Celltrion seeks PBS listings for new biosimilars targeting osteoporosis, rheumatoid arthritis and other inflammatory diseases.
Australian rheumatologists will be keen to see the outcome of two biosimilars that are on the agenda for the next Pharmaceutical Benefits Advisory Committee meeting in November.
Denosumab and tocilizumab will go up for consideration along with a raft of other drugs to treat cancer, diabetes and weight loss, respiratory, gastroenterological and dermatological conditions, and sexual health.
Celltrion Healthcare Australia Pty Ltd has lodged an application requesting listings of two new denosumab biosimilars that mirror their respective originator brand’s current listings.Â
The new PBS listing request is for the treatment of osteoporosis, giant cell tumour of bone, and bone metastases.
The first of the two is commercially known as Stoboclo and is an injection (60mg in 1mL pre-filled syringe). The second, known as Osenvelt, is also an injection (120mg in 1.7mL)
Celltrion is seeking an authority required (streamlined) listing.
Denosumab is a fully human, high-specificity and high-affinity monoclonal antibody against receptor activator of nuclear factor kappa B ligand (RANKL). It has been registered for the treatment of osteoporosis in Australia since 2010 and is subsidised by the PBS for men and women aged >70 years with a T-score of –2.5 or less, and for men and women with a minimal trauma fracture. Denosumab is given as a subcutaneous injection of 60mg every six months.
The second biosimilar going to the next PBAC meeting is another from the Celltrion stable. The company is requesting listings of a new tocilizumab biosimilar that mirrors the originator brand’s current listings.
The request is for the treatment of severe active juvenile idiopathic arthritis, severe active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and active giant cell arteritis.
The drug, known as Avtozma, includes concentrate for injection 80mg in 4mL; concentrate for injection 200mg in 10mL; concentrate for injection 400mg in 20mL; injection 162mg in 0.9mL single use pre-filled pen; injection 162mg in 0.9mL single use pre-filled syringe.
Tocilizumab is a biological disease modifying antirheumatic drug (bDMARD), which blocks natural substances found in high amounts in the blood and joints of patients with rheumatoid arthritis.
These substances cause inflammation, which results in pain, joint swelling and stiffness, and can lead to joint damage. Tocilizumab blocks a cytokine called interleukin-6 (IL-6) so it can reduce inflammation, improve symptoms and help stop further joint damage.
The dDMARD is also used to treat other autoimmune conditions, such as juvenile idiopathic arthritis and giant cell arteritis.
The full PBAC November meeting agenda is here.