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Novartis announced that the FDA has approved its new intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

On 1 June 202...

Pfizer announced that the FDA has designated Abrilada® as the second interchangeable biosimilar to AbbVie’s Humira® (adalimumab), Following BI’s Cyltezo®.  The designation applies to all approved Abrilada® indications.  Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) was ...

Celltrion USA announced that large Medical Benefits Manager Ventegra, will add Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) to its formulary as a “preferred drug” by ‘the first part of October 2023’.

On 2 October 2023, Celltrion announced that it received FD...

Coherus BioSciences announced it has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) to the FDA, following a satisfactory resolution of inspection findings at a third-party filler.  The res...

Thermo Fisher Scientific announced that it has expanded its St Louis biologics manufacturing facility, adding up to four Thermo Scientific™ bioreactors, each of which can process up to 5,000 liters.

Coherus BioSciences announced it has reached a significant milestone as sales of Cimerli® (ranibizumab-eqrn), a biosimilar to Genentech’s Lucentis®, exceed 100,000 doses in the first year.  Cimerli® is the first and only FDA-approved interchangeable biosimilar to Lucentis® ...

Novartis announced it successfully completed the spin-off of Sandoz, its former generics and biosimilars business on 4 October 2023.  Sandoz also made its own announcement about the spin-off, noting it completed its first trading day on the Swiss Exchange on 4 October with ...

A PLOS One study found that there was no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar. The study examined unique studies and switch treatment periods for each reference...