| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT VALINE, LEUCINE AND ISOLEUCINE |
MSUD express 15® |
VITAFLO AUSTRALIA PTY LIMITED |
Short-chain Enoyl co-A Hydratase (ECHS1) deficiency and 3-Hydroxyisobutyryl co-A Hydrolase
(HIBCH) deficiency |
Jul 2026 |
Pending PBAC outcome |
| AFLIBERCEPT |
Eydenzelt® |
CELLTRION HEALTHCARE AUSTRALIA PTY LTD |
Branch retinal vein occlusion with macular oedema; Central retinal vein occlusion
with macular oedema; Diabetic macular oedema; Subfoveal choroidal neovascularisation
due to age-related macular degeneration |
Jul 2026 |
Pending PBAC outcome |
| ANIFROLUMAB |
Saphnelo® |
ASTRAZENECA PTY LTD |
Systemic lupus erythematosus (SLE) |
Jul 2026 |
Pending PBAC outcome |
| BLINATUMOMAB |
Blincyto® |
AMGEN AUSTRALIA PTY LIMITED |
Acute lymphoblastic leukaemia (ALL) Precursor B-cell ALL (Pre-B-cell ALL) |
Jul 2026 |
Pending PBAC outcome |
| BUDESONIDE WITH GLYCOPYRRONIUM AND FORMOTEROL |
Breztri Aerosphere® |
ASTRAZENECA PTY LTD |
Severe asthma |
Jul 2026 |
Pending PBAC outcome |
| AZACITIDINE |
- Azacitidine Accord®
- Azacitidine Dr Reddy’s®
- Azacitidine Euglia® Azacitidine Juno® Azacitidine MSN® Azacitidine Sandoz®
- Azacitidine SXP®
|
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Acute Myeloid Leukemia; Myelodysplastic syndrome; Chronic Myelomonocytic Leukemia |
Jul 2026 |
Pending PBAC outcome |
| DUPILUMAB |
Dupixent® |
SANOFI-AVENTIS AUSTRALIA PTY LTD |
Chronic severe atopic dermatitis |
Jul 2026 |
Pending PBAC outcome |
| ELTROMBOPAG |
Revolade® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Severe aplastic anaemia Severe thrombocytopenia |
Jul 2026 |
Pending PBAC outcome |
| DELGOCITINIB |
Anzupgo® |
LEO PHARMA PTY LTD |
Chronic hand eczema (CHE) |
Jul 2026 |
Pending PBAC outcome |
| ETONOGESTREL |
Implanon NXT® |
ORGANON PHARMA PTY LTD |
Contraception |
Jul 2026 |
Pending PBAC outcome |
| ONASEMNOGENE ABEPARVOVEC |
OAV101 IT® |
NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED |
Spinal muscular atrophy (SMA) |
Jul 2026 |
Pending PBAC outcome |
| USTEKINUMAB |
Steqeyma® |
CELLTRION HEALTHCARE AUSTRALIA PTY LTD |
Severe chronic plaque psoriasis; Severe psoriatic arthritis; Severe Crohn disease;
Complex refractory fistulising Crohn disease; Moderate to severe ulcerative colitis |
Jul 2026 |
Pending PBAC outcome |
| TEPROTUMUMAB |
Tepezza® |
AMGEN AUSTRALIA PTY LIMITED |
Thyroid eye disease (TED) |
Jul 2026 |
Pending PBAC outcome |
| GUSELKUMAB |
Tremfya® |
JANSSEN-CILAG PTY LTD |
Severe Crohn disease (CD) |
Jul 2026 |
Pending PBAC outcome |
| PROGESTERONE |
Utrogestan® |
BESINS HEALTHCARE AUSTRALIA PTY LTD |
Unexplained threatened miscarriage |
Jul 2026 |
Pending PBAC outcome |
| DEPEMOKIMAB |
Exdensur® |
GLAXOSMITHKLINE AUSTRALIA PTY LTD |
Uncontrolled severe eosinophilic asthma |
Jul 2026 |
Pending PBAC outcome |
| EPCORITAMAB |
Epkinly® |
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Relapsed or refractory diffuse large B-cell lymphoma |
Jul 2026 |
Pending PBAC outcome |
| CLOZAPINE |
Clozaril® |
VIATRIS PTY LTD |
Schizophrenia |
Jul 2026 |
Pending PBAC outcome |
| SEBELIPASE ALFA |
Kanuma® |
ALEXION PHARMACEUTICALS PTY LIMITED |
Late-onset lysosomal acid lipase deficiency (LAL-D) |
Jul 2026 |
Pending PBAC outcome |
| VUTRISIRAN |
Amvuttra® |
MEDISON PHARMA AUSTRALIA PTY LIMITED |
Transthyretin amyloid cardiomyopathy (ATTR-CM) |
Jul 2026 |
Pending PBAC outcome |
| EVOLOCUMAB |
Repatha® |
AMGEN AUSTRALIA PTY LIMITED |
Non-familial hypercholesterolaemia; Familial heterozygous hypercholesterolaemia; Familial
homozygous hypercholesterolaemia |
Jul 2026 |
Pending PBAC outcome |
| PEGZILARGINASE |
Loargys® |
ILLUMINATE HEALTH CONSULTING PTY LIMITED |
Arginase 1 deficiency (ARG1-D) |
Jul 2026 |
Pending PBAC outcome |
| BELANTAMAB MAFODOTIN |
Blenrep® |
GLAXOSMITHKLINE AUSTRALIA PTY LTD |
Relapsed and/or refractory multiple myeloma (MM) |
Jul 2026 |
Pending PBAC outcome |
| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT LYSINE AND LOW IN TRYPTOPHAN |
- GA1 Anamix Infant®
- GA1 Anamix Junior®
|
NUTRICIA AUSTRALIA PTY LTD |
Pyridoxine‑Dependent Epilepsy (PDE) |
Jul 2026 |
Pending PBAC outcome |
| MIFEPRISTONE AND MISOPROSTOL |
MS-2 Step® |
MS HEALTH PTY LTD |
Termination of an intra-uterine pregnancy |
Jul 2026 |
Pending PBAC outcome |
| DARATUMUMAB |
Darzalex SC® |
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Newly diagnosed systemic light chain amyloidosis; Untreated multiple myeloma; Relapsed
and/or refractory multiple myeloma |
Jul 2026 |
Pending PBAC outcome |
| DONIDALORSEN |
Zirdawny® |
OTSUKA AUSTRALIA PHARMACEUTICAL PTY. LTD |
Hereditary angioedema |
Jul 2026 |
Pending PBAC outcome |
| PIRTOBRUTINIB |
Jaypirca® |
ELI LILLY AUSTRALIA PTY LTD |
Chronic lymphocytic leukaemia (CLL) Small lymphocytic lymphoma (SLL) |
Jul 2026 |
Pending PBAC outcome |
| ELEXACAFTOR WITH TEZACAFTOR AND WITH IVACAFTOR, AND IVACAFTOR |
Trikafta® |
VERTEX PHARMACEUTICALS (AUSTRALIA) PTY. LTD. |
Cystic fibrosis |
Jul 2026 |
Pending PBAC outcome |
| FINERENONE |
Kerendia® |
BAYER AUSTRALIA LTD |
Heart failure |
Jul 2026 |
Pending PBAC outcome |
| ESTRADIOL WITH PROGESTERONE |
Bijuva® |
THERAMEX AUSTRALIA PTY LTD |
Vasomotor symptoms in post-menopausal women |
Jul 2026 |
Pending PBAC outcome |
| TEPLIZUMAB |
Tzield® |
SANOFI-AVENTIS AUSTRALIA PTY LTD |
Type 1 diabetes (T1D) |
Jul 2026 |
Pending PBAC outcome |
| USTEKINUMAB |
Yesintek® |
GENERIC HEALTH PTY LTD |
Severe chronic plaque psoriasis; Severe psoriatic arthritis; Severe Crohn disease;
Complex refractory fistulising Crohn disease; Moderate to severe ulcerative colitis |
Jul 2026 |
Pending PBAC outcome |
| AMIVANTAMAB |
Rybrevant SC® |
JANSSEN-CILAG PTY LTD |
Non-small cell lung cancer (NSCLC) |
Jul 2026 |
Pending PBAC outcome |
| BEMPEDOIC ACID BEMPEDOIC ACID WITH EZETIMIBE |
|
SEQIRUS (AUSTRALIA) PTY LTD |
Hypercholesterolaemia |
Jul 2026 |
Pending PBAC outcome |
| ATEZOLIZUMAB |
Tecentriq SC® |
LICENSED STERILE COMPOUNDERS OF AUSTRALIA LIMITED |
Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular
carcinoma; Extensive-stage small cell lung cancer; Resected early stage (Stage II
to IIIA) non-small cell lung cancer; Locally advanced or metastatic non-small cell
lung cancer; Stage IV (metastatic) non-small cell lung cancer |
Jul 2026 |
Pending PBAC outcome |
| BRIVARACETAM |
Briviact® |
UCB AUSTRALIA PROPRIETARY LIMITED |
Intractable focal onset seizures |
Jul 2026 |
Pending PBAC outcome |
| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT VALINE, LEUCINE AND ISOLEUCINE |
- MSUD Anamix Infant®
- MSUD Anamix Junior®
- MSUD Lophlex LQ 20®
- MSUD Maxamum®
|
NUTRICIA AUSTRALIA PTY LTD |
Short-chain enoyl-CoA hydratase (ECHS1) deficiency |
Jul 2026 |
Pending PBAC outcome |
| ACALABRUTINIB |
Calquence® |
ASTRAZENECA PTY LTD |
Mantle cell lymphoma (MCL) |
Jul 2026 |
Pending PBAC outcome |
| ELACESTRANT |
Orserdu® |
A.MENARINI AUSTRALIA PTY LIMITED |
Breast cancer |
Jul 2026 |
Pending PBAC outcome |
| TISLELIZUMAB |
Tevimbra® |
BEONE MEDICINES AUS PTY LTD |
Gastro-oesophageal cancer |
Jul 2026 |
Pending PBAC outcome |
| APADAMTASE ALFA / CINAXADAMTASE ALFA |
Adzynma® |
TAKEDA PHARMACEUTICALS AUSTRALIA PTY. LTD. |
Congenital thrombotic thrombocytopenic purpura (cTTP) |
Jul 2026 |
Pending PBAC outcome |
| METHOXSALEN |
Uvadex® |
HEALTH TECHNOLOGY ANALYSTS PTY LIMITED |
Cutaneous T-cell lymphoma (CTCL) Chronic graft versus host disease (cGVHD) |
Jul 2026 |
Pending PBAC outcome |
| BRENTUXIMAB VEDOTIN |
Adcetris® |
TAKEDA PHARMACEUTICALS AUSTRALIA PTY. LTD. |
Hodgkin lymphoma |
Jul 2026 |
Pending PBAC outcome |
| AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT VALINE, LEUCINE, ISOLEUCINE
AND SUPPLEMENTED WITH ARACHIDONIC ACID AND DOCOSAHEXAENOIC ACID |
MSUD explore5® |
VITAFLO AUSTRALIA PTY LIMITED |
Short-chain Enoyl co-A Hydratase (ECHS1) deficiency and 3-Hydroxyisobutyryl co-A Hydrolase
(HIBCH) deficiency |
Jul 2026 |
Pending PBAC outcome |
| LONCASTUXIMAB TESIRINE |
Zynlonta® |
SWEDISH ORPHAN BIOVITRUM PTY LTD |
Diffuse large B-cell lymphoma (DLBCL) |
Jul 2026 |
Pending PBAC outcome |
| PEGCETACOPLAN |
Empaveli® |
SWEDISH ORPHAN BIOVITRUM PTY LTD |
Complement 3 glomerulopathy (C3G) or primary immune complex membranoproliferative
glomerulonephritis (IC-MPGN) |
Jul 2026 |
Pending PBAC outcome |
| BIRCH TRITERPENES |
Filsuvez® |
CHIESI AUSTRALIA PTY LTD |
Dystrophic or junctional epidermolysis bullosa (EB) |
Jul 2026 |
Pending PBAC outcome |
| ODEVIXIBAT |
Bylvay® |
IPSEN PTY LTD |
Alagille syndrome (ALGS) |
Jul 2026 |
Pending PBAC outcome |