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Viatris and Biocon Biologics announced the US launch of Semglee® (interchangeable biosimilar insulin glargine) and Insulin Glargine.

Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:

Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
Janssen’s Darzalex SC® (da...

RegenXBio announced additional interim data from its Ph II trials of RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases). RGX-314 is a recombinant adeno-associated virus ...

The CHMP recommended approval of Celltrion’s Regkirona® regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Eu...

Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target action date in December 2021. Coherus also disclosed that the FDA has accepted the BLA for its proposed ...