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On 21 May 2024, Alvotech and Dr Reddy’s announced that that they have entered into a licence and supply agreement for the commercialisation of AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in the US, EU and UK.

Under the agreement, Alvotech will develop...

As previously reported, in the context of the ongoing US aflibercept litigation, Regeneron previously filed motions for preliminary injunctions against each of Celltrion, Formycon and Samsung Bioepis.  On 21 May 2024, Regeneron withdrew its preliminary injunction motions in...

On 21 May 2024, Johnson & Johnson announced results of the GALAXI 2&3 clinical studies of patients with moderate to severe Crohn’s Disease (CD).  The study, sponsored by Janssen Research & Development, showed that Tremfya® (guselkumab) resulted in significant im...

On 21 May 2024, Celltrion announced positive two-year results from its extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) for Zymfentra™ (infliximab-dyyb) in adults with moderately to severely active Crohn’s disease and ulcerative colitis after induction with intrav...

On 20 May 2024, Samsung Bioepis and Biocon won the race to be the first FDA approved interchangeable biosimilars to Regeneron’s Eylea® (aflibercept). Both Samsung Bioepis’ Opuviz (aflibercept-yszy) and Biocon’s YesafiliTM (aflibercept-jbvf) are approved for nAMD, macular ed...

On 20 May 2024, Teva and Alvotech announced that their interchangeable high concentration citrate-free adalimumab biosimilar Simlandi® (adalimumab-ryvk, AVT02) is now available in the US.  Simlandi® is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psori...

On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC).  The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients receiv...

On 20 May 2024, Regeneron and Sanofi announced the results of the NOTUS Phase 3 trial for use of  Dupixent® (dupilumab) as a maintenance treatment in adults with uncontrolled COPD and type 2 inflammation. The results were published in the New England Journal of Medicine on ...