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.

News (Medical) associated with Ustekinumab biosimilar (Alvotech)

20 Mar 2025

·pipelinereview.com

Alvotech Acquires Xbrane’s R&D Operations in Sweden and Further Affirms its Global Leadership Position in Biosimilars Development and Production

REYKJAVIK, Iceland and STOCKHOLM, Sweden I March 20, 2025 I Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane’s R&D operations based in Campus Solna, at the Karolinska Institute outside Stockholm, Sweden, as well as the biosimilar candidate XB003, referencing Cimzia® (certolizumab pegol). Xbrane retains other pre-clinical assets and will focus on the commercialization of this portfolio. Alvotech also announced that it intends to explore the possibility of a listing of Swedish Depository Receipts (SDR), equity share equivalents, on Nasdaq Stockholm, in the future. The acquisition in brief “Alvotech has a best-in-class biosimilars manufacturing site in Iceland, both for drug substance and drug products. At the same time, our strong in-house R&D capabilities have put Alvotech in a leading position among pure play biosimilar companies in terms of the market value of our product pipeline. This acquisition will further expand Alvotech’s development capacity, allowing our commercial network of 19 leading commercial partners worldwide to continue increasing patient access to quality biologics,” said Robert Wessman, founder, Chairman and CEO of Alvotech. “Furthermore, we will establish a strong presence for Alvotech in the Swedish life science sector, which rivals the U.S. in this field. It will allow Alvotech to attract new talent, create opportunities for scientific collaboration, and support our growth. This is yet another milestone for Alvotech in establishing us as a leader in biosimilars development and production globally.” “With this transaction Xbrane is significantly strengthening its financial position and retains over 75% of the competitively adjusted addressable market of the portfolio including Ximluci (Lucentis biosimilar candidate) currently being approved and sold in Europe as well as Xdivane (Opdivo biosimilar candidate), recently partnered with Intas. Xbrane will, with a more lean and flexible organization after the transaction, be better equipped to fully focus on realizing the full value of Ximluci and Xdivane with the ambition to generate meaningful royalties/profit sharing from these programs in the years to come,” said Martin Åmark, CEO of Xbrane. Headquartered in Reykjavik, Iceland, Alvotech’s shares are listed on Nasdaq Iceland and Nasdaq US. 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. Since 2013, Alvotech has invested about $1.9 billion in a purpose-built biosimilars R&D and manufacturing platform, established commercial partnerships with 19 leading companies in over 90 of the largest global markets and developed one of the most valuable portfolios in the biosimilars industry. Advisors DNB Carnegie is acting as financial advisor to Alvotech in connection with the Acquisition. Cirio and Westerberg are legal advisors to Alvotech in connection with the Acquisition. About Alvotech 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. For more information, please visit our investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . SOURCE: Alvotech

AcquisitionDrug ApprovalBiosimilar

19 Mar 2025

·pipelinereview.com

Alvotech and Dr. Reddy’s Announce FDA Acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®

HYDERABAD, India & REYKJAVIK, Iceland I March 18, 2025 I Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”) and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab). “The FDA’s filing acceptance of Dr. Reddy’s proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan Kalawadia, Chief Executive Officer, Dr. Reddy’s North America. “This milestone marks an important step in our mission to improve patient lives by expanding access to affordable and quality biologic medicines. We look forward to being able to serve the large population of patients requiring treatment for osteoporosis and other diseases of the bone,” said Joseph McClellan, Chief Scientific Officer for Alvotech. Prolia® is a prescription biologic medicine used to treat osteoporosis in women after menopause who are at high risk for bone fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well [1]. Xgeva® is a prescription biologic medicine used to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors [2]. In May 2024, Dr. Reddy’s and Alvotech entered into a License and Supply Agreement for AVT03. Under the agreement, Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy’s is responsible for registration and commercialization in applicable markets, including the U.S. After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial. About AVT03 AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations. Prolia® is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture [1]. Xgeva® is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone [2]. AVT03 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. References Use of trademarks Prolia® and Xgeva® are registered trademarks of Amgen Inc. About Dr. Reddy’s Laboratories Ltd: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com . About Alvotech 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. For more information, please visit our investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram and YouTube . SOURCE: Alvotech

