Apotex has secured tentative FDA approval for a generic injectable semaglutide, the active ingredient in Ozempic and Wegovy, developed in partnership with Orbicular Pharmaceutical Technologies.

The approval comes via Apotex Corp.’s ANDA, marking a milestone in expanding access to complex peptide therapies in the U.S.

Apotex is led by a Weston, Florida-based operation and is the U.S. affiliate of the large Canadian-based pharmaceutical company with a global footprint.

The development program with Orbicular emphasized advanced analytical characterization and deep process understanding to achieve the needed technical equivalence.

Apotex Chief Corporate Development Officer Barry Fishman highlighted collaboration and execution excellence as central to reaching the milestone.

Orbicular’s Managing Director, Dr. M. S. Mohan, underscored the regulatory rigor and scientific discipline required to demonstrate equivalence for a complex peptide product.

Health Canada targets a 180-day review window for generic drug applications, with pauses if data is missing; as of March, Canada was on track for generic semaglutide submissions, though regulator Q&A has caused some back-and-forth.

SOURCE: Apotex Corp.

Orbicular is a B2B specialty pharma company focused on complex generics and specialty products, offering capabilities in development, analytical characterization, regulatory strategy, and technology transfer.

Canada has not yet approved a generic semaglutide, despite generics becoming possible in January; Health Canada is reviewing multiple applications, including several from Apotex potentially in partnership with Orbicular.

Apotex is Canada's largest drug manufacturer and has ongoing plans for a global initial public offering, following its ownership change in 2022 when it was sold to SK Capital Partners.

The FDA tentative approval signals potential final approval ahead, which could broaden patient access to a key, affordable therapy.