Posted by Michael Wonder on 07 Apr 2021
Insights from the agenda for the July 2021 PBAC meeting
7 April 2021 - Notwithstanding the fact that it will be updated in week 8, this agenda looks different.
For starters, the mix of applicants is different:
- Five submissions from two Chinese pharmaceutical companies - Antagene and BeiGene. These are the first ever PBAC submissions from a Chinese pharmaceutical company,
- Submissions from other new comers - Maxx Pharma, Theramex, Chiesi, Eusa Pharma, Terumo
- No submissions from MSD, Roche & Amgen
The mix of medicines is also different. While there is a high number of submissions for new medicines (i.e. medicines not/never listed on the PBS), some of them are hardly new:
- Esketamine hydrochloride was first registered by the FDA in 1970 (albeit for another indication)
- Opicapone was first registered by the EMA in 2016
- Siltuximab was registered by the FDA and EMA in 2014
- Trabectedin was first registered by the EMA in 2007
Read PBAC agenda
Posted by:
Michael Wonder