Canada

Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.

Generics Bulletin reviews global regulatory developments across the world.

Dr Reddy's had not ruled out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Dr. Reddy's doesn’t fully rule out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

With Canadian approval secured, Biocon Biologics expects to launch its Stelara biosimilar rival shortly.

PharmaTher will use the power of artificial intelligence to propel the development of ketamine-based therapies.

Bio-Thera and Accord build on their North American golimumab biosimilar partnership, with Canada being a valuable market for both firms.

North America will enjoy further generic competition to Entresto, after Sandoz became the first company to launch a generic version of Novartis’ heart failure blockbuster in Canada.

Jamp has marked its entry into oncology biosimilars in Canada with the launch of its Kashiv-partnered filgrastim and pegfilgrastim rivals to Neupogen and Neulasta.

Celltrion has become the second denosumab biosimilar sponsor approved in Canada, more than a year after Sandoz’s approval in early 2024.

The latest report also demonstrates the EU’s trade relationships around the world, including with the US.

Sandoz and Delpharm will invest a total of CAD220m into the modernization of the CDMO’s Boucherville plant.