues. It is currently approved as an IV and SC formulation for the treatment of moderately to severely active ulcerative colitis in adults who have not responded to, lost response to, or were intolerant to conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. VELSIPITY (Etrasimod) is an innovative, once-daily oral medication that acts as a highly selective modulator of the sphingosine 1-phosphate (S1P) receptor. Discovered by Arena, it is designed for optimized interaction with S1P receptors 1, 4, and 5, potentially offering better efficacy and safety. Etrasimod targets specific immune cells both systemically and locally and has the potential to treat various immune-mediated inflammatory diseases, such as Crohn's disease and ulcerative colitis. It is currently approved by the FDA and EMA for adults with moderately to severely active ulcerative colitis who have not responded adequately, lost response, or were intolerant to conventional or advanced therapies. Recently, on 18 June 2024, the FDA approved SKYRIZI for treating adult patients with moderately to severely active ulcerative colitis. This approval extends the drug's reach to approximately 1 million US patients and makes SKYRIZI the first IL-23 inhibitor approved for both UC and Crohn's disease, the two types of inflammatory bowel disease (IBD). After a 12-week induction period, patients can self-administer the medication at home using an on-body injector device, which AbbVie's press release describes as "designed with patients in mind." The device attaches to the body and delivers the medication in about five minutes. Since its approval for Crohn's in 2022, Skyrizi has emerged as a strong competitor to Johnson & Johnson's blockbuster drug STELARA in the IBD market. The AbbVie medication has captured a "significant share" of STELARA's sales. To know more about ulcerative colitis treatment options, visit @ New Treatment for Ulcerative Colitis The ulcerative colitis market is crowded with so many companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, and others are running clinical trials to improve the treatment space. The ulcerative colitis pipeline possesses potential drugs in mid-stage developments to be launched shortly. Some of the promising drugs in the pipeline include TREMFYA, ABX464, BT-11 (Omilancor), PRA023, Remestemcel-L, SHR0302 (Ivarmacitinib), and others that hold the potential to create a significant positive shift in the ulcerative colitis market size. Discover which therapies are expected to grab major ulcerative colitis market share @ Ulcerative Colitis Market Report TREMFYA (guselkumab) is a human monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, created by Janssen. IL-23 plays a crucial role in the pathogenesis of inflammatory diseases like ulcerative colitis and Crohn's disease. TREMFYA, an IL-23 inhibitor, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, produced in a mammalian cell line using recombinant DNA technology. It specifically binds to the p19 subunit of IL-23 and blocks its interaction with the IL-23 receptor. In May 2024, Johnson & Johnson released the initial data from the Phase III QUASAR maintenance study in ulcerative colitis, which achieved its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission. Based on these findings, the company has submitted a supplemental Biologics License Application (sBLA) to the FDA. SHR0302, developed by Reistone Biopharma, is an innovative and potent oral JAK1 inhibitor aimed at treating inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Due to its selectivity for JAK1, it may offer a safer and more effective alternative to pan-JAK inhibitors. Ongoing long-term clinical studies are investigating whether JAK1 selectivity can minimize hematological side effects associated with JAK2 inhibition, aiming to confirm a favorable risk-benefit profile (Reistone Biopharma, 2021a). SHR0302 is currently being tested in a Phase III clinical trial (NCT05181137) for