Read our latest updates & insights

Sandoz announces at the EADV results from 51 week clinical study confirming that Sandoz’s biosimilar adalimumab matches Humira® in safety and efficacy profile.

Lupin secures external funding for its etanercept biosimilars program.

FDA accepts Sandoz’s s351(k) application for rituximab.

FDA accepts Adello Biologic’s BLA for biosimilar filgrastim.

Pfizer announces positive findings in pivotal Phase III study for TmAb candidate PF-05280014 at ESMO 17.

Amgen/Allergan present Phase III data on biosimilar trastuzumab ABP 980 at ESMO 2017.

PTAB denies institution of Coherus Biosciences’ 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation.

FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira’s biosimilar Inflectra® (infliximab-dyyb) is made.