A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.

Start Date13 Jan 2020

Sponsor / Collaborator

Pfizer Inc.

NCT02480153

/ CompletedPhase 3

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.
In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

Start Date25 Jun 2015

Sponsor / Collaborator

Pfizer Inc.

PER-063-14

/ CompletedPhase 3

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB INCOMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Start Date07 Apr 2015

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Adalimumab-AFZB

100 Translational Medicine associated with Adalimumab-AFZB

100 Patents (Medical) associated with Adalimumab-AFZB

Literatures (Medical) associated with Adalimumab-AFZB

02 Jul 2024·EXPERT OPINION ON BIOLOGICAL THERAPY

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications – an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis

Article

Author: Tennyson, Scott D ; Hufnagel, Heather Rae

PURPOSE:

Evaluate the type and quantity of quality information (i.e. Chemistry, Manufacturing, and Control) requested by the US FDA and EMA in queries pertaining to biosimilar applications.

METHODS:

Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment.

RESULTS:

Queries were most frequently assigned (FDA/EMA %, range) to Drug Substance Manufacture (subsection 3.2.S.2; 21-35%/13-50%), Control of Drug Substance (3.2.S.4; 3-11%/5-17%), Drug Product Pharmaceutical Development (3.2.P.2; 1-12%/1-15%) and Manufacture (3.2.P.3; 17-41%/2-13%), and Analytical Similarity (3.2.R; 4-21%/4-20%). The proportion of Drug Substance and Drug Product queries was significantly different between RAs (n1 = 952, n2 = 468, p-value <0.001; two-sample proportion z-test). Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%).

CONCLUSION:

The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval.

01 Nov 2023·Journal of comparative effectiveness research

Navigating adalimumab biosimilars: an expert opinion

Review

Author: Habauzit, Caroline ; Abitbol, Vered ; Benkhalifa, Salim ; Marotte, Hubert

The patent expiry of Humira ® in 2018 opened up the current European market to eight adalimumab biosimilars – (in alphabetical order) Amgevita ® , Amsparity ® , Hulio ® , Hukyndra ® , Hyrimoz ® , Idacio ® , Imraldi ® and Yuflyma ® – for the treatment of various immune and inflammatory conditions. Amjevita, Hadlima ® , Hyrimoz and Yuflyma have recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humira ends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient–physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.

01 Sep 2023·The Lancet. Rheumatology

Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study

Article

Author: Lakhanpal, Sharad ; Cronenberger, Carol ; Alvarez, Daniel F ; Fleischmann, Roy M ; Ianos, Claudia Ana ; Saikali, Wassim ; Cox, Donna S ; Wang, Karen ; Zhang, Wuyan

BACKGROUND:

An adalimumab biosimilar with an interchangeability designation could increase access to effective treatment for more patients. We aimed to assess the interchangeability of adalimumab biosimilar PF-06410293 (adalimumab-afzb) and reference adalimumab using a multi-switch study design.

METHODS:

We did an open-label, randomised, parallel-group study at 61 community (n=29), hospital (n=12), and academic (n=20) sites in ten countries (Bulgaria, Bosnia and Herzegovina, Czech Republic, Lithuania, Poland, Russia, Serbia, South Africa, Ukraine, and USA). Eligible patients were aged 18-70 years and met the 2010 American College of Rheumatology-European League Against Rheumatism classification criteria for rheumatoid arthritis for at least 4 months with moderately to severely active rheumatoid arthritis, based on their physician's evaluation. Eligible patients had been receiving methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks before the first dose of study medication. All patients received subcutaneous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks) for 10 weeks before randomisation. At week 10, patients were randomly assigned (1:1) to either three switches between subcutaneous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks) and adalimumab-afzb (40 mg/0·8 mL [50 mg/mL] every 2 weeks; switching group), or continuous dosing with subcutanous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks; non-switching group) with stratification by bodyweight groups. Patients, investigators, and site personnel were not masked to treatment allocation. Primary endpoints were maximum observed serum concentration (C_max) and area under plasma concentration-time curve (AUC_τ) during weeks 30-32 in the pharmacokinetic population. Interchangeability was based on geometric mean ratios and corresponding 90% CIs within prespecified equivalence margins of 80-125% for both primary endpoints. Safety was analysed in all patients who received at least one dose of adalimumab-afzb or reference adalimumab. This trial is registered with ClinicalTrials.gov, NCT04230213.

