Read our latest updates & insights

Samsung Bioepis launched a new white paper entitled ‘Improving the Understanding and Acceptance of Biosimilars in the United States’. In particular, the paper discusses the need to reduce information gaps, incentivise different stakeholders and practical considerations for ...

Pharmac announced that it will transfer Principal Supply status from Humira® (adalimumab) to Amgevita® (biosimilar adalimumab) from 01 March 2022.

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...