Alvotech and Advanz Pharma announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval for Gobivaz, Alvotech's proposed biosimilar to Simponi, a biologic used to treat several chronic inflammatory diseases.
Regulatory Status and Partnership Structure
Gobivaz remains under EMA regulatory review with a final decision by the European Commission pending. The positive CHMP opinion represents a critical step in the European approval process for the biosimilar candidate.
Under the partnership agreement, Alvotech is responsible for the development and commercial supply of Gobivaz, while Advanz Pharma is responsible for registration and has exclusive rights for commercialization in Europe.
Reference Product and Market Context
Simponi and Simponi Aria are registered trademarks of Johnson & Johnson. The reference product is used to treat several chronic inflammatory diseases, representing a significant therapeutic area for biosimilar development.
Company Backgrounds
Alvotech is a biotech company founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. The company 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. The company 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.
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. The company has commercial sales in more than 90 countries globally and has a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia.
Next Steps
The final regulatory decision by the European Commission is awaited following the positive CHMP recommendation. This approval would enable Advanz Pharma to proceed with commercialization plans across European markets where it holds exclusive rights.
