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AbbVie releases Third-Quarter results, showing an overall decrease in Humira® revenues of 3.7% due to biosimilar competition. While Humira® revenues continued to increase in the US by 9.6%, internationally revenues decreased by 33.5%.

Formycon announces dosing has begun in PhI clinical trials of ustekinumab biosimilar.

The CHMP adopts a positive opinion for Mundipharma’s pegfilgrastim candidate, recommending marketing authorisation be granted.

Celltrion presents pooled data from 3 post marketing studies of etanercept biosimilar, reporting that the study shows real-world evidence of the safety of the product.

Amgen releases results of Phase I clinical trials of infliximab biosimilar, reporting PK similarity as well as similar safety and immunogenicity profiles.

NeuClone announces it has commenced dosing in Phase I clinical trials of biosimilar ustekinumab candidate. 

Samsung executives admit subsidiary Archigen Biotech failed to develop a Rituxan biosimilar. The admission was made in Korean court court proceedings, with 8 executives and employees of Samsung facing accounting fraud charges.

Biocon and Evotec announce strategic licensing agreement for an early-stage biosimilar. Under this agreement, Biocon will take the asset through end-to-end development, IND filing, manufacturing and commercialisation and post-regulatory approval.

Roche announces results of Phase III clinical trials of MabThera/Rituxan® compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). Roche has announced that the results demonstrate Rituxan’s superiority over MMF for PV patients...

Polpharma publishes details of upcoming phase III clinical trials of biosimilar natalizumab candidate. The study will involve approximately 260 patients with relapsing-remitting multiple sclerosis.