Glatiramer Acetate (GA)/Copaxone API Sameness Models

Hooke has extensive experience running studies to establish active pharmaceutical ingredient (API) sameness of generic GA and Teva Copaxone, as well as developing models for that purpose.

The FDA recommends that generic GA sponsors conduct testing in at least two EAE assays (one prophylactic and one therapeutic). Hooke routinely performs these assays.

Sameness models

Hooke recommends three models of experimental autoimmune encephalomyelitis (EAE) for assessment of generic GA sameness:

In each model, mice are treated with the Reference Listed Drug (RLD) Teva Copaxone, the generic GA test compound, or vehicle, and clinical symptoms of EAE are monitored for 28 days.

Hooke can also induce disease using spinal cord homogenate-induced EAE in (BALB/c x SJL)F1 mice, but our experience is that the three models listed above are more robust.

Typical results

Results from studies conducted at Hooke in each of the three models are shown below.

Copaxone dosed prophylactically in MOG35-55/CFA-induced EAE

MOG35-55 EAE Teva Copaxone typical results
Copaxone dosed prophylactically in [Ser140]-PLP139-151/CFA-induced EAE

PLP139-155 EAE Teva Copaxone typical result
Copaxone dosed therapeutically in adoptive transfer EAE

Adoptive transfer EAE Teva Copaxone typical result

Please contact Hooke at or with questions or for a quotation.

See also