FINDINGS:

Of the 569 patients assessed for eligibility between Jan 13, 2020, and June 22, 2021, 445 were enrolled, and 427 completed the first 10 weeks and were randomly assigned (213 to the switching group and 214 to the non-switching group). Participants had a median age of 56 years (IQR 46-63), 354 (83%) of 427 patients were women and 73 (17%) were men, and 422 (99%) were White. In the pharmacokinetic population (n=380), no clinically meaningful differences were observed in mean steady-state pharmacokinetic parameters between the switching and non-switching groups (geometric mean AUC 2237 μg × h/mL in the switching group and 2125 μg × h/mL in the non-switching group; C_max 8·21 μg/mL in the switching group and 8·00 μg/mL in the non-switching group). Geometric mean ratios and 90% CIs for AUC_τ (105·31, 89·16-124·39) and C_max (102·56, 89·78-117·17) were within prespecified equivalence margins. No meaningful differences were observed in the proportion of patients who had serious adverse events (three [1%] of 213 patients in the switching group vs eight [4%] of 214 patients in the non-switching group), grade 3 or higher adverse events of special interest, discontinuations due to adverse events (eight [4%] vs nine [4%]), or immunogenic reactions in antidrug antibody-positive patients. No deaths were reported during the study.

INTERPRETATION:

The risk of multiple switches between reference adalimumab and adalimumab-afzb with respect to diminished efficacy (using pharmacokinetics as a surrogate) or safety is not greater than the risk of using reference adalimumab alone.

FUNDING:

Pfizer. VIDEO ABSTRACT.

News (Medical) associated with Adalimumab-AFZB

10 Jan 2024

·www.biospace.com

Henlius and Sermonix Announce Strategic Collaboration and Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene

