Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi® (golimumab)
- Alvotech announced positive topline results from a confirmatory clinical study for AVT05, a biosimilar candidate to Simponi® (golimumab) for rheumatoid arthritis patients.
- The study showed therapeutic equivalence between AVT05 and Simponi, with no significant safety differences observed.
- Alvotech plans to file marketing applications for AVT05 in major global markets, emphasizing their expertise in biosimilar development.
- Global revenues from Simponi and Simponi Aria sales were around $3.2 billion in 2023.
- None.
Insights
Alvotech's announcement of successful primary endpoint attainment for their biosimilar AVT05 is a positive stride towards offering a therapy that mirrors Simponi, a well-established treatment for rheumatoid arthritis. The achievement of therapeutic equivalence in disease activity score (DAS28-CRP) not only promises to introduce a cost-effective alternative but also widens treatment access. From a financial perspective, a slice of Simponi's $3.2 billion revenue pie could significantly boost Alvotech's market share and attract investor attention due to the potential reduction in treatment costs and the competitive pricing strategies biosimilars generally employ.
Moreover, the absence of clinically meaningful safety differences through week 24 aligns with the critical regulatory benchmarks for biosimilar approval, smoothening the pathway for regulatory filings. The previous pharmacokinetic study underscores AVT05's consistent performance with its reference product, further bolstering the confidence in its clinical profile. Should Alvotech navigate the regulatory landscape successfully, the market can expect a forthcoming shift in the rheumatoid arthritis treatment domain, with potential implications for stakeholders across the healthcare value chain.
Biosimilars like AVT05 play a transformative role in biologics-driven markets by introducing price competition and innovation pressure. The global biologics market is forecasted to grow steadily and biosimilars are central to this narrative. For investors, Alvotech’s progression in its biosimilar pipeline heralds an expansion of its portfolio in a high-demand therapeutic area.
Strategically, Alvotech's plan to file marketing applications in major global markets indicates an aggressive entry strategy. Their first-mover advantage in announcing positive topline results could translate into a faster capture of market share, particularly in price-sensitive markets. Investors should monitor subsequent market entries and adoption rates, as they will be important indicators of Alvotech’s potential to disrupt existing market dynamics and carve out a niche in the biologics segment.
Pending the successful navigation of biologics' complex regulatory environment, Alvotech's biosimilar candidate could reshape market expectations for regulatory approvals. The company's swift progress from pharmacokinetic studies to patient studies demonstrates an adeptness in clinical trial management that might appeal to investors with interest in robust R&D pipelines.
While intellectual property battles often accompany biosimilar entries, Alvotech's clear communication and transparency in clinical developments could mitigate investor concerns over potential legal hurdles. Close attention should be paid to the company's interactions with regulatory bodies, as these will serve as precursors to the market's reception of AVT05 and its subsequent influence on Alvotech's stock performance.
- The confirmatory clinical safety and efficacy study for AVT05, biosimilar candidate to Simponi® and Simponi Aria® (golimumab), met its primary endpoint in patients with moderate to severe rheumatoid arthritis
- Alvotech is the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi or Simponi Aria
REYKJAVIK, Iceland, April 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab). Alvotech is the first company to announce positive topline results of a clinical trial using a proposed biosimilar to Simponi and Simponi Aria and is one of only two companies known to have initiated such a patient study.
“We are delighted at passing yet another clinical milestone in our pipeline,” said Robert Wessman, Chairman and CEO of Alvotech. “We intend to file marketing applications for AVT05 in major global markets this year, which adds to the continued diversification of our portfolio and further demonstrates the capabilities of our biosimilar-dedicated platform.”
Worldwide revenues in 2023 from sales of Simponi and Simponi Aria were approximately
The AVT05-GL-C01 confirmatory clinical study (NCT05842213) is a randomized, double-blind, 2-arm, multicenter confirmatory clinical study to investigate the efficacy, safety, and immunogenicity between subcutaneous AVT05 and EU Simponi in patients with moderate to severe rheumatoid arthritis. The primary outcome measure is change from baseline to week 16 in DAS28-CRP, which is a disease activity score measurement for rheumatoid arthritis. The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT05 and Simponi. Additionally, no clinically meaningful differences in safety were observed through week 24.
In November 2023 Alvotech announced positive topline results from a pharmacokinetic study (NCT05632211) for AVT05, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to EU approved Simponi and US-licensed Simponi in 336 healthy adult subjects. All three study treatments were given at a single dose of 50 mg/0.5 mL pre-filled syringe, via a subcutaneous injection. The study met its primary endpoints.
About AVT05
AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [2]. AVT05 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.
Sources
[1] Data from Evaluate Pharma.
[2] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf
Use of trademarks
Simponi® and Simponi Aria® are registered trademarks of Johnson & Johnson.
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. Alvotech’s current pipeline contains eight 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), 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 www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
Forward Looking Statements
Certain 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. 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Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (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. 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ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, Senior Director
alvotech.ir@alvotech.com
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FAQ
What are the topline results announced by Alvotech for AVT05?
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