Alvotech Moves Forward with Gobivaz® Approval in Europe
Alvotech and Advanz Pharma Collaborate for Biosimilar Approval
REYKJAVIK and LONDON – Alvotech (NASDAQ: ALVO), a renowned biotechnology firm, along with Advanz Pharma, a leading global pharmaceutical company, has shared important news regarding the marketing approval of Gobivaz®, a proposed biosimilar to Simponi® (golimumab). This biologic treatment is designed for patients with various chronic inflammatory diseases.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has taken a significant step by endorsing a positive opinion for Gobivaz®. This recommendation signifies a promising advancement in providing patients with more treatment options for immune-mediated diseases.
Working Together for Patient Access
Joseph McClellan, Chief Scientific and Technical Officer for Alvotech, expressed optimism about the collaboration with Advanz Pharma. He noted, "The reference biologic Simponi® is pivotal for treating several immune-mediated diseases, and we aim to enhance accessibility for patients and healthcare professionals. This collaboration will be key in achieving that goal."
Advanz Pharma's Chief Medical Officer, Nick Warwick, also commented on the milestone, highlighting the importance of this positive CHMP recommendation in expanding patient access. The company aims to establish a strong biosimilars presence throughout Europe.
Details on Gobivaz®
The CHMP's opinion recommends granting a marketing authorization for Gobivaz® in several formats, including 50 mg/0.5mL and 100mg/mL in pre-filled syringes and autoinjectors. These treatments will cater to adult patients suffering from rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, as well as juvenile idiopathic arthritis. This authorization will extend across the 27 member states of the European Union, along with Norway, Iceland, and Lichtenstein.
Currently, Gobivaz® is under EMA regulatory review, and a final decision from the European Commission is still awaited.
Alvotech's Role in Development
Alvotech holds the responsibility for the development and commercial supply of Gobivaz®, while Advanz Pharma will handle registration and has the exclusive rights for its commercialization in Europe. This division of responsibilities reflects both companies' commitment to advancing healthcare solutions.
In April 2024, Alvotech disclosed encouraging top-line results from a clinical study that compared the efficacy, safety, and immunogenicity of its biosimilar candidate AVT05 against Simponi® in patients with moderate to severe rheumatoid arthritis. Additionally, in November 2023, positive results were announced from a pharmacokinetic study assessing AVT05 compared to Simponi® in healthy adult participants.
Understanding AVT05
AVT05 represents a promising biosimilar candidate for both Simponi® (golimumab) and Simponi Aria®. Golimumab acts as a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha), a vital factor implicated in several chronic inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis. However, it is important to note that AVT05 is still an investigational product that hasn't secured regulatory approval in any country. Therefore, biosimilarity has not yet been established by regulatory authorities.
About Alvotech
Founded by Robert Wessman, Alvotech is dedicated to developing and manufacturing biosimilar medicines designed to help patients globally. The company aims to lead the biosimilar market through high-quality, cost-effective products and services. Alvotech's current development pipeline includes eight disclosed biosimilar candidates targeting various conditions, including autoimmune disorders and certain cancers. It has forged a network of strategic partnerships to enhance its market reach and operational expertise across multiple regions, including North America, Europe, and parts of Asia and South America.
About Advanz Pharma
Advanz Pharma, headquartered in London, UK, is dedicated to enhancing patients’ lives by delivering specialty, hospital, and rare disease medications. With a commercial presence in over 90 countries, they operate in more than 20 countries, focusing on expanding their portfolio of innovative medicines and biosimilars across various therapeutic areas including oncology, gastroenterology, and critical care.
Frequently Asked Questions
What is Gobivaz®?
Gobivaz® is a biosimilar to Simponi® (golimumab), which is used to treat chronic inflammatory diseases such as rheumatoid arthritis.
What is the significance of the positive CHMP opinion?
The positive CHMP opinion is a pivotal step toward marketing approval in Europe, enhancing patient access to treatments.
Who is responsible for the commercialization of Gobivaz®?
Advanz Pharma has exclusive rights for the commercialization of Gobivaz® in Europe, while Alvotech manages its development and supply.
How does AVT05 relate to Gobivaz®?
AVT05 is the investigational biosimilar candidate that underpins Gobivaz®, subject to ongoing regulatory assessment.
What diseases does Gobivaz® aim to treat?
Gobivaz® is aimed at treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis.
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