As approved its second generic version of Ozempic (semaglutide injection), it notched up a positive development for India’s contract development and manufacturing organization (CDMO) OneSource Specialty Pharma, as well.
The generic version of Ozempic from Canadian-based Apotex, has been approved, Health Canada said, adding that it was the second generic approved, even as seven applications were being reviewed. Apotex has a partnership with Orbicular Pharmaceutical Technologies, who in turn have a partnership with OneSource.
OneSource said its partner Orbicular, along with its Canadian front-end partner, received an approval from Health Canada for generic Ozempic.
“This marks the second generic semaglutide approval in Canada, positioning OneSource partners as the first generic entrants in one of the world’s most significant semaglutide markets,” the company told the stock exchange.
OneSource’s first approval was through partner , who also received approval for generic semaglutide in Canada, late April.
Health Canada said, “The generic versions of semaglutide are complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug. Health Canada’s review ensures that differences between these products do not affect the safety, efficacy, or quality of the drug. 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 regulatory authority further said, Health Canada became the first G7 country to approve a generic version of semaglutide (end April.) Further, it added, that many generic medications were 45 to 90 percent cheaper than the brand name versions, in Canada.
Integrated model
Outlining its integrated development and manufacturing model, OnceSource said, Orbicular led the product development and technical program for the complex peptide, while OneSource supported the manufacturing – providing end-to-end manufacturing capabilities for the Canadian filing.
Commercial supply will be supported from OneSource’s United States Food and Drug Administration -approved flagship facility in Bengaluru, it said. The approval follows a recent tentative approval in the United States supported by OneSource, it added.
Neeraj Sharma, OnceSource Chief Executive and Managing Director, said, the development reflected “the strength of our CDMO platform, our compliance standards, technical expertise, and ability to scale complex drug-device-combination programs for highly regulated markets.”
The Canadian approval builds on several launches in India, where OneSource has been supplying brands marketed by multiple partners, after a basic patent on semaglutide expired in March, in markets including India, the company said.