On 21 August 2025, New Zealand’s Medsafe approved Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), in 100mg IV formulation for all reference indications.
Ixifi® will be the second infliximab biosimilar available in New Zealand, following Celltrion’s Remsima® (SC formulation, 120mg/ml pre-filled pen and pre-filled syringe), approved in June 2023.
Pfizer’s Inflectra® branded infliximab biosimilar (100mg IV formulation) was initially approved by Medsafe in September 2015, but the company no longer supplies or markets the product. Similarly, Samsung Bioepis’ infliximab biosimilar, Renflexis® (100mg IV formulation), was approved by Medsafe in March 2023, but is also no longer supplied or marketed in New Zealand.
Pfizer and Celltrion entered into a 2009 agreement for biosimilar infliximab, with Pfizer holding exclusive commercialisation rights in the US and certain other jurisdictions. In March 2025, Celltrion announced the rebrand of Inflectra® (IV formulation) to Remdantry™ in Canada. According to Celltrion, the rebrand reflected its “consolidation of both the intravenous (IV) and subcutaneous (SC) formulations” being directly commercialised by Celltrion in Canada in order to “provide healthcare professionals with a more streamlined prescribing experience”.