Canada

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

Roberto Khoury, Perrigo’s international lead for a year, moves to CCO while his counterpart for the Americas region appointed in September 2023, Catherine "Triona" Schmelter, is leaving with her post eliminated in the firm’s changes.

Canada will welcome its first Eylea off-patent rival in July, as Biocon Biologics celebrates the commercialization of its 10th biosimilar worldwide.

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

Several years after the initial signing of their agreement, Formycon and Fresenius Kabi announced the launch of their Stelara biosimilar Otulfi in Canada, adding another key market to their list.

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

Sunshine Biopharma is continuing to roll out generic launches in Canada, with its latest product challenging Afinitor and other everolimus rivals in the market.

Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

Along with financial backing from the Canadian government, a fresh, decade-long partnership with Sandoz Canada will allow Delpharm to carry out modernization plans for its manufacturing facility in Boucherville, securing the local supply chain for sterile injectable medicines.

Celltrion has become the latest firm to enter the competitive US market for Stelara biosimilars, revealing details of its Steqeyma launch.

After receiving an approval for the Neulasta rival in the US in May 2022, Kashiv BioSciences has now added a further North American country with a positive nod from Canada’s health agency.