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On 2 August 2024, Australia’s Therapeutic Goods Administration announced that, according to Novo Nordisk, Wegovy® (semaglutide), specifically indicated for weight loss, will be available in Australia from early August 2024. While Wegovy® has been approved in Australia since...

On 1 August 2024, Xbrane Biopharma announced that it will regain full rights to XcimzaneTM (BIIB801) biosimilar to UCB’s Cimzia® (certolizumab pegol) for rheumatoid arthritis and psoriasis.  Xbrane and Biogen had entered into a commercialisation and licensing agreement in F...

On 1 August 2024, Pharmacy Daily reported that Bristol Myers Squibb’s (BMS) Opdivo® (nivolumab) has had a new indication for resectable non-small cell lung cancer (NSCLC) listed on Australia’s Pharmaceutical Benefits Scheme (PBS).  It now joins MSD’s Keytruda® (pembrolizuma...

On 1 August 2024, the PBS published its Summary of Changes, which included listing Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 20mg/0.4mL and 40mg/0.8mL dosage injections.

This comes three years after Abrilada was first recommended ...

On 1 August 2024, GSK announced that the FDA has approved Jemperli® (dostarlimab) in combination with carboplatin and paclitaxel followed by Jemperli® as a single agent for treating primary advanced or recurrent endometrial cancer.  This expands the previous indication for ...

On 1 August 2024, Navlin Daily reported that Brazil’s National Commission for the Incorporation of Technologies into the Unified Health System (CONITEC) recommended against incorporating rituximab monotherapy in Brazil’s national health system for treating asymptomatic foll...

On 31 July 2024, Celltrion reported that Health Canada has approved its new drug licence application for Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

The Health Canada approval foll...

On 31 July 2024, Zydus Lifesciences announced it has received approval from the Mexican Regulatory Authority, COFEPRIS, to market Mamitra™, biosimilar to Roche’s Herceptin® (trastuzumab), for HER2+ metastatic and early breast cancer and advanced gastric cancer.

The f...

The Australian Pharmaceutical Benefits Assessment Committee (PBAC) November meeting promises to be a significant one for biopharmaceuticals based on the agenda published on 31 July 2024.

Two biosimilars will be considered: Sandoz’s Wyost® (denosumab) (biosimilar to A...

As previously reported, on 9 April 2024, Novartis and Genentech commenced proceedings in the Dusseldorf Local Division of the UPC (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion in relation to EP 2805248 regarding pharmaceuti...