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

07 Apr 2026

·firstwordpharma.com

Biopharma bites: New additions to TrumpRx, a suite of deals from Biogen, Lilly and Vertex, plus Renovare's launch

Humira joins its biosimilars on TrumpRxBiogen joins forces with Alloy on antisense platformLilly amends tau tie-up with AC ImmuneVertex partners with Halozyme on drug-delivery techRenovare launches to develop regenerative osteoarthritis therapiesHumira joins its biosimilars on TrumpRxAbbVie's former megablockbuster Humira (adalimumab) has made its debut on TrumpRx, where patients can purchase a month's supply of the anti–TNF-α mAb for $950 in cash. While the pricetag is an 86% discount from Humira's nearly-$7000 list price, the government-run direct-to-consumer (DTC) site also offers a pair of Humira biosimilars at half, or less, the price of the name-brand autoimmune disease drug. Pfizer's biosimilar, Abrilada (adalimumab-afzb) is available for $415.20 per month, and Amgen's Amjevita (adalimumab-atto) has a monthly cash-pay price of $299.Meanwhile, Gilead's flu medication, Xofluza (baloxavir marboxil), was also listed on TrumpRx this week for $50, matching the cash-pay price offered on the drugmaker's DTC platform.-Elizabeth EatonBiogen joins forces with Alloy on antisense platformAs part of a deal announced Tuesday, Biogen will use Alloy Therapeutics' AntiClastic antisense oligonucleotide (ASO) platform to advance antisense therapeutics against multiple undisclosed targets. Alloy is eligible to receive an undisclosed upfront payment, as well as milestones and tiered royalties on products resulting from the collaboration.The AntiClastic ASO platform is designed to address potency and therapeutic index challenges that have historically held back the promise of antisense drugs due to limited biodistribution. Alloy noted that the platform enables drug developers to realise the full potential of antisense therapeutics by reaching intracellular disease targets at the RNA level. "This collaboration reflects Biogen's commitment to pushing the boundaries of scientific innovation and exploring novel approaches to address complex diseases," said Jane Grogan, Biogen's head of research.-Matthew DennisLilly amends tau tie-up with AC ImmuneEli Lilly and AC Immune have amended their 2018 collaboration to develop small molecule tau aggregation inhibitors for Alzheimer's disease and other neurodegenerative disorders, adding new lead and back-up Morphomer Tau candidates — which are able to enter the brain when dosed orally and bind to the protein's pathological conformation — to the collaboration. According to AC Immune, Morphomer small molecules can target intracellular tau, and "strong preclinical data" suggest they "should be clinically relevant for inhibiting aggregation and seeding across pathological and disease stages." IND-enabling studies are slated to begin this half.Under the amended deal, AC Immune will receive CHF10 million ($12.5 million) upfront and an extra milestone payment upon Phase I dosing, in addition to milestones announced in a previous deal revision. The company remains eligible for further development, regulatory and commercial milestones exceeding CHF1.7 billion ($2.1 billion), along with tiered royalty payments.-Anna BratulicVertex partners with Halozyme on drug-delivery techVertex Pharmaceuticals has licensed Halozyme Therapeutics' Hypercon microparticle technology for use in up to three drug targets, the companies announced Tuesday. "We are pleased to add…[the] drug-delivery technology to our toolbox as we pursue transformative therapies for patients with serious diseases," said Mark Bunnage, chief scientific officer of Vertex.The Hypercon technology allows for hyperconcentration of drugs and biologics, thus reducing injection volume for the same dosage and enabling at-home administration. The technology has previously been licensed to argenx, Eli Lilly and Johnson & Johnson's Janssen unit.Under the deal, Vertex will make a $15 million upfront payment to Halozyme and is on the hook for undisclosed milestones, with the latter also entitled to sales royalties on products developed using the Hypercon technology.-Matthew DennisRenovare launches to develop regenerative osteoarthritis therapiesRenovare Therapeutics emerged from stealth on Monday, announcing a collaboration with the University of Colorado (CU) Boulder under a US government contract worth up to $33.5 million to develop regenerative treatments for osteoarthritis.The funding, awarded by the Advanced Research Projects Agency for Health (ARPA-H) under its Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) programme, will support IND-enabling and Phase I safety studies for Renovare's lead assets. These therapies aim to be regenerative, potentially halting and reversing disease progression."With Renovare’s technologies having broad applicability beyond osteoarthritis, we are excited to build a biotechnology company of significant value to patients, providers, and community stakeholders," said CEO Liz Scott.-Pavan Kamat

License out/inPhase 1

18 Mar 2026

·www.fiercepharma.com

TrumpRx's 'world's lowest' drug price claims fall short in global comparison: NYT

