19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved 43 real world new medicines in 2021.

The TGA approved 43 'new medicines' last year. These are comprised of:

• 30 new medicines
• 3 new combination products (where at least one component of the combination is new)
• 2 blood products
• 1 new diagnostic agent
• 2 new gene therapies
• 5 new vaccines

The TGA would have you believe it approved 50 new chemical entities last year. We argue the following 7 medicines are not new medicines in the real world:

• Rituxumab (Ruxience) - we think this is a new biosimilar medicine
• Follitropin alfa (Ovaleap) - we think this is a new biosimilar medicine
• Trientine dihydrochloride (Trientine-Reddy's, Trientine-RZ, Trientine Dr.Reddy's, Trientine-DRLA) - we think this a new formulation of trientine dihydrochloride (Trientine Waymade) which was approved by the TGA on 11 January 2021
• Immunoglobulin (human) (Cutaquig) - we think this a new formulation of human immunuglobulin
• Trientine tetrahydrochloride (Cuprior) - we think this a new formulation of trientine  which was approved by the TGA on 11 January 2021
• Zanubrutinib (Brukinsa) - we consider its approval for patients with mantle cell lymphoma on 8 November 2021 to be a new indication given it was approved on 7 November 2021 for patients with Waldenström's macroglobulinaemia
• Bevacizumab (Bevacip, Bevaciptin) - we think this is a new biosimilar medicine

Given we are still in a global pandemic, it should come as no surprise that 10 of the 43 'new medicines" are for infectious disease.  Five medicines are for cancer and another five are for a haematological condition.

10 of the 43 'new medicines' were granted provisional registration.

16 of the 43 'new medicines' are orphan drugs; five of the 43 'new medicines' were granted priority review.

The mean period from the date of the commencement of evaluation to the date of ATRG entry for the 43 'new medicines' was 326 days. We will compare this value with those of recent years in an upcoming issue of MAESTrO Daily.