Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.

Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.

Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.

After getting off to a slow start last year, US biosimilar rivals to Humira are beginning to gain more traction. Sandoz is increasing its share on a weekly basis, Alvotech and Teva have struck a deal for their newly-approved interchangeable 100mg/ml biosimilar, and the latest market data shows biosimilars capturing twice as much of the market in Q1 as in Q4 2023.

Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.

Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.