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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 ...

On 16 and 17 May 2024, respectively, the Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety approved MSD’s Keytruda® (pembrolizumab) for the following additional indications:

locally advanced cervical cancer; and
as an adjuvant a...

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®...

On 17 May 2024, Regeneron filed a second complaint against Celltrion in the US District Court for the Northern District of West Virginia asserting infringement of 25 US patents relating to aflibercept (including method of treatment, formulation and manufacturing claims).  R...

On 16 May 2024, the FDA granted accelerated approval to Amgen’s IMDELLTRATM (tarlatamab-dlle) for small cell lung cancer that has progressed on or after platinum-based chemotherapy.  Tarlatamab is a Bispecific T-cell Engager (BiTE®) molecule designed to engage a patient’s o...

On 15 May 2024, Formycon announced its partnership with MS Pharma in MENA for the commercialisation of its aflibercept biosimilar FYB203.  Klinge Pharma GmbH, which holds the global commercialisation rights for Formycon’s FYB203, granted MS Pharma exclusive rights to licens...