Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilar Deals 2025
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Helen Macpherson
Intranet
Kimberley Evans
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

Australia’s PBAC Recommends New and Amended PBS Listings for AbbVie’s Humira®; BMS’ Opdivo® Rejected for NSCLC

Jan 31, 2025

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.

Abbvie’s Humira® (adalimumab) received a number of recommendations, including:

  • new PBS listings for enthesitis/spondylitis related JIA and chronic plaque psoriasis for paediatric patients; and
  • amended PBS listings for moderate to severe ulcerative colitis and severe Crohn’s disease to allow dose escalation and more flexible dosing.

This follows PBS-listing of Sandoz’s high concentration adalimumab biosimilar, Hyrimoz®, in January 2025.

BMS’ PBS submission for Opdivo® (nivolumab) for the perioperative treatment of patients with resectable non-small cell lung cancer (NSCLC) was not recommended.  BMS has requested a post-PBAC meeting to look for a pathway to achieve PBS-listing for this indication.

Opdivo® is currently under review by Australia’s Therapeutic Goods Administration (TGA) for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.