Dr Reddy's Laboratories becomes the first company to secure such market authorisation in a G7 country.
Key Points
- Dr Reddy's Laboratories (DRL) has secured Health Canada approval for its generic semaglutide injection, marking the first such approval in a G7 country.
- The market authorisation covers 2 mg and 4 mg pen dosage forms, positioning DRL to launch the generic version in Canada.
- This approval follows a six-month delay due to Health Canada's request for additional information and clarifications on DRL's submission.
- Canada is the first major Western market where semaglutide will lose exclusivity on January 4, 2026, creating a significant opportunity for generic manufacturers.
- The Canadian semaglutide market, valued at $1.17 billion in 2024, is projected to grow to over $4 billion by 2035, highlighting the market potential.
Dr Reddy's Laboratories (DRL) said on Wednesday it has received approval from Health Canada to sell a generic version of the diabetes drug semaglutide, ending months of regulatory delays and opening access to a major Western market.
"DRL has received a Notice of Compliance (NOC) from Health Canada for its generic semaglutide injection," the company said in a statement. The market authorisation covers dosage forms of 2 mg and 4 mg pens.
Pioneering Generic Approval
DRL is the first company to receive market authorisation for a generic semaglutide injection in Canada. It is the first generic semaglutide to be approved in a G7 country.
The approval comes almost six months after the Hyderabad-based drugmaker got a non-compliance notice from the Canadian health regulator in October last year.
Health Canada had requested additional information and clarifications on specific aspects of the submission -- a step that delayed the approval process.
"With launch preparations underway, DRL is well-positioned to bring this important treatment option to Canadian patients," the company said.
Market Opportunity and Impact
There is a rush to launch generic versions of semaglutide, as Danish drugmaker Novo Nordisk lost exclusive rights on the drug in major markets early this year.
Canada became the first major Western market to see semaglutide lose exclusivity on January 4 2026, positioning DRL to lead the first wave of generic launches.
Erez Israeli, chief executive officer of DRL, said Canada is a priority market and the company is dedicated to providing "innovative, high-quality and affordable glucagon-like peptide" treatment for diabetes patients in the country.
"Additionally, with our in-house development capabilities, we are committed to ensuring a reliable and consistent supply of this important therapy for Canadian patients," he said.
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Diabetes Prevalence in Canada
Around 3.9 million people in Canada (9.7 per cent of the population) live with diagnosed diabetes, according to the Public Health Agency. More than 6 per cent of adults have prediabetes, putting them at a higher risk of developing Type 2 diabetes.
Data from market research firm Garden View Research shows that the Canadian semaglutide market was valued at $1.17 billion in 2024, and is projected to reach over $4 billion by 2035.
On Wednesday DRL's shares ended the day's trade at ₹1,330.10 a piece on the BSE, down 1.82 per cent from the previous day's trade.
Feature Presentation: Rajesh Alva/Rediff
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