Regulatory Decision Summary for Teva-Teriparatide Injection
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.
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What was the purpose of this submission?
This Abbreviated New Drug Submission (ANDS) was filed to obtain market authorization for a generic form of Teriparatide by Teva Canada Limited (Ltd). Teva-Teriparatide Injection contains 20 micrograms of the active ingredient, Teriparatide, in 80 microliters of solution. The drug product is provided in an autoinjector which provides sufficient quantity of the drug for 28 days of dosing. Teriparatide is a bone formation agent indicated:
- For the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy.
- To increase bone mass in men with primary or hypogonadal severe osteoporosis who have failed or are intolerant to previous osteoporosis therapy.
- For the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture.
Teriparatide is human parathyroid hormone (1-34) and has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone (PTH). The Canadian Reference Product (CRP), Forteo (Eli Lilly Canada Inc.), is a biologic drug manufactured using recombinant DNA technology. The active ingredient of the proposed generic product is produced using solid phase chemical synthesis and not via the recombinant DNA route. Therefore, it is classified as a pharmaceutical drug substance rather than a biologic.
Why was the decision issued?
The drug product was found to meet the regulatory definition for pharmaceutical equivalence as it contains the identical medicinal ingredient in the identical quantity as the CRP, as well as being administered via the same route of administration and sold in a comparable dosage form, and as such is eligible for authorization via the ANDS pathway.
Teva Canada Ltd. has provided results from the comparative analysis of Teva-Teriparatide against the CRP, Forteo. The totality of the characterization data submitted is considered adequate to confirm that the innovator product and the proposed generic product are a single chemical entity. Adequate characterisation data was provided to support that the generic product and innovator product are chemically equivalent and hence meet the requirements of the policy Interpretation of "Identical Medicinal Ingredient". Further, comparative data was provided to support that the generic product and the innovator product exhibit similar biologic effects. The autoinjector was authorized as it met acceptable standards and the patient would be able to use the injector in a similar manner to that of the innovator product.
The drug substance and drug product are manufactured in a consistent manner.
In light of the conclusion of chemical, physicochemical and pharmaceutical equivalence between Teva-Teriparatide Injection and the CRP, similar biologic effects, as well as teriparatides uncomplicated pharmacokinetic characteristics, in vivo bioequivalence studies were not required for this submission.
Teva Canada Ltd. was granted authorisation to market the generic product.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TEVA-TERIPARATIDE INJECTION | 02486423 | TEVA CANADA LIMITED | TERIPARATIDE (TERIPARATIDE ACETATE) 250 MCG / ML |