Partnership expands Henlius’ portfolio with license of exclusive China rights to develop, manufacture and commercialize lasofoxifene; Sermonix retains all other global rights Henlius to facilitate clinical development for the initiated Phase 3 MRCT (ELAINE-3) of lasofoxifene in the territory Sermonix receives upfront payment, milestone payments of up to $58M and royalties upon commercialization in the territory COLUMBUS, Ohio and SHANGHAI, China, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China. “In Phase 2 clinical trials, investigational lasofoxifene demonstrated its potential for the treatment of ER+/HER2- breast cancer harboring ESR1 mutation,” said Ping Cao, senior vice president and chief business development officer of Henlius. “Lasofoxifene will play a critical role in complementing Henlius' pipeline of its breast cancer product. In collaboration with Sermonix, we look forward to accelerating the access of more effective, personalized, precise and well-tolerated treatment solutions for Chinese patients.” “With a strong platform of R&D resources and commercialization capabilities, Henlius is an ideal partner to bring lasofoxifene into the therapeutic landscape in China,” said Dr. David Portman, Sermonix founder and chief executive officer. “Previous studies demonstrated lasofoxifene’s best-in-class potential and we will work with Henlius to accelerate the clinical development of the Phase 3 ELAINE-3 multi-regional clinical trial in China, making lasofoxifene available to Chinese patients as soon as possible." Breast cancer is the cancer with the highest incidence rate in the world, according to GLOBOCAN 2020. There were 2.26 million new cases of breast cancer in 2020 globally, including more than 410,000 in China [1]. ER+ breast cancer comprises 60-70% of all breast cancers [2]. Endocrine therapy remains the mainstay treatment for ER+ breast cancer and the most widely used class of aromatase inhibitor (AI) has been recommended by the National Comprehensive Cancer Network (NCCN) and Chinese Society of Clinical Oncology (CSCO) guidelines to be the adjuvant and first-line standard of care for patients with ER+/HER2- breast cancer [3-4]. However, almost all patients treated with AIs develop primary or acquired resistance [5], with acquired mutations in the estrogen receptor α gene (ESR1) being the most prevalent (up to 40%). This is a significant mechanism of resistance to endocrine therapy [6]. Currently, there are limited treatment options for ER+/HER2- breast cancer with ESR1 mutations, and thus a large clinical need exists. The Phase 3 ELAINE-3 multi-regional clinical trial (NCT05696626) is the third of Sermonix’s Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies. With the Phase 2 ELAINE-1 and ELAINE-2 studies both completed and having shown compelling anti-tumor activity against tumors with increasingly prevalent ESR1 mutations [7-8], Sermonix in December 2023 activated and began enrollment for ELAINE-3 in the U.S. ELAINE-3 will assess the efficacy of lasofoxifene and Eli Lilly and Company’s (NYSE:lly) CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. Henlius will fund the clinical development and patient enrollment of the ELAINE-3 study in China, and be responsible for regulatory approval and post-marketing manufacturing and commercialization in the region. About Lasofoxifene Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy, could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug development, strategic partnerships and commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn more at SermonixPharma.com. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 2 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. References: [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and MortalityWorldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. [2] Ignatiadis M, Sotiriou C. Luminal breast cancer: from biology to treatment[J]. Nat Rev Clin Oncol, 2013, 10(9): 494-506. doi: 10.1038/nrclinonc.2013.124. [3] Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines 2023 [4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2023 [5] Rozeboom B, Dey N, De P. ER+ metastatic breast cancer: past, present, and a prescription for an apoptosis-targeted future. Am J Cancer Res. 2019;9(12):2821-2831. Published 2019 Dec 1. [6] Spoerke JM, Gendreau S, Walter K, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun. 2016;7:11579. Published 2016 May 13. doi:10.1038/ncomms11579 [7] Goetz MP, Bagegni NA, Batist G, et al. Lasofoxifene versus fulvestrant for ER+/HER2- metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial. Ann Oncol. 2023;34(12):1141-1151. doi:10.1016/j.annonc.2023.09.3104 [8] S. Damodaran, C.C. O’Sullivan, A. Elkhanany, I.C. Anderson, M. Barve, S. Blau, M.A. Cherian, J.A. Peguero, M.P. Goetz, P.V. Plourde, D.J. Portman, H.C.F. Moore, Open-label, phase II, multicenter study of lasofoxifene plus abemaciclib for treating women with metastatic ER+/HER2− breast cancer and an ESR1 mutation after disease progression on prior therapies: ELAINE 2. Ann Oncol. 2023;34(12):1131-1140. doi:10.1016/j.annonc.2023.09.3103. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832 Henlius Contact: Bella Zhou/Janice Han PR@henlius.com

Phase 2License out/inDrug ApprovalPhase 3Clinical Result

09 Oct 2023

·endpts.com

Setting up a showdown with Boehringer, Pfizer scores interchangeability tag for its Humira biosimilar

Beginning later this month, Pfizer is launching an interchangeable biosimilar to AbbVie’s blockbuster rheumatoid arthritis drug Humira (adalimumab) at a 5% discount on the wholesale acquisition price. Later in 2023, Pfizer said late last week, its interchangeable biosimilar known as Abrilada (adalimumab-afzb) will be available at a second list price of 60% below the Humira list price. By contrast, Boehringer Ingelheim, which is the only other company with an interchangeable Humira biosimilar on the market so far, confirmed that its lowest-cost version of its interchangeable known as Cyltezo launched on Oct. 2 with an 81% discount. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

