On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease and ulcerative colitis.
This is the second approval for a Pfizer-sponsored infliximab biosimilar, with Inflectra® having been the first infliximab biosimilar approved in Australia in November 2015.
On 26 September 2024, the TGA provisionally approved Janssen’s Talvey® (talquetamab) in 2mg/ml and 40mg/ml solutions for injection vial for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Talvey® was granted accelerated approval in the US by the FDA in August 2023.
Also on 26 September 2024, Celltrion’s Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), received Australian approval for a lower dose of 20mg/0.2ml solution for injection pre-filled syringe. Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (30 June 2023) forms and was PBS listed in March 2023 (40mg/0.4ml).