A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

Start Date03 Jun 2021

Sponsor / Collaborator

Alvotech Swiss AG

NCT04744363

/ CompletedPhase 1

Phase 1, FIH, Randomized, Double-blind, Single-dose, Parallel-group, 3-arm Study Comparing the PK, Safety, Tolerability, and Immunogenicity Profiles of AVT04, EU-approved Stelara®, and US-licensed Stelara® in Healthy Adult Subjects

Protocol Title:
A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects
Short Title:
A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects
Rationale:
Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.

Start Date25 May 2021

Sponsor / Collaborator

Alvotech Swiss AG

[+1]

100 Clinical Results associated with Ustekinumab biosimilar (Alvotech)

100 Translational Medicine associated with Ustekinumab biosimilar (Alvotech)

100 Patents (Medical) associated with Ustekinumab biosimilar (Alvotech)

Literatures (Medical) associated with Ustekinumab biosimilar (Alvotech)

01 Jul 2024·Clinical Drug Investigation

AVT04: An Ustekinumab Biosimilar

Review

Author: Blair, Hannah A

AVT04 (Uzpruvo^®) is a biosimilar of the reference anti-interleukin (IL)-12 and IL-23 monoclonal antibody ustekinumab. It is approved in the EU for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn's disease as per the reference product. AVT04 has similar physicochemical characteristics to those of reference ustekinumab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate to severe chronic plaque psoriasis. AVT04 demonstrated clinical efficacy similar to that of reference ustekinumab in patients with moderate to severe chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT04 were similar to those of reference ustekinumab, and switching from reference ustekinumab to AVT04 had no impact on efficacy, safety or immunogenicity. The role of reference ustekinumab in the management of inflammatory diseases is well established and AVT04 provides an effective biosimilar alternative for patients requiring ustekinumab therapy.

03 Aug 2023·Expert opinion on biological therapy

Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis

Article

Author: Otto, Hendrik ; Berti, Fausto ; Stroissnig, Heimo ; Feldman, Steven R ; Haliduola, Halimu N ; Duijzings, Paul ; Leutz, Steffen ; Ruffieux, Ruth ; Reznichenko, Nataliya

BACKGROUND:

This study compared efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity between AVT04 and reference product (RP) ustekinumab (Stelara®) in patients with moderate-to-severe chronic plaque psoriasis (PsO).

PATIENTS AND METHODS:

This multicenter, double-blind, 52-week study randomized patients in 1:2 ratio to AVT04 or RP. At week 16, responsive patients (≥50% improvement in psoriasis area and severity index (PASI)) previously on AVT04 continued on AVT04, while those on RP were re-randomized 1:1 to switch to AVT04 or stay on RP. The primary endpoint was a percent improvement in PASI from baseline to week 12. Therapeutic equivalence was demonstrated if the confidence interval (CI) for the adjusted difference in means was contained within the equivalence margins; ±10% (90%CI).

RESULTS:

Of the 581 patients initially randomized (AVT04:RP, 194:387), 575 completed week 16 and 544 completed end of study visit. The percent PASI improvement for AVT04 vs RP was 87.3% vs 86.8% (CI: -2.14%, 3.01%); study met its primary endpoint. Efficacy, safety and PK profiles were comparable across treatment arms throughout the entire study duration, and the incidence of antibodies to ustekinumab had no clinically meaningful impact.

CONCLUSION:

This study demonstrates the therapeutic equivalence between AVT04 and RP in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.

TRIAL REGISTRATION:

NCT04930042; EudraCT Number: 2020-004,493-22.

04 May 2023·Expert opinion on investigational drugs

A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults

Article

Author: Otto, Hendrik ; Hamilton, Paul ; Haliduola, Halimu N ; Wynne, Christopher ; Duijzings, Paul ; McLendon, Kristi ; Smith, Matthew ; Stroissnig, Heimo ; Berti, Fausto ; Sattar, Abid ; Ruffieux, Ruth ; Leutz, Steffen

BACKGROUND:

This study assessed pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT04, a candidate biosimilar, compared with reference product (RP) ustekinumab (EU-approved and US-licensed Stelara®).

METHODS:

Healthy subjects (N = 298) were randomized 1:1:1 to receive one 45 mg dose of AVT04, EU-RP, or US-RP. The primary PK parameters were Cmax and AUC0-inf. PK similarity was demonstrated if the 90% confidence intervals (CI) for the ratio of geometric means were all contained within the prespecified margins of 80% and 125%. Additional PK parameters, including AUC0-t, were also assessed. Safety and immunogenicity were also assessed until Day 92.

RESULTS:

After pre-specified protein content normalization, the 90% CI for the ratio of geometric means for primary PK parameters were all contained within the pre-specified bioequivalence margins of 80% and 125%, supporting demonstration of PK similarity between AVT04 and both EU- and US-RP. Secondary PK parameters supported the analysis. Safety and immunogenicity profiles were comparable across all three treatment arms, although the study was not powered to detect small differences in these parameters.

CONCLUSION:

Results supported a demonstration of PK similarity between candidate biosimilar AVT04, US-RP and EU-RP. Similar safety and immunogenicity were also shown.Clinical trial registration: www.clinicaltrials.gov identifier is NCT04744363.

