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 Date02 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 Date24 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 Apr 2026·Dermatology and Therapy

AVT04, a Biosimilar to Reference Product Ustekinumab, for the Treatment of Plaque Psoriasis: Insights from a Real-World Experience up to 28 Weeks

Article

Author: Talamonti, Marina ; Tofani, Lorenzo ; Galluzzo, Marco ; Marrapodi, Domenico ; Gneo, Valerio ; Mortato, Edoardo ; Bianchi, Luca ; Marcelli, Lorenzo ; Savastano, Lorenzo ; Ingrosso, Maria Rosa

INTRODUCTION:

This study aims to evaluate the real-life efficacy and safety of a biosimilar to reference product (RP) ustekinumab for the treatment of plaque psoriasis in different patient scenarios. The cohort included ustekinumab-switched patients, who switched from the RP to the biosimilar, and ustekinumab-naïve patients, never treated with ustekinumab. Ustekinumab-naïve patients were subdivided into bio-naïve (no prior biologic therapy) and bio-experienced (previous non-ustekinumab biologic therapy).

METHODS:

Adult patients with chronic plaque psoriasis treated with AVT04 were followed up to 28 weeks. Efficacy of the biosimilar was assessed by improvement of the Psoriasis Area Severity Index (PASI) 75, 90, and 100 responses from baseline to weeks 16 and 28. A cost-minimisation analysis over a 1-year time horizon was performed to estimate costs and potential savings with AVT04 versus RP across the Italian National Health Service (NHS).

RESULTS:

Throughout the observation period, a sustained improvement in PASI was observed in the overall cohort of 183 patients, encompassing both the ustekinumab-switched and ustekinumab-naïve groups. Within the ustekinumab-naïve group, a trend toward more favourable PASI 75/90/100 responses was observed in bio-naïve patients compared to bio-experienced patients. By 28 weeks of treatment, a higher proportion of bio-naïve patients compared to the bio-experienced group achieved PASI 75 (72.7% vs. 56.2%), PASI 90 (72.7% vs. 50.0%), and PASI 100 (54.5% vs. 37.5%), respectively (p > 0.05). No adverse events were reported during the study. Furthermore, the cost-minimisation analysis suggested that compared to the RP, AVT04 has the potential to generate approximately €5200 in annual savings per patient for the Italian NHS, representing around €20 million in nationwide savings.

CONCLUSION:

AVT04 biosimilar shows consistent efficacy results in both ustekinumab-switching and ustekinumab-naïve patients, supporting its integration into real-world practice as an effective and cost-saving therapeutic option. Further studies are warranted to confirm and expand these preliminary findings across a broader bio-naïve cohort.

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: Berti, Fausto ; Otto, Hendrik ; 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.

142

News (Medical) associated with Ustekinumab biosimilar (Alvotech)

02 Jun 2026

·www.biospace.com

Alvotech to present at upcoming investor conferences in June 2026

REYKJAVIK, Iceland, June 02, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Alvotech's Founder and Executive Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in June as follows: Jefferies Global Healthcare Conference in New York – fireside chat on Thursday, June 4, 2026 at 9:20 am ET Goldman Sachs 47 th Annual Global Healthcare Conference in Miami – fireside chat Monday, June 8, 2026 at 8:40 am ET UBS Virtual Generics and Biosimilars Day – fireside chat on Wednesday, June 10, 2026 at 10:30 am ET The live audio webcasts will be available to investors and the general public and can be accessed in the Investors Section of Alvotech’s website under News and Events – Events and Presentations . After the event, a recording will also be available for up to 90 days. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology 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. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). 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. For more information, please visit . 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 .

01 Jun 2026

·investors.alvotech.com

Alvotech to present at upcoming investor conferences in June

REYKJAVIK, ICELAND (June 2, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Alvotech's Founder and Executive Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in June as follows: Jefferies Global Healthcare Conference in New York – fireside chat on Thursday, June 4, 2026 at 9:20 am ET (13:20 GMT) Goldman Sachs 47th Annual Global Healthcare Conference in Miami – fireside chat Monday, June 8, 2026 at 8:40 am ET (12:40 GMT) UBS Virtual Generics and Biosimilars Day – fireside chat on Wednesday, June 10, 2026 at 10:30 am ET (14:30 GMT) The live audio webcasts will be available to investors and the general public and can be accessed in the Investors Section of Alvotech’s website under News and Events – Events and Presentations. After the event, a recording will also be available for up to 90 days. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology 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. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). 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. 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.