President Donald Trump's TrumpRx drug purchasing platform pledges the “lowest cash prices" for 54 drugs. Much of President Donald Trump’s campaign promises to lower drug prices in the U.S. were said to have been delivered through TrumpRx, a recently launched direct-to-consumer platform built on most-favored-nation pricing that benchmarks domestic prices against international rates.But, according to a new report from The New York Times, TrumpRx’s claims of offering “the world's lowest prices on prescription drugs” might have some caveats. A review conducted by the NYT and German news organizations Süddeutsche Zeitung, NDR and WDR found that drug prices in Germany were lower than many listed on TrumpRx when directly compared. Last May, the president issued an executive order mandating MFN drug pricing while calling out “inflated prices” in the U.S. that force American patients to pay “almost three times more” for the same medicines than those in other developed nations. Trump, in a Truth Social post at the time, insisted that this order would see prescription drug prices reduced by 30% to 80%. Seventeen of the world’s largest drugmakers were then sent letters that demanded them to match their U.S. drug prices with other nations’ and to sell their products through DTC platforms. Pfizer was the first to sign on to the arrangement, with its peers following suit. In February, Trump wrapped his MFN pricing deals into action with the launch of drug purchasing platform TrumpRx. The website states that “the days of Big Pharma price-gouging are over” and assures that the president has “ensured every American gets the lowest prices on prescription medicine in the developed world.”To illustrate its point, the site displays a side-by-side of EMD Serono’s fertility treatment Gonal-f at its previous price and its new MFN price compared to its price in Canada, which is listed as a “global reference.” The NYT, however, put this claim to the test. When looking at worldwide drug prices for Novo Nordisk’s popular Wegovy, the TrumpRx price for the injection is in fact lower than Canada’s but remains higher than the cost in seven other countries including Germany, Britain and Japan, the news org found. When comparing German prices specifically, the price discrepancy was the starkest for branded drugs that still have patent protection, such as Pfizer’s hormone treatment Ngenla. For two injection pens of that drug, the German public health system pays $2,723 less than a patient using TrumpRx discounts would, according to the report, which used data from German health insurance provider AOK. That said, Pfizer’s Humira biosimilar Abrilada goes for $500 less on TrumpRx than it would in Germany, before discounts, according to the NYT. Meanwhile, the investigation determined that patients without insurance are paying the lowest out-of-pocket prices for obesity drugs such as Eli Lilly’s Zepbound in Japan, with a four-week supply available for $155 versus $399 on TrumpRx. In response, White House officials told the NYT that TrumpRx prices can still be cheaper than those of other countries even with a listed price difference when accounting for the economic conditions in each country, a point that Eli Lilly further endorsed.“A dollar goes further in some countries than others,” Lilly spokesperson Misty Fuller told the news org. “A medicine isn’t necessarily cheaper abroad if wages and living costs are lower there.” TrumpRx callouts Trump’s broad claims of “huge savings,” as TrumpRx mentions, have been scrutinized by lawmakers as well. A late February report (PDF) from democrats on the U.S. House of Representatives’ Energy and Commerce Committee found that cheaper generic drugs are available for at least 15 drugs listed on the website and that drug savings platform GoodRx had already offered the same discount for at least seven medicines touted on the site. “At best, the platform offers discount coupons that are readily available elsewhere. At worst, it appears to intentionally withhold information about more affordable generic alternatives and in some instances even charges consumers more than if they purchased the drug directly from the manufacturer,” ranking committee member Frank Pallone, D-N.J., commented, calling the website “not a serious effort to lower prescription drug prices.”The lawmakers’ qualms are shared by the Center for American Progress, which found that, when accounting for GoodRx prices, lower-cost generics and existing manufacturer coupons, only one drug available on TrumpRx, EMD Serono’s Cetrotide, offers a price not previously accessible to cash-paying patients. TrumpRx currently touts 54 drugs, available at the “lowest cash prices.” As the website does not sell the products directly, much of the medicine listed on the site can be purchased through the respective direct-to-patient platforms run by drugmakers, while others offer TrumpRx coupons that can be presented at the pharmacy. The website uses GoodRx as a “core integration partner,” GoodRx said at the time of launch. GoodRx’s role is to offer drugmakers a “scalable way” to extend discounted cash prices to TrumpRx, allowing them to “rapidly operationalize most favored nation (MFN) and other policy-aligned pricing programs at national scale.” Either way, the only patients who stand to benefit from any TrumpRx savings are those who self-pay at the pharmacy, leaving out the 85% of the U.S. population that has prescription drug insurance coverage, University of Washington health economics and policy professors Sean Sullivan, Ph.D., and Ryan Hansen, Ph.D., pointed out in a Stat opinion piece last month. As the professors put it, the “real winners” at play are the pharmaceutical manufacturers themselves, which can “preserve their ability to maintain higher prices while appearing magnanimous through selective discounting.”

