Sandoz passed a major milestone in 2024, with the firm’s sales for the first time exceeding $10bn on the back of a significant rise in biosimilars turnover. The company is continuing to push ahead with restructuring initiatives and also addressed the potential threat of US tariffs as management discussed the firm’s annual results.
Amgen has confirmed to Generics Bulletin details of its launch of Bkemv, the first US biosimilar to Soliris.
Ahead of the first biosimilars to denosumab emerging later in the spring, the market is continuing to prove enticing, with Amneal the latest to file for biosimilars to Prolia and Xgeva.
After a successful 2024, Hikma has announced plans to ramp up spending on R&D as part of its ongoing turn towards more complex compounds.
CEO says firm’s “three clear imperatives” to drive cash and “total shareholder return” comprise its “three S” plan. Perrigo’s net sales for the quarter down 1.6% to $1.14bn and for the year down 6.1% to $4.37bn.
Celltrion has become the third firm to win FDA approval for US biosimilar rivals to Prolia and Xgeva. But with multiple denosumab competitors set to launch in just a couple of months, and several more candidates on the way, the market looks likely to be another competitive one for biosimilar sponsors.
Fresenius has become the latest firm to launch a Stelara biosimilar in both the US and Europe, bringing partner Formycon’s Otulfi version to market. But with heavy discounting already seen in the US and multiple competitors already established in the EU, will the firm be able to stand out from the crowd?
Viatris is beginning to deliver on at least one of its complex generic injectables – long-promised by the US company as part of a deep and differentiated pipeline – as it pledged to provide further details at the firm’s upcoming company investor day.
Formycon has celebrated receiving a UK approval for its Ahzantive biosimilar version of Eylea, setting up a launch from partner Teva – which has already seen success in the UK market with the partners’ Lucentis biosimilar, Ongavia.
Biocon has announced the UK launch of its liraglutide generic rivals to Victoza and Saxenda, hailing a “significant milestone” for the firm’s GLP-1 business, which it expects to be a major growth driver in years to come.
Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm’s failure to have its generic version of Revlimid exempt from the restrictions.
Reporting year-end financials, the Fresenius group spoke at length about its ambition for Fresenius Kabi to reach the billion euro milestone in annual revenues for its prospering Biopharma unit in the coming years, as management also addressed queries about the dynamic pricing environment ahead of the firm’s imminent launch of a biosimilar to Stelara in the US.
South Africa’s Adcock Ingram struck a downbeat tone during its financial first-half results call, as multiple factors conspired to produce a performance “well below expectations.”
Select Indian drug manufacturers have missed some analyst estimates while Japanese firms continue in their efforts to leave the country’s generic drug supply crisis in the past.
The same day as Samsung Bioepis and Sandoz launched their partnered Pyzchiva biosimilar rival to Stelara in the US, originator J&J hit the Korean developer with a lawsuit claiming that a private-label commercialization deal with a US pharmacy benefit manager violates the ustekinumab settlement that allowed the firms to launch.
The UK’s NHS and Sandoz have both told Generics Bulletin that they are looking into reports from a single UK hospital of adverse reactions linked to patients that have switched from Tysabri to Sandoz’s Tyruko biosimilar.
With sales remaining sluggish, on the back of fewer launches, Glenmark’s management nevertheless struck an upbeat tone when discussing the firm’s prospects in the US moving into the company’s 2026 financial year.
As more Stelara biosimilars pile into the US market – including launches from Alvotech/Teva, Samsung Bioepis/Sandoz and Biocon Biologics – the latest data suggests that price competition for ustekinumab rivals could be fierce, with all three companies confirming to Generics Bulletin details of significant discounts to the brand.
Reformulation specialist Lipella has an eye on numerous milestones for its proposed oral rinse liposomal formulation of tacrolimus, including the submission of a Phase IIb clinical trial investigational new drug application.
Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.