112

News (Medical) associated with Ustekinumab biosimilar (Alvotech)

09 Jul 2025

·www.globenewswire.com

Alvotech Expands its Capacity in Assembly and Packaging with the Acquisition of Ivers-Lee in Switzerland

REYKJAVIK, Iceland and BURGDORF, Switzerland, July 09, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the expansion of its capacity for assembly and packaging with the acquisition of Ivers-Lee Group (“Ivers-Lee”), a family owned business with headquarters in Burgdorf, Switzerland specializing in providing high-quality assembly and packaging services for the pharmaceutical sector. While Ivers-Lee will remain a separate legal entity, its operations will be integrated into Alvotech’s Technical Operations division, supporting Alvotech’s ambitious plans for growth. “Ivers-Lee has been an Alvotech preferred partner in assembly and packaging for several years. We know and trust each other very well, having worked closely together. As Alvotech prepares for the launch of three new biosimilars in 2025 and sales growth in global markets, the integration of Ivers-Lee into our Technical Operations, provides added flexibility and capacity to meet increased global demand for our biosimilars, maintaining the highest level of quality and service,” said Robert Wessman, founder, chairman and CEO of Alvotech. Ivers-Lee was founded in Burgdorf, Switzerland in 1947, to supply innovative packaging services for the pharmaceutical sector. In addition to the site in Burgdorf, Ivers-Lee also operates a strategic business unit in Lörrach, Germany. Managing director Peter Schüpbach, grandson of Ivers-Lee’s founder, will remain managing director and member of the Board of Directors of Ivers-Lee Group. Furthermore, he will join the Technical Operations senior leadership team of Alvotech following the acquisition. “Alvotech offers the Ivers-Lee Group financial strength and development opportunities in a growth market, that we as a founding family cannot offer. This change brings stability both for Ivers-Lee and its employees,” said Peter Schüpbach. Ivers-Lee’s site in Burgdorf is GMP licensed, and FDA approved. Among the capabilities that will be integrated with Alvotech’s operations are assembly and packaging of autoinjectors, pre-filled syringes and safety devices and packaging of vials. Ivers-Lee has an international customer base and will also continue servicing other existing clients and providing CMO services, including blister and stick-pack activities as well as clinical supplies and QP services, provided by the unit in Lörrach. About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Alvotech Forward-Looking StatementsCertain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to successfully integrate the operations of its subsidiaries with its core operations, including Ivers Lee; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONSBenedikt Stefansson, VPalvotech.ir@alvotech.com SWISS MEDIA CONTACTPeter Schüpbach, MD Ivers-Leep.schuepbach@iverslee.com

AcquisitionDrug ApprovalBiosimilar

29 Jun 2025

·www.globenewswire.com

Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)

June 25, 2025 — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic. The randomized, double-blind, multicenter study assessed the efficacy, safety, and immunogenicity of AVT23 compared to Xolair® in patients with Chronic Spontaneous Urticaria (CSU), who remained symptomatic despite treatment with H1 antihistamines. The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar candidate and the reference biologic. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks over a 24-week period. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients who received the confirmatory dose of 300 mg. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12 between the treatment groups of ADL-018 and reference product. “The positive results from this confirmatory patient study represent an important step in the development of the Xolair® biosimilar candidate. We look forward to working with our partners to increase global patient access to this important medicine,” said Joseph McClellan, Chief Scientific Officer of Alvotech. “This marks a positive advancement for Kashiv’s growing biosimilar pipeline in addition to its current portfolio of Releuko® and Fylnetra®. We look forward to collaborating with regulatory authorities to make this treatment available to patients,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, “We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Alvotech and Advanz Pharma.” “The successful confirmatory efficacy results for the proposed biosimilar to XOLAIR® mark an important milestone in Advanz Pharma’s ambition to expand patient access to specialty medicines across our core geographies, Europe, Canada, and Australia.” said Nick Warwick, Chief Medical Officer at Advanz Pharma. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has already validated and accepted the marketing authorization application (MAA) for AVT23 earlier this year, and the filing of an MAA with the European Medicines Agency (EMA) is expected before the end of the year. AVT23 is a proposed biosimilar to Xolair® (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair®, which contains omalizumab, is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy [1]. AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Alvotech partnered with Kashiv BioSciences for the development of the proposed Xolair® biosimilar, which is referred to as AVT23 by Alvotech and as ADL-018 by Kashiv Biosciences. Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalBiosimilarNDA

