Alvotech and Advanz Pharma have submitted a European marketing application for its golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar expected to launch after Opdivo's patent expiry.
European Filing for Golimumab Biosimilar
Alvotech, a global biotech company specializing in biosimilars, and Advanz Pharma, a UK-headquartered pharmaceutical company, announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for AVT05, a proposed biosimilar to Simponi (golimumab).1
Simponi is a biologic used to treat various chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This marks the first global filing for a biosimilar candidate referencing Simponi, with the regulatory approval process expected to conclude in the fourth quarter of 2025.
The collaboration between Alvotech and Advanz Pharma extends beyond AVT05. The companies first partnered in February 2023 for AVT23, a proposed biosimilar to Xolair (omalizumab), and expanded their agreement in May 2024 to include 5 additional biosimilar candidates. These include AVT16, a proposed biosimilar to Entyvio (vedolizumab), and 3 early-stage biosimilar candidates yet to be disclosed.
Celltrion Secures Denosumab Korean Approval
Celltrion has achieved a significant milestone by obtaining approval for Stavoklone and Oseni Belt in the Republic of Korea, the first biosimilars approved in the country referencing Prolia and Xgeva (denosumab), respectively.2 Prolia is used to treat osteoporosis and Xgeva treats cancer-related bone metastasis. Approved by the Republic of Korea's Ministry of Food and Drug Safety, these biosimilars match the indications of their originator drugs, including osteoporosis treatment in postmenopausal women and prevention of skeletal complications from cancer-related bone metastases.
The approvals were based on global phase 3 clinical trial results, and Celltrion is now the first to launch biosimilars of Prolia and Xgeva in the Korean market. These originator drugs collectively generated $6.16 billion globally in 2023. Beyond the Republic of Korea, Celltrion has applied for regulatory approval in the US and Europe.
A company representative emphasized that these cost-effective treatments align with existing therapies in efficacy, with plans to secure global market approvals to strengthen their competitive position.
Xbrane, Intas to Collaborate on New Biosimilar
Intas Pharmaceuticals has secured exclusive global rights to develop and commercialize Xbrane Biopharma's nivolumab biosimilar candidate, referencing Opdivo, which achieved $9 billion in global sales in 2023.3
Under the partnership, Intas will finance and manage the clinical and regulatory development of the biosimilar, with commercialization handled by its subsidiary Accord Healthcare. Xbrane will receive an upfront payment of €10 million, milestone payments of €3 million, and double-digit royalties after the product’s launch. The nivolumab biosimilar is expected to launch in the US by December 2028 and in Europe by June 2030, aligning with Opdivo's patent expirations.
References
1. European Medicines Agency confirms acceptance of marketing authorization application for AVT05, a proposed biosimilar to Simponi® (golimumab). Press release. Alvotech; November 4, 2024. Acessed December 3, 2024. https://www.globenewswire.com/news-release/2024/11/04/2973885/0/en/European-Medicines-Agency-Confirms-Acceptance-of-Marketing-Authorization-Application-for-AVT05-a-Proposed-Biosimilar-to-Simponi-golimumab.html
2. Celltrion secures first approval for Prolia biosimilar in Korea. Press release. Celltrion; November 22, 2024. Accessed December 3, 2024. https://kormedi.com/1738990/
3. Xbrane and Intas enter into a global licensing agreement to jointly develop nivolumab biosimilar referencing Opdivo®. Press release. Xbrane Biopharma. November 19, 2024. Accessed December 3, 2024. https://xbrane.com/en/mfn_news/xbrane-and-intas-enter-into-a-global-licensing-agreement-to-jointly-develop-nivolumab-biosimilar-referencing-opdivo/