12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ.

The TGA has approved Octapharma's Cutaquig (human normal immunoglobulin) for use as replacement therapy in adults and children in:

• Primary immunodeficiency diseases
• Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment

The TGA has deemed it to be a 'new biological entity.' Really?  The TGA has approved many other formulations of human normal immunoglobulin:

• Hizentra (CSL Behring)
• Panzyga (Octapharma)
• Flebogamma (Grifols)
• Intragam (CSL Behring)
• Intratect (Link Healthcare)

While the TGA considered Cutaquig to be a new biological entity from an administrative perspective, in the real world it isn't. It is time for the TGA (and other regulatory agencies) to use real world definitions when they describe and tally outcomes for quasi new chemical and biological entities.

Read Australian prescription medicine decision summary for Cutaquig