the treatment of moderate to severe ulcerative colitis in adults. Discover more about drugs for ulcerative colitis in development @ Ulcerative Colitis Clinical Trials The anticipated launch of these emerging therapies for ulcerative colitis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the ulcerative colitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for ulcerative colitis is expected to grow from USD 8.4 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the ulcerative colitis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Ulcerative Colitis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the ulcerative colitis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The ulcerative colitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Ulcerative Colitis Age-specific Cases of Ulcerative Colitis Severity-specific Cases of Ulcerative Colitis Total Treated Patients of Ulcerative Colitis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM ulcerative colitis market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this ulcerative colitis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the ulcerative colitis market. Also, stay abreast of the mitigating factors to improve your market position in the ulcerative colitis therapeutic space. Related Reports Ulcerative Colitis Epidemiology Forecast Ulcerative Colitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted ulcerative colitis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, GlaxoSmithKline, Galapagos, Celgene, Gossamer Bio, Eisai, UCB, Suzhou Connect Biopharmaceuticals, Landos Biopharma, Seres Therapeutics, Abivax, Genentech, ParaTech A/S, I-Mab Biopharma, Sublimity Therapeutics Holdco, Reistone Biopharma, Qu Biologics, PurGenesis Technologies, Protagonist Therapeutics, Pfizer, Palobiofarma, Novartis Pharmaceuticals, Bristol-Myers Squibb, Bridge Biotherapeutics, Amgen, Allergan, Applied Molecular Transport, AbGenomics International, Protalix BioTherapeutics, LTT Bio-Pharma Co Ltd, Dongwha pharma, Seres Therapeutics, Innovation Pharmaceuticals, Holy Stone Healthcare, SLA Pharma, OSE Immunotherapeutics, Bridge Biotherapeutics, Mitsubishi Tanabe Pharma, Sterna Biologicals, Mesoblast, Oncostellae, First Wave Bio, Oppilan Pharma, NeuClone, Morphic Therapeutic, Metacrine, LG Chem, Koutif Therapeutics, Kiniksa Pharmaceuticals, Avaxia Biologics, Algernon Pharmaceuticals, Akeso Biopharma, Kaleido Biosciences, Rebiotix, Prometheus Biosciences, PNB Vesper Life Science, Pandion Therapeutics, Palatin Technologies, Theravance Biopharma, VHsquared, Seres Therapeutics, Hoffmann-La Roche, Provention Bio, Bacainn Therapeutics, Landos Biopharma, Bristol-Myers Squibb, Janssen Research & Development, GlaxoSmithKline, Assembly Biosciences, NuBiyota, Tarus Therapeutics, Servatus, Athos Therapeutics, Aclaris Therapeutics, Exeliom Biosciences SAS, Voronoi Group, Ventria Bioscience, TheraSource LLC, Synlogic Inc, Synedgen, Surrozen Inc, StemRIM Inc, Shaperon Inc, Sareum Holdings, Saniona, RhemaStem, Regentys, Progenity, Pharmaxis, Pharmabiome, PanTheryx, Oncodesign, Nyrada, Microbiotica, MAKScientific, KoBioLabs, Istesso, Intract Pharma, Innovimmune Biotherapeutics, Impetis Biosciences, Finch Therapeutics Group, Vivreon Biosciences, NuMedii, Intact Therapeutics, Giiant Pharma, among others. Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies, including Celgene, AstraZeneca, Abbvie, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, Amgen, Priothera, SLA Pharma, HAV Vaccines Ltd, Enzo Biochem Inc., VHsquared Ltd., among others. Irritable Bowel Syndrome Market Irritable Bowel Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key irritable bowel syndrome companies, including Arena Pharmaceuticals, 4D Pharma, OrphoMed, Boston Pharmaceuticals, RedHill Biopharma Limited, Takeda, Cosmo Technologies, CinRx Pharma, Rottapharm, Synthetic Biologics, Biomica, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Drug ApprovalClinical Result