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

100 Deals associated with Adalimumab-AFZB

External Link

KEGG	Wiki	ATC	Drug Bank
-	Adalimumab-AFZB	L04AB04	DB00051

R&D Status

10 top approved records.

to view more data

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

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04230213 (Pubmed)	Phase 3	Rheumatoid Arthritis	445	Reference adalimumab	ubegqkzwfw(emnouldlvk) = fyilikjull gmarlngqlq (etzzsvycmv )	Positive	01 Sep 2023
				Adalimumab-afzb	ubegqkzwfw(emnouldlvk) = srelokwput gmarlngqlq (etzzsvycmv )
NCT04230213 (CTgov)	Phase 3	Rheumatoid Arthritis	455	Adalimumab+Humira (Switching Arm: Humira and PF-06410293 (Adalimumab))	fcxtjghokg(eiufkghgoi) = igvgxiyrzl hadnfhyscw (aimfvzvsvw, 97) View more	-	22 Aug 2022
				Humira (Adalimumab) (Non-switching Arm: Humira (Adalimumab))	fcxtjghokg(eiufkghgoi) = heerczzjtj hadnfhyscw (aimfvzvsvw, 97) View more
NCT02480153 (REFLECTIONS B538-02, Pubmed \| Arthritis Res Ther)	Phase 3	Rheumatoid Arthritis	507	ADL-PF	gwxoabrqtz(kyaucxtzsw) = zqyqcwucxx exvsxjlfay (wyguymwzzu )	-	01 Dec 2021
NCT02480153 (Pubmed \| RMD Open)	Phase 3	Rheumatoid Arthritis	413	PF-06410293	ckndjmqukw(herhuyzhim) = drawkgilhc hygvftjdws (qucjhishju ) View more	Positive	01 Apr 2021
				EU-sourced reference ADL	ckndjmqukw(herhuyzhim) = zmtwhngpcf hygvftjdws (qucjhishju ) View more
NCT02480153 (not available, EULAR2020)	Phase 3	Rheumatoid Arthritis	597	ADL-PF	cwbbdbewsl(crayedunfr) = dgwbqnakgn eqpqncmbvv (lzuzinnwgq )	Positive	03 Jun 2020
				ADL-EU	cwbbdbewsl(crayedunfr) = ittotgdgck eqpqncmbvv (lzuzinnwgq )
NCT02480153 (Pubmed \| Arthritis Res Ther) Manual	Phase 3	Rheumatoid Arthritis	597	PF-06410293	qipexdhouw(kywdmmutnr) = ihmimyhkqc bweoxijina (rdwzptvyvn )	Similar	15 Aug 2018
				adalimumab	qipexdhouw(kywdmmutnr) = lqtjgoysot bweoxijina (rdwzptvyvn )
EULAR2018	Not Applicable	Rheumatoid Arthritis	597	PF-06410293	prezmxxbvj(kjoybxmacg) = dmbzmkwkzo cftfsjbaqk (uzijjfkemr ) View more	-	13 Jun 2018
				ADA-EU	prezmxxbvj(kjoybxmacg) = saerpjoiai cftfsjbaqk (uzijjfkemr ) View more
NCT02480153 (REFLECTIONS B538-02 \| not available, CTgov)	Phase 3	Rheumatoid Arthritis	597	PF-06410293 (Period 1: PF-06410293)	obfficrinm = wtpwiljfir venfldvpar (fvxookbvdn, jaqpiqczsk - ihcdhktjif) View more	-	26 Sep 2017
				Adalimumab (Period 1: Adalimumab-EU)	obfficrinm = yamuznzurq venfldvpar (fvxookbvdn, rxnzaefbhb - njjciyhapb) View more
EULAR2017	Phase 3	Arthritis, Psoriatic	422	Tofacitinib 5 mg BID	blxouqwxpd(brjcvhnpyj) = jouescnxeg fmzowlfwyq (rbfozfjaqj )	-	14 Jun 2017
				Tofacitinib 10 mg BID	blxouqwxpd(brjcvhnpyj) = qpmrzrwfvj fmzowlfwyq (rbfozfjaqj )
EULAR2012	Phase 3	Rheumatoid Arthritis	-	Tofacitinib 5 mg BID	zclgmarjkl(jcploctaxs) = lkjxodqhyn ieekeudkhc (unmngengdd ) View more	-	06 Jun 2012
				Tofacitinib 10 mg BID	zclgmarjkl(jcploctaxs) = wvuybvnzap ieekeudkhc (unmngengdd ) View more

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