17 Jun 2025

·www.pharmaceutical-technology.com

Teva to collaborate with Fosun Pharma for TEV-56278

TEV-56278 has been specifically engineered to target PD-1 + T cells selectively. Credit: alicancomertpay/Shutterstock. Teva Pharmaceutical has announced a collaboration with Shanghai Fosun Pharmaceutical (Fosun Pharma) to advance the global development of the anti-programmed cell death protein 1 (PD1)-Interleukin-2 (IL2) ATTENUKINE therapy, TEV-56278. The collaboration will enhance clinical data generation for the potential treatment, which utilises Teva’s ATTENUKINE technology designed to offer efficacy with low toxicity across various oncology indications. Teva Global research and development (R&D) executive vice-president and chief medical officer Eric Hughes stated: “This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring the acceleration of our pipeline. “TEV-56278 demonstrates the strength of Teva’s innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients.” Fosun Pharma will have exclusive rights to develop, manufacture and commercialise the therapy in Mainland China, the Hong Kong Special Administrative Region (SAR), Macau SAR, the Taiwan region and selected countries in Southeast Asia. Teva retains all corresponding rights outside of these territories. The deal provides the company with insights from Fosun Pharma’s regional data that can be leveraged globally. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Fosun Pharma executive president and global R&D centre CEO Xingli WANG stated: “We are pleased to partner with Teva on the development of TEV-56278. “This collaboration brings together Teva’s expertise in innovative drug development with Fosun Pharma’s strong oncology development experience and commercial capabilities in the China market, creating a powerful synergy to accelerate the delivery of this important therapy to patients globally.” TEV-56278 has been specifically engineered to target PD-1 + T cells selectively. This targeted method could significantly improve patient outcomes across multiple oncology diseases. In February 2025, Teva and Alvotech have announced the US launch of the Selarsdi (ustekinumab-aekn) injection, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

License out/in

100 Deals associated with Ustekinumab biosimilar (Alvotech)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AC05	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ulcerative colitis, active moderate	United States	Alvotech USA, Inc.	18 Oct 2024
Ulcerative colitis, active severe	United States	Alvotech USA, Inc.	18 Oct 2024
Psoriasis	European Union	Alvotech	10 Jan 2024
Psoriasis	Iceland	Alvotech	10 Jan 2024
Psoriasis	Liechtenstein	Alvotech	10 Jan 2024
Psoriasis	Norway	Alvotech	10 Jan 2024
Crohn's disease, active moderate	European Union	STADA Arzneimittel AG	05 Jan 2024
Crohn's disease, active moderate	Iceland	STADA Arzneimittel AG	05 Jan 2024
Crohn's disease, active moderate	Liechtenstein	STADA Arzneimittel AG	05 Jan 2024
Crohn's disease, active moderate	Norway	STADA Arzneimittel AG	05 Jan 2024
Crohn's disease, active severe	European Union	STADA Arzneimittel AG	05 Jan 2024
Crohn's disease, active severe	Iceland	STADA Arzneimittel AG	05 Jan 2024
Crohn's disease, active severe	Liechtenstein	STADA Arzneimittel AG	05 Jan 2024
Crohn's disease, active severe	Norway	STADA Arzneimittel AG	05 Jan 2024
Crohn Disease	Canada	JAMP Pharma Corp.	01 Nov 2023
Arthritis, Psoriatic	Japan	Fuji Pharma Co., Ltd.	25 Sep 2023
Plaque psoriasis	Japan	Fuji Pharma Co., Ltd.	25 Sep 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04930042 (AVT04-GL-301, FDA_CDER) Manual	Phase 3	Arthritis, Psoriatic	927	Ustekinumab 45 mg (PsA STUDY 1)	mtbjajsozv(ggbewkenco) = hzhrcnwoxw tyefitkuca (pofesncspx ) View more	Positive	16 Apr 2024
				Ustekinumab90 mg (PsA STUDY 1)	mtbjajsozv(ggbewkenco) = ipqefobfrb tyefitkuca (pofesncspx ) View more
NCT04930042 (AVT04-GL-301, FDA_CDER) Manual	Phase 3	Plaque psoriasis	2,069	Placebo (Ps STUDY 1 + Adult)	jajbasygxf(asegbspvvd) = dchckblkvz rohmiybomi (tcoirnikpn ) View more	Positive	16 Apr 2024
				Ustekinumab 45 mg (Ps STUDY 1 + Adult)	jajbasygxf(asegbspvvd) = qntawjyqew rohmiybomi (tcoirnikpn ) View more
EADV2023	Not Applicable	Plaque psoriasis	581	AVT04	wwfjdlxruo(xufksswvin) = kixbxgmhhq iogsfodxte (afmytznihw )	Positive	11 Oct 2023
				Reference Product Ustekinumab	wwfjdlxruo(xufksswvin) = umbacozqml iogsfodxte (afmytznihw )
NCT04930042 (Pubmed \| Expert Opin Biol Ther)	Phase 3	Plaque psoriasis	581	AVT04	cgrtxnsytz(onmatzoaan) = gxkjwcydji gxukzmysdh (ecvixgaota )	Positive	12 Jul 2023
				Reference product ustekinumab (Stelara®)	cgrtxnsytz(onmatzoaan) = rqdxasnoxa gxukzmysdh (ecvixgaota )
NCT04930042 (AAD2023)	Phase 3	Psoriasis	581	AVT04	pejixuviqf(gupduupqwd) = btytesrkqc clooehywes (bjfvfdavfo ) View more	-	17 Mar 2023
				Reference Ustekinumab	pejixuviqf(gupduupqwd) = utlrwaaasc clooehywes (bjfvfdavfo ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

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.

view full example data

Regulation

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

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

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

Start your data trial now!

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