BiosimilarDrug ApprovalAcquisition

20 Sep 2023

·www.biopharmadive.com

Alvotech gets new FDA review for Humira biosimilar

Dive Brief:The Food and Drug Administration is reviewing Alvotechs newest application for its Humira biosimilar, setting a Feb. 24 deadline to decide on approval, the company said Wednesday. The regulator has twice rejected the drug because of manufacturing issues at an Iceland plant.Alvotech said its latest approval application contains additional information on the methods used to measure quality and consistency at that plant to address manufacturing facility deficiencies identified earlier by the FDA.If the decision is positive, the Iceland-based drugmaker will be more than a year behind the first U.S. Humira biosimilar launched by Amgen and seven months behind a wave that hit the market at mid-year. Alvotech had been banking on its product being one of the first interchangeable Humira biosimilars meaning it can be substituted by pharmacists although that advantage could diminish by the time it launches.Dive Insight:The expiration of AbbVies key patents on Humira earlier this year has led to a rush of biosimilar makers hoping to grab a share of the $18.6 billion in U.S. sales it recorded last year. Alvotech, which is partnered with generics giant Teva, was in the running for a slice of that revenue until regulatory hurdles got in the way, exacerbated by the FDAs inability to complete plant inspections during the COVID-19 pandemic.The initial setback came a year ago, when the FDA first identified manufacturing deficiencies. At the time, Alvotech said it intended to resolve the problems by December 2022, by which time a separate approval application seeking interchangeability was supposed to have a verdict from the FDA.In April, the FDA again rejected Alvotech's main approval application, based on deficiencies it spotted during a March inspection. And for good measure, it also knocked down the company's second attempt at an interchangeability approval just before it had the legal right to launch its biosimilar on July 1.Missing out on that revenue stream meant Alvotech needed to raise money. It would go on to bring in $140 million from Teva and other investors and other investors while also stepping up its involvement in getting the Iceland plant FDA-compliant.Alvotech is leaning heavily on its possible status as the only high-concentration interchangeable Humira biosimilar. Boehringer has won interchangeability status for its low-concentration drug named Cyltezo and Pfizer could earn the same status for its low-concentration biosimilar, called Abrilada, by the end of the year.In the meantime, big pharmacy benefit managers have already made deals with other biosimilar makers, increasing Alvotechs entry challenges. Cigna Healthcares Express Scripts and United Healthcares Optum have chosen Cyltezo, Amgens Amjevita and Novartis Hyrimoz, along with an unbranded Novartis biosimilar.CVS Health, meanwhile, has chosen a private label version of Hyrimoz and has also announced its intention to become more deeply involved in biosimilar commercialization. '

Accelerated ApprovalBiosimilarDrug Approval

100 Deals associated with Adalimumab-AFZB

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KEGG	Wiki	ATC	Drug Bank
-	Adalimumab-AFZB	L04AB04	DB00051

