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FDA Approval Patent Litigation Interchangeability

Venable LLP

BiologicsHQ Monthly Injection - March 2025

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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

Spotlight On: Biosimilar Litigations - September 2024

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection – June 2024...more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

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