16 February 2021 - The TGA thinks glatiramer acetate (Glatopa) is a new chemical entity.

Glatira, Multiros (solution for injection) was approved by the TGA in November 2020 for reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis.Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded. The TGA website states that Glatira/Multiros is a new chemical entity.

A search of the TGA website states that glatiramer acetate (Copaxone) 20 mg/mL solution for injection pre-filled syringe was entered on the ARTG on 17 December 2003. 

We think Glatira/Multiros is a new formulation of an existing medicine.