TocilizumabActemra

5.1 The PBAC recommended the General Schedule Authority Required and Section 100 (Highly Specialised Drugs Program) Authority Required listings of a new tocilizumab biosimilar on a cost-minimisation basis and under the same conditions as its reference biologic (Actemra®), for the same indications.PSD · Nov 2025

5.2 The PBAC advised the equi-effective doses to be 1 mg Avtozma = 1 mg Actemra.PSD · Nov 2025

5.7 The minor submission presented a cost-minimisation analysis against tocilizumab IV over a 52-week period (Table 1 below).PSD · Mar 2020

5.8 The minor submission proposed the following equi-effective doses:  tocilizumab 162 mg administered as SC injection (every 2 weeks for patients < 30 kg or every week for patients  30 kg) and  tocilizumab administered as an IV infusion every 2 weeks (12 mg/kg for patients < 30 kg or 8 mg/kg for patients  30 kg).PSD · Mar 2020

5.5 The minor submission claimed that based on data from the JIGSAW 117 trial, tocilizumab SC is equivalent in efficacy and safety to IV tocilizumab.PSD · Mar 2019

4.3 As per the Product Information, the TGA has confirmed that “Avtozma is a biosimilar medicine to Actemra. The comparability of Avtozma with Actemra has been demonstrated with regard to physiochemical characteristics and efficacy and safety outcomes. The evidence for comparability supports the use of Avtozma for the listed indications.”PSD · Nov 2025

6.1 The PBAC previously considered that an RSA with a '''''''% rebate above the caps would be required given the uncertain GCA incidence rate and the potential for use outside the proposed restriction (Paragraph 7.15, Tocilizumab November 2018 PBAC PSD).PSD · Mar 2019

6.2 The minor resubmission acknowledged that there is uncertainty regarding the incidence of GCA and potential for use outside the restriction, and stated it was willing to agree to an RSA with a ''''''''% rebate for any PBS expenditure exceeding the cap outlined in Table 2.PSD · Mar 2019