Dr. Reddy's Generic Semaglutide Cleared NOD, NON Before Approval

Health Canada's Regulatory Decision Summary for Dr. Reddy's Laboratories' generic semaglutide injection shows the file cleared both a Notice of Deficiency and a Notice of Non-Compliance before receiving a Notice of Compliance on April 28, 2026 [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092].

Two regulatory hurdles before approval

According to the Regulatory Decision Summary, Health Canada first issued a Notice of Deficiency (NOD) citing insufficient data to demonstrate pharmaceutical equivalence between the proposed product and the Canadian Reference Product [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092]. The sponsor responded with updated clinical data and physical-chemical characterization data that partly addressed the objections [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092].

Given the product's high complexity, Health Canada then issued a Notice of Non-Compliance (NON) citing the need for further evidence of equivalence to the Canadian Reference Product and to address safety concerns related to impurities and product stability [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092]. The sponsor provided additional physicochemical characterization data generated using advanced scientific methodologies, addressing outstanding concerns about active ingredient similarity, safety, and shelf-life stability [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092].

Filed January 2024, approved April 2026

The Abbreviated New Drug Submission was filed on January 5, 2024, and authorized on April 28, 2026 [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092]. The approval made Canada the first G7 country to authorize a generic version of semaglutide, the active ingredient in Ozempic [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

Health Canada issued two Drug Identification Numbers for the product: 02567806 and 02567814 [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092]. Both DINs correspond to semaglutide at a concentration of 1.34 mg/mL, with strengths of 2 mg/1.5 mL and 4 mg/3.0 mL [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092]. The product is available by prescription only [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092].

Chemical synthesis versus biologic reference

The Regulatory Decision Summary explains that while the Canadian Reference Product Ozempic is a biologic drug manufactured using recombinant DNA technology, the active ingredient in Dr. Reddy's generic is produced using solid phase chemical synthesis [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092]. Cell-based assays demonstrated comparable potency, immunogenicity, and safety profiles between the generic and the reference product, with findings from a Phase 3 clinical trial providing supportive evidence [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092].

A human factor study demonstrated that the pre-filled pen could be used by patients in a similar manner to the reference product [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092]. Health Canada concluded that in vivo bioequivalence studies were not required, citing chemical, physicochemical and pharmaceutical equivalence along with semaglutide's uncomplicated pharmacokinetic characteristics [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092].

Eight more files in the queue

At the time of the April 28, 2026 announcement, Health Canada said it was reviewing eight other submissions for generic semaglutide from different companies, with regulatory decisions expected in the coming weeks and months [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. The department's published list of generic submissions under review tracks files by sponsor, therapeutic area, and submission month [Source: canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html].

Obesity Canada Scientific Director Dr. Sanjeev Sockalingam noted in commentary on the approval that additional generic submissions were under review as of April 28, 2026, and that fewer than 20 per cent of Canadians with private drug benefit plans have access to Health Canada-approved obesity treatment medications [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/]. Dr. Sockalingam wrote that Obesity Canada does not endorse specific medications, brands, or manufacturers [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/].

What the file does not change

The Regulatory Decision Summary covers the generic version of injectable semaglutide only. It does not affect other branded GLP-1 products tracked on GLP1Prices.ca, including Wegovy, Rybelsus, Mounjaro, and Zepbound. Readers can track new generic semaglutide listings on our generic semaglutide tracker and review payer rules through our insurance coverage checker or FAQ.

This article is for informational purposes only and does not constitute medical advice.