Alvotech and Advanz Pharma Achieve Milestone with Gobivaz®
In a significant advancement in biotechnology, Alvotech, a global leader in biosimilar medicines, announced its recent success alongside Advanz Pharma in receiving marketing authorisations for Gobivaz®, its biosimilar to Simponi® (golimumab). This important development, endorsed by the UK Medicines and Healthcare products Regulatory Agency (MHRA), paves the way for enhancing patient access to critical treatments for various immune-mediated diseases.
What is Gobivaz®?
Gobivaz® is designed to mimic the effects of Simponi®, a well-established treatment for conditions such as rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, and ulcerative colitis. Alvotech has developed this biosimilar to include formulations available in both 50 mg/0.5 mL and 100 mg/mL through pre-filled syringes and autoinjectors, making the delivery of treatment across the United Kingdom more convenient for patients.
Statement from Alvotech
Joseph McClellan, Chief Scientific and Technical Officer at Alvotech, expressed pride in achieving this hallmark approval. He stated, "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." This reflects the company's commitment to expanding treatment options and accessibility in the pharmaceutical landscape.
Advanz Pharma's Commitment
Advanz Pharma, on the other hand, fully supports this initiative. Nick Warwick, Chief Medical Officer at Advanz Pharma, mentioned, "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." Advanz Pharma aims to provide specialized medicines that improve patient care and health outcomes.
The European Perspective
In addition to the approvals by the MHRA, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has also issued a positive opinion that recommends Gobivaz® for approval across the European Economic Area. This approval is indicative of the growing recognition and validation of biosimilars in the treatment of chronic diseases.
Partnership Dynamics
The collaboration between Alvotech and Advanz Pharma is structured so that Alvotech manages the development and commercial supply of Gobivaz®, while Advanz Pharma retains the registration and exclusive commercialization rights in the UK and Europe. This partnership allows both companies to leverage their strengths to optimize the reach and effectiveness of their product offerings.
About Alvotech
Founded by Robert Wessman, Alvotech focuses on developing and manufacturing biosimilar medicines with the goal of becoming a key player in the global biosimilar market. The company emphasizes high-quality, cost-effective products, supported by a robust pipeline including eight disclosed biosimilar candidates aimed at treating a variety of diseases. Alvotech also engages in strategic commercial partnerships worldwide, which enhances their global presence and ability to respond to local regulatory environments.
About Advanz Pharma
Advanz Pharma, headquartered in London, UK, is dedicated to improving the lives of patients through a strong focus on specialty and rare disease medicines. The company operates in over 90 countries and is committed to fostering collaborations with biopharma and developmental organizations to ensure the effective distribution of essential medications. Advanz Pharma's portfolio includes an array of innovative solutions across multiple therapeutic areas, emphasizing their role as a key partner in the pharmaceutical industry.
Frequently Asked Questions
What is Gobivaz®?
Gobivaz® is a biosimilar to Simponi® (golimumab), used for treating various autoimmune conditions.
Who are the partners for Gobivaz®?
Alvotech and Advanz Pharma collaborate for the development and commercialization of Gobivaz®.
What has the MHRA authorized?
The MHRA has granted marketing authorisations for Gobivaz® to be used in treating several immune-mediated diseases.
Where can Gobivaz® be accessed?
Gobivaz® will be available in the UK, enhancing access for healthcare professionals and patients.
What markets does Alvotech operate in?
Alvotech operates globally, with strategic partnerships that span across the United States, Europe, Asia, and South America.