License out/inDrug Approval

25 Feb 2025

·endpts.com

J&J seeks to stop Samsung Bioepis from licensing Stelara biosimilar

Johnson & Johnson is suing Samsung Bioepis for allegedly breaching the terms of a contract regarding the launch of the Korean biotech’s Stelara biosimilar. The lawsuit , filed Monday in federal district court, claims that Samsung violated a settlement agreement between the two parties by trying to sublicense the rights to a Stelara biosimilar to a private label provider. The 2023 agreement had allowed Samsung to launch its biosimilar product Pyzchiva in February this year, but barred it from sublicensing biosimilars to third parties. The action comes amid a flurry of Stelara biosimilar launches starting in January that are set to erode sales of the medicine, which has been a top-seller for J&J since 2019. Amgen’s Stelara biosimilar Wezlana was the first to launch last month. Nuvaila — Optum Rx’s biosimilar business — is selling Wezlana under a private label . The biosimilar versions come with a wide variety of list prices , from 5% off the branded price to between 86% and 90% off. J&J secured FDA approval for Stelara for the treatment of psoriasis in 2009. It later won label expansions for psoriatic arthritis, ulcerative colitis and Crohn’s disease. The IL-12/IL-23 targeting monoclonal antibody reached $10.9 billion in sales at its peak in 2023. But key patents started expiring that same year, opening the door for cheaper versions. Samsung’s partner Sandoz announced the US launch of Pyzchiva on Monday. In a statement shared with the media on Tuesday, J&J said it is seeking an injunction against Samsung for trying to sublicense “a second, additional product” to a pharmacy benefit manager’s private label distributor. The drugmaker stressed it is not trying to stop Samsung from selling Pyzchiva. Samsung declined to comment on the ongoing litigation. Teva and Alvotech’s biosimilar Selarsdi was launched last week. On Monday, Biocon Biologics launched its biosimilar Yesintek. The FDA has approved a total of seven Stelara biosimilars so far. Editor’s Note: This article was updated to add more context on Amgen’s Wezlana.

Drug ApprovalPatent InfringementPatent ExpirationBiosimilarLicense out/in

100 Deals associated with Ustekinumab biosimilar (Alvotech)

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R&D Status

10 top approved records.

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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)	gzpquyazza(oeyematidv) = bcrtvhvvod ebpjbqksxy (zgrvscjxnv ) View more	Positive	16 Apr 2024
				Ustekinumab90 mg (PsA STUDY 1)	gzpquyazza(oeyematidv) = vbfbzdapzj ebpjbqksxy (zgrvscjxnv ) View more
NCT04930042 (AVT04-GL-301, FDA_CDER) Manual	Phase 3	Plaque psoriasis	2,069	Placebo (Ps STUDY 1 + Adult)	pzcoyazazq(xkjbqgjkhv) = dajdlqviwf oaljujfrnk (tidbpgnyus ) View more	Positive	16 Apr 2024
				Ustekinumab 45 mg (Ps STUDY 1 + Adult)	pzcoyazazq(xkjbqgjkhv) = tsreuztrny oaljujfrnk (tidbpgnyus ) View more
EADV2023	Not Applicable	Plaque psoriasis	581	AVT04	qthdbabenw(jdhzvgeydf) = cfkhktqdvy jhnqucvcha (wxtqravjpp )	Positive	11 Oct 2023
				Reference Product Ustekinumab	qthdbabenw(jdhzvgeydf) = ysjlwqavhf jhnqucvcha (wxtqravjpp )
NCT04930042 (Pubmed \| Expert Opin Biol Ther)	Phase 3	Plaque psoriasis	581	AVT04	wjyxaaerug(mupwstgxcr) = knngkmxeha zunizzqcrx (xptksekras )	Positive	12 Jul 2023
				Reference product ustekinumab (Stelara®)	wjyxaaerug(mupwstgxcr) = vejwejrauy zunizzqcrx (xptksekras )
NCT04930042 (AAD2023)	Phase 3	Psoriasis	581	AVT04	kosbldawer(pelyuiofrm) = dyszlkptwe llosehpvnp (osagawuoph ) View more	-	17 Mar 2023
				Reference Ustekinumab	kosbldawer(pelyuiofrm) = kszjezopbe llosehpvnp (osagawuoph ) View more

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