Biosimilar

31 May 2026

·www.biospace.com

Alvotech and Islandsbanki renew Market Making Agreement for ALVO Shares Trading on Nasdaq Iceland

REYKJAVIK, ICELAND (June 1, 2026) — Alvotech (Nasdaq: ALVO) and Islandsbanki have renewed and amended their existing market making agreement. According to the agreement, Islandsbanki places bids and offers for ALVO shares trading on the Nasdaq Iceland Main Market (the “Exchange”) for a minimum amount with a fixed spread between the bid and offer price. The objective of the market-making agreement is to increase trade in Alvotech’s shares, liquidity and transparent price formation. As a market maker, Islandsbanki will post bid and ask quotes on the Exchange with an aggregate market value of at least ISK 8 million prior to the start of daily trading. Both the bid and ask quotes shall be refreshed as soon as possible but no later than 15 minutes after being executed in full. Islandsbanki aims to maintain more than one bid and/or ask quote for Alvotech’s shares such that the total market value of outstanding quotes is at least ISK 8 million at all times, but the bank is not obligated to maintain multiple bid or ask quotes. Islandsbanki also reserves the right to post additional bid and ask quotes even if existing quotes remain unexecuted. The maximum spread between bid and ask quotes is 2.5%, calculated as the volume weighted average of the bid and ask quotes for Alvotech’s shares posted by Islandsbanki as market maker at any given time. The daily net volume of trades by Islandsbanki as a market maker in Alvotech’s shares shall be limited to ISK 16 million. This amount is calculated as the difference between bids and asks by Islandsbanki that have been executed in full. When the maximum amount is reached, Islandsbanki is under no further obligation during that day to post either a bid or ask quote, depending on which side has been filled. Once a quote on the opposite side is executed and the daily net volume falls below the ISK 16 million mark, the market maker’s obligation to post bid and ask quotes is restored. The amended agreement was executed on May 29, 2026, and has no fixed term. Each party has the right to terminate the agreement by giving a 7-day prior notice. About Alvotech Alvotech is a biotechnology 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 biosimilars by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). 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. For more information, please visit . 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 INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS Benedikt Stefansson, VP alvotech.ir@alvotech.com

Biosimilar

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	UstekinumabUstekinumab 45 mg (PsA STUDY 1)	xuykqctxzz(mzkrlirwpj) = vkutanwzqd ofcwzjoimm (lurqxupims ) View more	Positive	16 Apr 2024
				Ustekinumab 90 mgUstekinumab90 mg (PsA STUDY 1)	xuykqctxzz(mzkrlirwpj) = dsxwmtlbcl ofcwzjoimm (lurqxupims ) View more
NCT04930042 (AVT04-GL-301, FDA_CDER) Manual	Phase 3	Plaque psoriasis	2,069	Placebo (Ps STUDY 1 + Adult)	drjsmgmyac(cwrkcpuxsa) = hfehdganzr vqgnqetobx (oylkgeylzy ) View more	Positive	16 Apr 2024
				Ustekinumab 45 mg (Ps STUDY 1 + Adult)	drjsmgmyac(cwrkcpuxsa) = tednmemile vqgnqetobx (oylkgeylzy ) View more
NCT04930042 (Pubmed \| Expert Opin Biol Ther)	Phase 3	Plaque psoriasis	581	AVT04	jodqgqfhsu(utimwwrapo) = nzrzmfxqoc htczqijtxh (dtoqziitav )	Positive	12 Jul 2023
				Reference product ustekinumab (Stelara®)	jodqgqfhsu(utimwwrapo) = jdiqobxakk htczqijtxh (dtoqziitav )
NCT04930042 (AAD2023)	Phase 3	Psoriasis	581	AVT04	bstfpdmiyc(tdiauzpjua) = xjvulbbmfi xzhnmppjav (bpwrhsdjgj ) View more	-	17 Mar 2023
				Reference Ustekinumab	bstfpdmiyc(tdiauzpjua) = jbzsnuvntd xzhnmppjav (bpwrhsdjgj ) 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