Regulatory Decision Summary for Glatect

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

glatiramer acetate

Therapeutic area:

Immunomodulator

Type of submission:

New Drug Submission

Control number:

191840
What was the purpose of this submission?

 

This New Drug Submission was filed to obtain market authorization for a second-entry glatiramer acetate product (Glatect) claiming to be equivalent to the current approved 20 milligram per millilitre (mg/mL) Copaxone formulation. The sponsor had conducted an extensive physico-chemical and nonclinical characterization along with clinical safety testing and a clinical equivalence trial in support of their objective to receive market authorization of Glatect.

 

Why was the decision issued?

 

A subsequent-entry drug is approved based on establishing that it contains identical medicinal ingredients to the Canadian Reference Product. With the exception of biosimilar biologic drugs, the majority of drugs are required to meet pre-specified pharmacokinetic equivalence standards for the measured drug content. Since glatiramer acetate breaks down at the injection site, it is not possible to derive drug pharmacokinetic measures that are used for equivalence assessments. Thus, comparisons between Glatect and Copaxone were based on non-clinical and clinical data requirements that were considered sufficient to reduce uncertainties with regard to establishing clinical equivalence. The equivalence to Copaxone has been shown based on surrogate Magnetic Resonance Imaging (MRI) outcomes, namely in reduction of the number of T1-gadolinium enhanced (T1-GdE) lesions during Months 7-9 of treatment within an acceptable pre-specified equivalence margin. Comparable safety profiles between Glatect and Copaxone were demonstrated by various metrics employed in studies ranging from nonclinical toxicology studies to studies conducted in humans, including a Phase I local tolerability trial (GTR002), a Phase III clinical equivalence trial (GTR001), and dedicated clinical immunogenicity assessments. The claim of equivalence between Glatect and Copaxone is based on extensive physico-chemical, non-clinical and clinical characterization.

 

Decision issued

Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.