Australian Public Assessment Reports (AusPAR)

Dostiva and Dexeva are approved for preventing or managing cancer related bone complications and are biosimilars of Xgeva. Denolia and Deskeltia are approved for treating osteoporosis in men and postmenopausal women, as well as bone loss due to cancer therapies or long term glucocorticoid use and are biosimilars of Prolia.

Kavigale (sipavibart) has been approved for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments.

Briumvi (ublituximab) has been approved for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.

Andriga (abiraterone and prednisolone) has been approved for the treatment of prostate cancer.

Epyztek (ustekinumab) is approved for treatment of several conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti acetylcholine receptor (AChR) antibody positive.

Ixifi (infliximab) is approved for treatment of several conditions including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease, and ulcerative colitis.

Imdelltra (tarlatamab) has been provisionally approved for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Elfabrio (pegunigalsidase alfa) has been approved for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.

Lutathera has been approved for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours in adults.

Lynkuet is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Lytgobi (futibatinib) has been approved for the treatment of locally advanced or metastatic intrahepatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Hepcludex (bulevirtide) is approved for treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.

Ospomyv, Xborso (denosumab) have been approved for the prevention and treatment of multiple bone-related pathologies.

Rapiblyk is indicated for short‑term control of supraventricular tachycardia and ventricular rate in atrial fibrillation/flutter, and for non‑compensatory sinus tachycardia in adults. Not for chronic use.

Augtyro has been approved for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Sondelbay, Teriparintas and Teriparaccord have been approved for the treatment of osteoporosis.

Opuviz, a bioisimilar to Eylea, has been approved for multiple eye-related conditions.

Anzupgo (delgocitinib) has been approved for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.

Steqeyma (ustekinumab) has been approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, crohn's disease, and ulcerative colitis.

Osenvelt has been approved for the prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours. Stoboclo has been approved for the treatment of osteoporosis in postmenopausal women. Stoboclo significantly reduces the risk of vertebral, non-vertebral and hip fractures.

Sephience (sepiapterin) has been approved for the treatment of hyperphenylalaninaemia in adult and paediatric patients with phenylketonuria.

Nexobrid (anacaulase-bcdb) has been approved for eschar removal in adults and paediatric patients with deep partial thickness and/or full thickness thermal burns.

Enrylaze (crisantaspase) has been approved as a component of a multi-agent chemotherapeutic regimen, for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and paediatric patients (1 month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.

Afqlir; Enzeevu (aflibercept) 2 mg is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (wet AMD), CRVO, BRVO, DMEmyopic and CNV.