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FDA approves TmAb biosimilar for the treatment of HER2-positive breast cancer. Herzuma® is the second TmAb biosimilar to be approved in the US. Celltrion is currently defending the biosimilar against Genentech, and while Genentech and Pfizer have reached a settlement, Cellt...

Xbrane submits first CTA to FDA for clinical trials of ranibizumab biosimilar candidate, Xlucane®. The Phase III trials will be conducted in patients with wet form of age-related macular degeneration.

Amgen files BLA for biosimilar infliximab.

NeuClone announces that it has biosimilar pertuzumab in preclinical development.

French study supports the use of Remsima® in the treatment of Crohn’s disease, showing equivalency to reference product in safety and effectiveness.

PBAC releases results from November PBAC meeting. The PBAC recommended Alphapharm’s Fulphila® for listing on the PBAC for all indications with “A” flagging.  Fulphila® and Amgen’s Neulasta® and Ristempa® brands of pegfilgrastim are now considered equ...

The EMA’s Committee for Medicinal Products for Human Use recommends approval of Pfizer’s BmAb biosimilar Zirabev®.  This is Pfizer’s second oncology biosimilar to receive positive EMA opinion this year.

Results of two year study demonstrate similar safety and efficacy between Celltrion’s Truxima® and the reference product in the treatment of advanced follicular lymphoma.

Innovent announces BmAb candidate met pre-defined endpoints in Phase III trials.

Genentech and Pfizer voluntarily dismiss all claims in litigation commenced in November 2017, each covering their own legal costs. While no details have been published, the dismissal suggests a settlement has been reached.