Read our latest updates & insights

FDA approves Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

Gene Techno Science and Kishi Kasei announce agreement for the joint development of an aflibercept biosimilar.

Pfizer releases positive interim analysis of data from clinical trials of Pfizer’s Inflectra®.

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.