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Australian Advisors Will Ponder Sandoz’ Pegfilgrastim And Pfizer’s Trastuzumab

 
• By Aidan Fry

A body that advises Australia’s Department of Health on reimbursement will in November consider listing applications for Sandoz’ Ziextenzo pegfilgrastim candidate and well as for Pfizer’s recently authorized Trazimera trastuzumab brand.

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Australian reimbursement may be on the cards for Sandoz' Ziextenzo and Pfizer's Trazimera • Source: Shutterstock

An Australian advisory body will consider reimbursement terms for Sandoz’ prospective Ziextenzo pegfilgrastim biosimilar when it next convenes in November. Also on the November agenda of the country’s Pharmaceutical Benefits Advisory Committee will be a requested listing for the Trazimera (trastuzumab) oncology biosimilar for which Pfizer has just secured Australian marketing authorizations in 60mg and 150mg powder for injection formulations. The deadline for public comments is 9 October.

Ziextenzo is not yet listed as approved in the Australian Register of Therapeutic Goods. Nevertheless, Sandoz has asked the PBAC to consider in November whether the biosimilar pegfilgrastim 6mg/0

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Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Generics Bulletin Explains: The Landscape For Denosumab Biosimilar Competition

 
• By Dave Wallace

One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

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After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.