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This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more
On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article...more
On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more
On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more
Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more