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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.

Alphapharm receives TGA approval for its biosimilar TmAb in Australia (Ogivri®) in 2 dosage forms (150mg, and 440mg powder for injection), four months after Celltrion received approval for its TmAb biosimilar products on 17 July 2018.

Samsung Bioepis announces comparable efficacy and safety to reference Trastuzumab in one-year follow-up study published at the San Antonio Breast Cancer Symposium.