08 Sep 2022

·www.sciencedaily.com

Key protein that drives rheumatoid arthritis damage

Scientists have identified a protein known as sulfatase-2 that plays a critical role in the damage caused by rheumatoid arthritis. The researchers' discovery sheds new light on the molecular processes that drive inflammation seen in rheumatoid arthritis. It could also someday lead to improved treatment of the disease, which currently has no cure. Scientists have identified a protein known as sulfatase-2 that plays a critical role in the damage caused by rheumatoid arthritis. A chronic disease in which the immune system attacks the body's own joint tissues, rheumatoid arthritis affects an estimated 1.5 million Americans. Published in the journal Cellular & Molecular Immunology, the discovery sheds new light on the molecular processes that drive inflammation seen in rheumatoid arthritis. It could also someday lead to improved treatment of the disease, which currently has no cure. "Tumor necrosis factor-alpha -- or TNF-alpha for short -- is one of the main inflammatory proteins that drive rheumatoid arthritis and is targeted by many currently available therapies," said senior author Salah-Uddin Ahmed, a professor in Washington State University's College of Pharmacy and Pharmaceutical Sciences. "However, over time patients can develop a resistance to these drugs, meaning they no longer work for them. That is why we were looking for previously undiscovered drug targets in TNF-alpha signaling, so basically proteins that it interacts with that may play a role." Though sulfatases such as sulfatase-2 have been extensively studied for their roles in different types of cancer, Ahmed said no one had looked at how they might be involved in inflammatory or autoimmune diseases such as rheumatoid arthritis. The research team first explored this idea using cells called synovial fibroblasts, which line the joints and keep them lubricated to ensure fluid movement. "In rheumatoid arthritis, these normally quiescent cells get activated by TNF-alpha and other inflammatory molecules, and they take on this aggressive character," said first author Ruby J. Siegel, a PhD graduate in the WSU College of Pharmacy and Pharmaceutical Sciences. "They are not dying when they should, and they proliferate in a way that is almost tumor-like, forming this massive synovial tissue that should not be anywhere near that size and at the same time activating proteins that destroy cartilage and bone." Using the joint-lining cells of rheumatoid arthritis patients, they removed sulfatase-2 from one group of cells before stimulating all cells with the inflammatory TNF-alpha. What they found was that cells lacking sulfatase-2 did not show the same exaggerated inflammatory response to TNF-alpha as cells that were left intact. "Looking at sulfatases for their potential role in inflammation was an educated guess, but once we did we saw a very consistent pattern of increased sulfatase-2 expression throughout different tissues and samples we studied," Ahmed said. "This tells us that TNF-alpha relies on sulfatase-2 to drive inflammation, because as soon as we removed sulfatase-2 the inflammatory effects of TNF-alpha were markedly reduced." Resulting from a series of experiments spanning four years, the researchers' findings open the door to future animal studies to test the effectiveness of inhibiting sulfatase-2 to ease rheumatoid arthritis symptoms. This could someday lead to the development of new combination therapies that along with other inflammatory proteins would also target sulfatase-2 to prevent bone loss, cartilage damage and deformed joints. Such therapies could help address the shortcomings of currently available rheumatoid arthritis drugs, many of which come with significant side effects. "These drugs shut off TNF-alpha in your whole body, but it does have important immune functions," Siegel said, adding that patients who take these types of drugs are more susceptible to infection and have an increased risk of developing cancer with long-term use. She also noted that TNF-alpha inhibitors are not effective in all people and are not recommended for patients with certain other health conditions. Funding support for the study came from the National Institutes of Health and the Rheumatology Research Foundation.

