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Health Canada โโapproved on Tuesday the first generic โversion of โDanish โ drugmaker โ Novo โNordisk’s Ozempic drug.
In a news release, the department said the submission for a generic semaglutide injection by Indian drugmaker Dr. Reddy’s Laboratories has been approved. It’s currently still reviewing eight other submissions by different companies.
In the next few weeks and months, it said it expects to make decisions on these submissions.
Health Canada said it approved Dr. Reddy’s submission after “a thorough review of evidence” found that the drug meets safety, efficacy and quality standards. It said this generic, like existing products, is indicated to be used for the “once-weekly treatment of adult patients with Type 2 diabetes to manage blood sugar levels.”
Health Canada added that generic semaglutide drugs are “pharmaceutically equivalent” to the brand-name version.
“The availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the healthcare system,” the department said in its news release.
It said it will continue to monitor the safety and effectiveness of all generic semaglutides.
More to come.
