European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)

Rhea-AI Summary

Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept). The approval process is expected to be completed by Q3 2025. This development marks a significant step towards making AVT06 available in Europe, potentially benefiting patients and caregivers.

Alvotech is responsible for AVT06's development and commercial supply, while Advanz Pharma holds exclusive commercialization rights in Europe, except for France and Germany. In 2023, Eylea® sales in Europe reached $2.9 billion, with global sales totaling $5.9 billion. Alvotech recently reported positive top-line results from a confirmatory clinical study comparing AVT06 with Eylea in patients with neovascular (wet) AMD, demonstrating therapeutic equivalence and comparable safety.

Positive

• EMA acceptance of Marketing Authorization Application for AVT06, a proposed biosimilar to Eylea®
• Potential market entry in Europe by Q3 2025
• Positive top-line results from confirmatory clinical study showing therapeutic equivalence to Eylea®
• Large market opportunity: Eylea® sales in Europe reached $2.9 billion in 2023

Negative

• None.

Biotech Analyst

The EMA's acceptance of AVT06's marketing application marks a significant milestone for Alvotech and Advanz Pharma. This biosimilar to Eylea® (aflibercept) could potentially disrupt the $2.9 billion European market for this important eye disorder treatment. With the approvals process expected to conclude by Q3 2025, investors should closely monitor the progress.

The positive results from the confirmatory clinical study, demonstrating therapeutic equivalence and comparable safety to Eylea®, strengthen AVT06's market potential. This development, coupled with Alvotech's pipeline including AVT29 (high-dose biosimilar), positions the company as a strong contender in the ophthalmology biosimilars space. The partnership with Advanz Pharma for European commercialization could accelerate market penetration upon approval.

Financial Analyst

The potential market entry of AVT06 in Europe by late 2025 could significantly impact the revenue streams of Eylea®'s manufacturer. With Eylea® generating $2.9 billion in European sales in 2023, even a modest market share capture by AVT06 could translate to substantial revenue for Alvotech and Advanz Pharma. Investors should note that biosimilars typically enter the market at a 15-30% discount, potentially driving rapid adoption.

Alvotech's end-to-end biosimilars platform demonstrates scalability and efficiency in developing multiple candidates, which could lead to improved profit margins and a competitive edge in the burgeoning biosimilars market. The strategic partnerships for commercialization in key European markets may help optimize market penetration and revenue potential upon approval.

Healthcare Policy Expert

The potential introduction of AVT06 in the European market aligns with the broader healthcare policy trend of promoting biosimilars to reduce healthcare costs. As governments and payers seek to manage rising healthcare expenditures, biosimilars like AVT06 could play a important role in expanding access to critical treatments for conditions like wet AMD, macular edema and diabetic retinopathy.

The successful development and potential approval of AVT06 could set a precedent for future ophthalmology biosimilars, potentially accelerating the development and approval processes for similar products. This could lead to a more competitive and cost-effective market for biologic eye treatments, benefiting both healthcare systems and patients across Europe. Investors should consider the long-term implications of this shift in the ophthalmology treatment landscape.

• The approvals process is anticipated to be completed in the third quarter of 2025
  

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and 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 European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept). The process to obtain marketing authorization could be completed in the third quarter of 2025.

"EMA acceptance takes us a step closer to making AVT06 available in Europe, which is good news for patients and caregivers," said Joseph McClellan, Chief Scientific Officer of Alvotech. "The successful development of multiple biosimilar candidates, demonstrates how Alvotech leverages its end-to-end biosimilars platform in support of broader access to affordable biologic medicines."

Dr. Nick Warwick, Chief Medical Officer for Advanz Pharma, said “This milestone is an important step towards providing patients with more treatment options and further strengthens Advanz Pharma’s commitment to expand access to specialty, hospital, and rare disease medicines across Europe.”

Alvotech is responsible for development and commercial supply of AVT06. Advanz Pharma is responsible for registration and has exclusive commercialization rights in Europe, except for France and Germany where the rights are semi-exclusive. French pharmaceutical company Biogaran holds semi-exclusive registration and commercialization rights for France. Alvotech is also developing AVT29, a biosimilar candidate for Eylea® high dose (8 mg). Advanz Pharma and Biogaran will also commercialize AVT29, for the same countries as AVT06.

Eylea® is a widely used biologic for the treatment of eye disorders, including diseases which can lead to vision loss or blindness, such as wet Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. In 2023, reported sales of Eylea® in Europe were $2.9 billion and cumulative global sales were $5.9 billion [1].

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between Alvotech’s biosimilar candidate and Eylea.

About AVT06/AVT29 (aflibercept)
AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) 2 mg and 8 mg dose, which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06/AVT29 are investigational products and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

Sources
[1] Regeneron Full Year 2023 Earnings Press Release
[2] Eylea product information

Use of trademarks
Elyea is a registered trademark of Regeneron Pharmaceuticals Inc. and Bayer AG.

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 has launched two biosimilars. 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 www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

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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, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, 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
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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 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 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.

CONTACTS

ALVOTECH
Benedikt Stefansson, VP Investor Relations and Global Communications
alvotech.ir@alvotech.com

ADVANZ PHARMA
Courtney Baines
Tel: +44 7776 516979
courtney.baines@advanzpharma.com

FAQ

What is the current status of Alvotech's AVT06 biosimilar for Eylea® in Europe?

The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application for AVT06, a proposed biosimilar to Eylea® (aflibercept). The approval process is expected to be completed by the third quarter of 2025.

What were Eylea®'s sales figures in Europe and globally for 2023?

In 2023, Eylea® sales in Europe were reported at $2.9 billion, while cumulative global sales reached $5.9 billion.

What were the results of Alvotech's clinical study for AVT06 (ALVO)?

Alvotech reported positive top-line results from a confirmatory clinical study comparing AVT06 with Eylea® in patients with neovascular (wet) AMD. The study met its primary endpoint, demonstrating therapeutic equivalence and comparable safety, including immunogenicity.

Who will be responsible for commercializing AVT06 in Europe?

Advanz Pharma holds exclusive commercialization rights for AVT06 in Europe, except for France and Germany where the rights are semi-exclusive. Biogaran holds semi-exclusive rights for France.