Read our latest updates & insights

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.

Pfizer notifies the CHMP it wishes to withdraw its application for Fyzoclad®, biosimilar adalimumab, due to changes in the company’s strategy.  

The EMA accepts Celltrion’s application for a subcut formulation of biosimilar infliximab, Remsima SC®.

At the ASH Annual meeting, a paper was presented indicating positive results for Sandoz’s proposed RmAb biosimilar to EU reference drug, and concluding “efficacy, safety and immunogenicity, PK and PD of PF‑05280586 and rituximab-EU were similar up to Week 26 in ...

AbbVie announces a 7th global deal for biosimilar adalimumab. A non-exclusive royalty bearing license to Pfizer for AmAb will begin on 20 November 2023 in the US and on approval in the EU (no other dates disclosed).  Pfizer’s US launch date is the same as Momenta̵...