The patent for Janssen’s second-generation, tumour necrosis factor-alpha (TNF)-a inhibitor Simponi (golimumab), is scheduled to expire in 2024 and in 2025 in the US and EU, respectively. As patent expiration approaches, strategic activity within this space indicates that the landscape is shifting. In May 2023, Alvotech and Advanz Pharma announced an extended strategic partnership with plans to supply and commercialise five proposed biosimilars in Europe, including Simponi. Consequently, Alvotech’s AVT05 entered a Phase III RA study (NCT05842213). This global study positions AVT05 as the leading contender for Simponi biosimilars in the rheumatoid arthritis (RA) market, says GlobalData, a leading data and analytics company.

Momna Ali, Healthcare Analyst at GlobalData, comments: ‘’As Alvotech is the only company conducting a global study investigating a biosimilar for Simponi, this positions them strongly, potentially enabling them to monopolize Simponi’s market share upon patent expiry.’’

GlobalData’s latest report “Rheumatoid Arthritis: Global Drug Forecast and Market Analysis to 2029,” reveals that in the 8MM (US, 5EU, Japan, and Australia), the number of individuals affected by RA is projected to rise from 6,308,268 cases in 2019 to 6,980,823 cases by 2029, with an annual growth rate (AGR) of 1.07% during the forecast period.

Ali adds: “Despite the mature RA market, there is an unmet need, particularly concerning cost-effective therapies and earlier diagnosis. Although biosimilarity has not been established yet, the fact that AVT05 has progressed to Phase III alludes to a promising pipeline candidate.”

This development is also anticipated to be beneficial for Alvotech, as since its inception, it has incurred net losses each year and accumulated a deficit of $1,140.5 million as of December 31, 2021. However, Alvotech has been expanding its portfolio; currently, it has 11 biosimilar candidates in its pipeline for various diseases, of which five of them, AVT02, AVT03, AVT04, AVT05, and AVT16b fall under the therapy area of Immunology. Collectively, the product revenue for the first six months of 2023 increased to $22.7 million, as opposed to $3.9 million for the same period in 2022.

Ali concludes: “The anticipated approval and launch of AVT05 will potentially continue this upward trend for Alvotech.”