Alvotech and Advanz Pharma Receive Marketing Authorisations for Gobivaz®, a Biosimilar to Simponi® (golimumab), from the MHRA

Rhea-AI Summary

Alvotech (NASDAQ: ALVO) and Advanz Pharma announced on November 6, 2025 that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisations for all four presentations of Gobivaz, a biosimilar to Simponi (golimumab).

The authorisations cover 50 mg/0.5 mL and 100 mg/mL formats in both pre-filled syringe and autoinjector forms for rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis (adults), and juvenile idiopathic arthritis across the United Kingdom. The EMA CHMP has issued a positive opinion recommending approval across the European Economic Area.

Under the partnership, Alvotech is responsible for development and commercial supply, while Advanz Pharma holds registration and exclusive commercialisation rights in Europe and the UK.

Positive

• MHRA approval granted for all four Gobivaz presentations in the UK
• CHMP positive opinion recommending EEA approval
• Four presentations cleared: 50 mg/0.5 mL and 100 mg/mL in syringe and autoinjector
• Wide indications covered including rheumatoid arthritis and ulcerative colitis
• Clear commercial roles: Alvotech supplies; Advanz holds EU/UK commercial rights

Negative

• EMA decision pending: CHMP issued a positive opinion but final EMA approval is not yet documented

Insights

Regulatory & Commercial Strategy Analyst

MHRA marketing authorisations for Gobivaz® in all four presentations and a CHMP positive opinion materially advance UK and EEA commercial rollout.

Alvotech received UK marketing authorisations from the MHRA for all four presentations of Gobivaz® (50 mg/0.5 mL and 100 mg/mL in pre-filled syringe and autoinjector). The approvals cover indications including rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis, and apply across the United Kingdom. The EMA CHMP has also issued a positive opinion recommending approval across the EEA, and the partnership assigns development and supply to Alvotech and registration and exclusive commercialisation rights in Europe and the UK to Advanz Pharma.

This clears a major regulatory barrier and enables legal commercial supply and prescribing in the UK immediately, while the CHMP positive opinion supports near-term EEA filings and national approvals. Key dependencies include successful national reimbursement and formulary inclusion decisions, commercial launch execution by the partner with the approved presentations, and timely EEA member‑state approvals following the CHMP opinion. The approval explicitly covers the four formats and the listed immune‑mediated disease indications.

Watch for three concrete near-term items: the timing of national reimbursement and pricing decisions across the UK and EEA; formal marketing authorisations from EEA member states following the CHMP positive opinion; and initial launch volume and tender outcomes once the product becomes available (expect activity over the next several months to Q2 2026 as countries complete reimbursement). These milestones will determine how quickly regulatory clearance converts into measurable commercial uptake.

11/06/2025 - 09:00 AM

REYKJAVIK, ICELAND and LONDON, UK (November 06, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations for all four presentations of Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab).

The authorisations cover Gobivaz® 50 mg/0.5 mL and 100 mg/mL presentations in both pre-filled syringe and autoinjector formats, for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis. The approvals apply across the United Kingdom.

”This approval further validates the strength and capabilities of Alvotech’s integrated development and manufacturing platform for biosimilars. We look forward to increasing access to an important biologic for the treatment of various immune-mediated diseases by making Gobivaz® available to patients in collaboration with our partner Advanz Pharma,” said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech.

“With these approvals, we are now well positioned to make Gobivaz® available to patients and healthcare professionals in the UK, helping to broaden access to an important biologic treatment for immune-mediated diseases,” said Nick Warwick, Chief Medical Officer at Advanz Pharma.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Gobivaz® across the European Economic Area.

Under the partnership between Alvotech and Advanz Pharma, Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds the registration and exclusive commercialisation rights in Europe and the UK.

About AVT05
AVT05 is a biosimilar candidate for Simponi® (golimumab) and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1]. 

Sources
[1] Gobivaz product information

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 includes eight 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), 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.

About Advanz Pharma
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.

Alvotech 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 or operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, 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 review and interactions, the satisfactory responses to the FDA’s inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech’s manufacturing site, the potential approval, including for AVT02, AVT04, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech’s pipeline products. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” 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 reach development milestones under commercial partnership agreements including the partnership with Advanz; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners, including Advanz, to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) 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; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz; (15) Alvotech’s ability, and that of its commercial partners, including Advanz, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, on Alvotech’s business, financial position, strategy and anticipated milestones; and (20) 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.

Advanz Pharma Forward Looking Statements
Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, "expectation", "belief', "estimate", "plan", "target”, “project”, “will”, “may”, “should” or "forecast" and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma’s markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice.

MEDIA CONTACTS

Alvotech Global Communications and Investor Relations
Benedikt Stefansson
alvotech.ir@alvotech.com

Advanz Pharma Global Corporate Communications
Courtney Baines
courtney.baines@advanzpharma.com

FAQ

What did Alvotech (ALVO) and Advanz Pharma announce on November 6, 2025?

They announced MHRA marketing authorisations for all four presentations of Gobivaz, a golimumab biosimilar, for use across the UK.

Which Gobivaz presentations received UK authorisation for ALVO?

Both 50 mg/0.5 mL and 100 mg/mL presentations in pre-filled syringe and autoinjector formats were authorised.

What indications does the MHRA authorisation for Gobivaz cover?

Authorisations cover rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis.

Has Gobivaz received approval for the European Economic Area for ALVO?

The EMA CHMP issued a positive opinion recommending approval across the EEA; final EMA decision is pending.

Who will commercialise Gobivaz in Europe and the UK under the ALVO partnership?

Under the partnership, Advanz Pharma holds registration and exclusive commercialisation rights in Europe and the UK; Alvotech provides development and supply.

Does the MHRA authorisation for Gobivaz apply across the entire UK for ALVO?

Yes. The authorisations explicitly apply across the United Kingdom.