Read our latest updates & insights

AU’s PBAC has confirmed that Amgen and Samsung’s biosimilar adalimumab (respectively Amgevita and Hadlima) will be “A-flagged”, enabling pharmacy substitution.

Coherus announces that it received a positive response from the CHMP for its pegfilgrastim biosimilar.

Sandoz announces EC approval for Hyrimoz®, biosimilar adalimumab for use in all indications.

Mylan and Fujifilm announce positive response from CHMP for biosimilar adalimumab for use in all indications. 

Glenmark releases Phase I results of biosimilar omalizumab, suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles to Xolair®.

Dr Reddy’s announces biosimilar trastuzumab available in India for the treatment of HER2-positive cancers.

Teva launches first biosimilar filgrastim in South Africa at 70% of the price of Amgen’s product. This comes more than 5 years after Teva first sought regulatory approval, demonstrating the backlog of products awaiting approval from the South African Health Products R...

Pfizer announces FDA approval of Pfizer’s Nivestym®, biosimilar to filgrastim for all indications.

AbbVie announces a global settlement with Mylan under which Mylan acknowledges Humira® AbbVie’s patents are valid, and Mylan receives a royalty-bearing, non-exclusive global license (excluding Europe) from 31 July 2023.  This date will not be accelerated by entry of A...

Celltrion obtains approval for its biosimilar TmAb products in Australia (150mg products branded as Simabtra®, Herzuma®, and Hertuzu®).  These are the first biosimilar TmAb products to be approved in AU.