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Australia’s TGA Approves New Brand of Novartis’ Ofatumumab

Aug 11, 2025

On 11 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved a new brand of Novartis’ ofatumumab:

  • ZOPHEOS ofatumumab 20 mg/0.4mL solution for injection pre-filled pen (490662)
  • ZOPHEOS ofatumumab 20 mg/0.4mL solution for injection pre-filled syringe (490650)

These presentations mirror Novartis’ previously approved ofatumumab product under the original Kesimpta® brand (approved March 2021), as well as second brand Bonspri™ (approved January 2022).  Kesimpta® was listed on Australia’s Pharmaceutical Benefits Scheme in October 2021.

Biosimilar competition for ofatumumab appears to be on the way, with Alvotech and Advanz Pharma announcing in May 2025 that they entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates in Europe, including biosimilars to Kesimpta®, as well as Novartis’ Ilaris® (canakinumab) and a third, undisclosed early-stage biosimilar.