07 Oct 2015

·www.biospace.com

Amgen Fights Fire with Fire in the Biosimilars Market

October 7, 2015 By Mark Terry , BioSpace.com Breaking News Staff Thousand Oaks, Calif.-based Amgen , faced with generic and biosimilars competition as its blockbusters lose patent protection, is fighting back on a number of fronts. On Oct. 2, 2015, Novartis announced that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for its proposed biosimilar to Amgen ’s Enbrel (etanercept). Enbrel is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat various autoimmune disorders, including rheumatoid arthritis and psoriasis. Sandoz, Inc. , a division of Novartis , submitted the BLA using the 351(k) biosimilar pathway. A biosimilar is a drug that acts the same way a known drug does, but has at least a few molecular differences in order to differentiate it from the branded drug. Amgen sells Enbrel in the U.S., and outside the U.S. by Pfizer Inc. . In 2014, Enbrel had sales of $9 billion. Merck & Co. and Samsung Bioepis have approval for biosimilars of Enbrel in South Korea. Samsung and Biogen, Inc. are trying to get approval for a biosimilar to Enbrel in Europe. On Sept. 3, 2015, Sandoz announced that its biosimilar, Zarxio, the first biosimilar approved by the FDA , was to launch in the U.S. Zarxio is a biosimilar to Amgen ’s Neupogen. Zarxio, however, is not approved as an interchangeable biosimilar. This means that the prescribing physician has to specifically prescribe Zarxio instead of Neupogen. Zarxio has entered the market for about 15 percent less than Neupogen . Amgen , in addition to litigation, is fighting fire with fire, and developing its own biosimilars. In Feb., Amgen announced positive results for a Phase III study of ABP 501, a biosimilar to AbbVie ’s Humira (adalimumab) in patients with rheumatoid arthritis. In Oct. 2014, the company announced positive Phase III results for the same compound in moderate-to-severe plaque psoriasis. Just last month, Amgen and Dublin-based Allergan Inc. announced positive results in a Phase III trial for ABP 215, a biosimilar to Roche ’s cancer drug Avastin, used to treat advanced non-squamous non-small cell lung cancer (NSCLC). Although analysts are doubtful these biosimilars will match the sales of their branded counterparts, they have a good chance of becoming blockbusters. That’s probably a win for consumers, which was the intent of the legislation making biosimilars possible in the U.S., but applies significant pressure on biopharma companies. Writing for The Motley Fool, Corey Renauer said, “Difficulties associated with biosimilar development and marketing will no doubt limit the number of players, but competitive pricing pressures will likely prevail. This means that the most profitable biosimilar operations will be the ones that can limit costs. Amgen practically wrote the book on modern biologic manufacturing, and a recently constructed next-generation biomanufacturing facility in Singapore will go a long way toward improving profitability.” In terms of its competition from Novartis , Amgen indicates it’s not done fighting. “We are confident in our Enbrel patent positions, extending to 2029,” said Amgen to BioSpace . “We will seek to enforce our patent rights, in ligitation against Sandoz if necessary, as directed by the provisions of the biosimilars statute.”

Phase 3Clinical ResultDrug ApprovalBiosimilar

100 Deals associated with Tasonermin

External Link

KEGG	Wiki	ATC	Drug Bank
D08562	-	L03AX11	DB11626

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Sarcoma	Norway	Belpharma Sa	12 Apr 1999
Sarcoma	Iceland	Belpharma Sa	12 Apr 1999
Sarcoma	European Union	Belpharma Sa	12 Apr 1999
Sarcoma	Liechtenstein	Belpharma Sa	12 Apr 1999

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECCO2013	Not Applicable	Crohn Disease	-	tumour necrosis factor alpha (Crohn's disease group)	ipzysftdvd(dasjlmfcqw) = dnscyjsfna dmjrofdexh (nsbbjslrrj )	-	01 Feb 2013
ASCO2008	Phase 1/2	Sarcoma	-	TNF-alfa and pegylated liposomal doxorubicin (PLD)	(lgzcivovgu) = ateljldsny ptbwfmpojt (mzcxoublqh ) View more	Positive	20 May 2008
ASCO2007	Not Applicable	Locally Advanced Soft Tissue Sarcoma	100	Isolated Limb Perfusion with Melphalan and TNF-α 1mg	(esbohqyoqu) = no systemic toxicity vskzdrpjts (pesevdztuf )	-	20 Jun 2007
EULAR2001	Not Applicable	Rheumatoid Arthritis	8	Recombinant human TNF-α	puvejbwnhi(lohmzgzxyr) = mtjrvzieik vfiaxtvcbu (zuclfyoscf ) View more	-	13 Jun 2001
EULAR2001	Not Applicable	Rheumatoid Arthritis	8	Recombinant human IL-1b	puvejbwnhi(lohmzgzxyr) = gjtowfvdcg vfiaxtvcbu (zuclfyoscf ) View more	-	13 Jun 2001

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