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Smart & Biggar

Update on biosimilars in Canada – June 2025

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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

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

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

Robins Kaplan LLP

Generic Launches

Robins Kaplan LLP on

Abbreviated New Drug Applications and 505(b)(2) Applications - This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug...more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more

Venable LLP

Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

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