Regulatory Decision Summary for Semaglutide Injection

The purpose of this Abbreviated New Drug Submission (ANDS) was to obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Semaglutide Injection 2 mg/1.5 mL (1.34 mg/mL semaglutide) and 4 mg/3.0 mL (1.34 mg/mL semaglutide) filed by Dr Reddys Laboratories Ltd, as the generic equivalent of the Canadian Reference Product (CRP) Ozempic, which is a biologic drug manufactured using recombinant deoxyribonucleic acid (DNA) technology and marketed by Novo Nordisk Canada. The active ingredient of the generic product is produced using solid phase chemical synthesis and not by recombinant DNA. This submission was filed for the once-weekly treatment of adults patients with type 2 diabetes mellitus to improve glycemic control.

Semaglutide Injection is a chemically synthesized product that was demonstrated to be comparable to the biologically produced Canadian Reference Product (CRP). Adequate physicochemical characterization data and comparative analysis were provided to support that the generic product and innovator product are pharmaceutically equivalent. Semaglutide Injection and Ozempic share the same dosage form, route of administration, and conditions of use. Cell-based assays demonstrated comparable potency, immunogenicity, and safety profiles between Semaglutide Injection and the CRP, with findings from a Phase 3 clinical trial providing supportive evidence. A human factor study demonstrated that the pre-filled pen could be used by patients in a similar manner to that of the CRP.

A Notice of Deficiency (NOD) was issued by Health Canada due to the insufficient data provided to demonstrate pharmaceutical equivalence of the proposed product with the CRP. In response to the NOD, the sponsor submitted updated clinical data, and physical-chemical characterization data which partly addressed the objections regarding pharmaceutical equivalence.

Given the product’s high complexity, a Notice of Non-Compliance (NON) was issued by Health Canada due to the further need for evidence demonstrating that the proposed generic product is equivalent to the CRP, and to address safety concerns related to impurities and product stability. In response, the sponsor provided additional physicochemical characterization data generated using advanced scientific methodologies and updated clinical data, addressing the outstanding concerns related to the similarity of the active ingredient, safety, and shelf-life stability of the product.

The chemistry and manufacturing information submitted for Semaglutide Injection has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

In light of the conclusion of chemical, physicochemical and pharmaceutical equivalence between the proposed Semaglutide Injection and the CRP, similar biologic effects, as well as semaglutide’s uncomplicated pharmacokinetic characteristics, in vivo bioequivalence studies were not required for this submission.

Following review and requested revisions, the final labelling and Product Monograph for Semaglutide Injection were considered acceptable.

A Risk Management Plan (RMP) for Semaglutide Injection was submitted by Dr Reddys Laboratory Ltd to Health Canada. Upon review, the RMP was considered to be acceptable.

Semaglutide Injection was considered equivalent to the CRP based on review of the totality of data, including quality information, biowaiver justification and documentation, non-clinical and clinical data, and labelling information. Therefore, Dr Reddys Laboratory Ltd was granted authorization to market the generic product in Canada.

For further details about Semaglutide Injection, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.