26 November 2021 - Some insights from the MAESTrO Team.

Sun Pharma has lodged a submission to list abiraterone acetate and methylprednisolone (co-packaged as opposed to co-formulated) for the treatment of patients with prostate cancer. The selection of methylprednisolone as the companion androgen seems a little odd given is generally use with prednisolone or prednisone. Having said that, the restrictions for abirateron acetate state that it must be used in combination with a corticosteroid.

A submission for another biosimilar for bevacizumab (Bevaciptin) has been lodged by Illuminate Health Consulting. This is the second time in a year a consultant has been noted in the agenda as the applicant/sponsor. We think Illuminate Health Consulting is the applicant but Cipla is the sponsor.  The TGA approval of Bevaciptin was noted recently on the TGA website with Cipla as the sponsor.

Astellas has lodged a submission for enfortumab vedotin (Padcev) for certain patients with bladder cancer.  The proposed target patient patient population is third-line (i.e. patients with progressive disease on or after treatment with a platinum-containing chemotherapy regimen and either a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor). The market for the PD-1/PD-L1 inhibitors for bladder cancer has changed; durvalumab is no longer registered by the TGS for use in bladder cancer and the approval for atezolizumab in the US has been withdrawn.

Novartis is taking a different tack for secukinumab (Cosentyx). After having failed to increase the maximum quantity from 1 to 2 for the 150 mg/mL solution in pre-filled syringes for injection, it is now seeking to list secukinumab in a higher strength (300 mg/2 mL solution in pre-filled syringes & pre-filled pens for injection).

Seqirus has lodged a submission to list Flucelvax Quad on the National Immunisation Program. Flucelvax Quad is an inactivated quadrivalent influenza vaccine prepared in cell cultures. Flucelvax Quad is the first cell-based influenza vaccine offered in Australia. Has Seqirus sought a price premium? Time will tell.

More insights on Monday.