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Polyarticular Juvenile Idiopathic Arthritis	Australia	Pfizer Australia Pty Ltd.	22 Feb 2021
Axial Spondyloarthritis	European Union	Pfizer Europe MA EEIG	13 Feb 2020
Axial Spondyloarthritis	Iceland	Pfizer Europe MA EEIG	13 Feb 2020
Axial Spondyloarthritis	Liechtenstein	Pfizer Europe MA EEIG	13 Feb 2020
Axial Spondyloarthritis	Norway	Pfizer Europe MA EEIG	13 Feb 2020
Enthesitis-Related Arthritis	European Union	Pfizer Europe MA EEIG	13 Feb 2020
Enthesitis-Related Arthritis	Iceland	Pfizer Europe MA EEIG	13 Feb 2020
Enthesitis-Related Arthritis	Liechtenstein	Pfizer Europe MA EEIG	13 Feb 2020
Enthesitis-Related Arthritis	Norway	Pfizer Europe MA EEIG	13 Feb 2020
Hidradenitis Suppurativa	European Union	Pfizer Europe MA EEIG	13 Feb 2020
Hidradenitis Suppurativa	Iceland	Pfizer Europe MA EEIG	13 Feb 2020
Hidradenitis Suppurativa	Liechtenstein	Pfizer Europe MA EEIG	13 Feb 2020
Hidradenitis Suppurativa	Norway	Pfizer Europe MA EEIG	13 Feb 2020
Non-infectious anterior uveitis	European Union	Pfizer Europe MA EEIG	13 Feb 2020
Non-infectious anterior uveitis	Iceland	Pfizer Europe MA EEIG	13 Feb 2020
Non-infectious anterior uveitis	Liechtenstein	Pfizer Europe MA EEIG	13 Feb 2020
Non-infectious anterior uveitis	Norway	Pfizer Europe MA EEIG	13 Feb 2020
Pediatric Crohn's Disease	European Union	Pfizer Europe MA EEIG	13 Feb 2020
Pediatric Crohn's Disease	Iceland	Pfizer Europe MA EEIG	13 Feb 2020
Pediatric Crohn's Disease	Liechtenstein	Pfizer Europe MA EEIG	13 Feb 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04230213 (Pubmed)	Phase 3	Rheumatoid Arthritis	445	Reference adalimumab	zsdtwvlzdu(tvzclqdoca) = mvphrwtlqp zunvxywkuc (aqwlzibtzh )	Positive	01 Sep 2023
				Adalimumab-afzb	zsdtwvlzdu(tvzclqdoca) = ynruqzdgeh zunvxywkuc (aqwlzibtzh )
NCT04230213 (CTgov)	Phase 3	Rheumatoid Arthritis	455	Adalimumab+Humira (Switching Arm: Humira and PF-06410293 (Adalimumab))	thpyuakyvd(jzfwmkxosj) = dwargzaxik oicvvnjspt (yrnlruxmwt, 97) View more	-	22 Aug 2022
				Humira (Adalimumab) (Non-switching Arm: Humira (Adalimumab))	thpyuakyvd(jzfwmkxosj) = tghaiwcwam oicvvnjspt (yrnlruxmwt, 97) View more
NCT02480153 (REFLECTIONS B538-02, Pubmed \| Arthritis Res Ther)	Phase 3	Rheumatoid Arthritis	507	ADL-PF	nqzdzeghht(invbtrocfe) = qwepwedwve bcwhpstrfa (nhkzvllvbq )	-	01 Dec 2021
NCT02480153 (Pubmed \| RMD Open)	Phase 3	Rheumatoid Arthritis	413	PF-06410293	liaxvbvlhe(ywphefajky) = nbublaiwfo qbmrghlfbq (pgjdrddkoz ) View more	Positive	01 Apr 2021
				EU-sourced reference ADL	liaxvbvlhe(ywphefajky) = twppwxdfyi qbmrghlfbq (pgjdrddkoz ) View more
NCT02480153 (not available, EULAR2020)	Phase 3	Rheumatoid Arthritis	597	ADL-PF	tgadqfqbxu(myocezxnwc) = oaialkbcfq qlvqfmluxp (rxrfxvibbw )	Positive	03 Jun 2020
				ADL-EU	tgadqfqbxu(myocezxnwc) = xygzfpqrmh qlvqfmluxp (rxrfxvibbw )
NCT02480153 (Pubmed \| Arthritis Res Ther) Manual	Phase 3	Rheumatoid Arthritis	597	PF-06410293	midmgesvre(ntldhazuha) = foilocqojw mabonsoswc (eyfkvbhorv )	Similar	15 Aug 2018
				adalimumab	midmgesvre(ntldhazuha) = nliluvpeoi mabonsoswc (eyfkvbhorv )
EULAR2018	Not Applicable	Rheumatoid Arthritis	597	PF-06410293	hiprwxhohy(lpvnuuqnsb) = nxuxxqqfqz mckpwslblg (xuomtprzvr ) View more	-	13 Jun 2018
				ADA-EU	hiprwxhohy(lpvnuuqnsb) = bglduqokrt mckpwslblg (xuomtprzvr ) View more
NCT02480153 (REFLECTIONS B538-02 \| not available, CTgov)	Phase 3	Rheumatoid Arthritis	597	PF-06410293 (Period 1: PF-06410293)	hwoagjuohe = cfvfpnmwjc iefemkgong (fxezhuomgk, dnlztrfyqa - mzjxuqjpod) View more	-	26 Sep 2017
				Adalimumab (Period 1: Adalimumab-EU)	hwoagjuohe = mvuahkqcqz iefemkgong (fxezhuomgk, naugmfgwpn - azsnowxrsz) View more
EULAR2017	Phase 3	Arthritis, Psoriatic	422	Tofacitinib 5 mg BID	ciwmvpsppw(kleegzyvcv) = ozykxnwaym gzozoeploa (ybziosabmk )	-	14 Jun 2017
				Tofacitinib 10 mg BID	ciwmvpsppw(kleegzyvcv) = ltwuqmtnyu gzozoeploa (ybziosabmk )
EULAR2012	Phase 3	Rheumatoid Arthritis	-	Tofacitinib 5 mg BID	eqzxbzzckm(qnxynqkncy) = npfmbkrqyl twvvuhnxxr (ydxhktmjpf ) View more	-	06 Jun 2012
				Tofacitinib 10 mg BID	eqzxbzzckm(qnxynqkncy) = pkvetdylpz twvvuhnxxr (ydxhktmjpf ) View more

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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AI Agents Built for Biopharma Breakthroughs

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis