Australian Public Assessment Reports (AusPAR)

AVTOZMA (tocilizumab), a biosimilar to ACTEMRA, has been approved to treat multiple autoimmune and inflammatory conditions.

DATROWAY (datopotamab deruxtecan) as a monotherapy is for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one additional systemic therapy in the locally advanced or metastatic setting.

IQIRVO (elafibranor) is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

OMLYCLO (omalizumab), a biosimilar to XOLAIR, is approved to treat allergic asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.

Pyrazinamide-AFT is indicated in adult patients of more than 12 years of age with active drug-sensitive tuberculosis caused by Mycobacterium tuberculosis. Pyrazinamide-AFT is an anti-tuberculosis agent used in combination with other anti- tuberculosis agents and is commonly used in the first 2 months of treatment.

Tyruko (natalizumab) is approved for treatment of patients with relapsing remitting multiple sclerosis (MS).

ITOVEBI (inavolisib), in combination with palbociclib and fulvestrant, is for the treatment of adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine therapy.

YORVIPATH (palopegteriparatide) is a parathyroid hormone analogue for the treatment of chronic hypoparathyroidism in adults.

VOYDEYA (danicopan) is indicated as an add-on to ravulizumab or eculizumab for the treatment of the signs or symptoms of extravascular haemolysis in adult patients with paroxysmal nocturnal haemoglobinuria.

RELFYDESS (relabotulinumtoxinA) is for the temporary improvement in the appearance of moderate to severe glabellar lines at maximum frown and of moderate to severe lateral canthal lines seen at maximum smile.

UPLIZNA (inebilizumab) is for the treatment of adult patients with neuromyelitis optica spectrum disorders who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

BYLVAY (odevixibat) is for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older.

Inrebic (fedratinib as hydrochloride) has been approved for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Rystiggo has been approved as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

TALVEY (talquetamab) has been provisionally approved for the treatment of adult patients with relapsed or refractory multiple myeloma.

CLASTO, ENOXACOR and ENOXAJECT (enoxaparin sodium) is a biosimilar to CLEXANE, an anticoagulant medication approved for multiple uses.

JOENJA (Leniolisib) is for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older

EPKINLY (epcoritamab) has been provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

VISTELLA (calcifediol) is for the treatment or prevention of vitamin D deficiency in adults.

FABHALTA (iptapocan) is for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

ZILBRYSQ (zilucoplan) is an add-on to standard therapy for the treatment of generalised myasthenia gravis in adult patients who are anti-acetylcholine receptor-antibody positive.

AWIQLI (insulin icodec) has been approved for the treatment, in adults, of type 2 diabetes and type 1 diabetes in conjunction with a bolus insulin, where daily basal insulin injections are not suitable.

Daxxify (daxibotulinumtoxinA) is for use in adults for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity and for the treatment of cervical dystonia.

Opsynvi (macitentan/tadalafil) is approved for maintenance treatment of pulmonary arterial hypertension in adult patients.

Litfulo (ritlecitinib) has been approved for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.