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Inter Partes Review (IPR) Proceeding Orange Book BPCIA

Venable LLP

Spotlight On: Biosimilar Litigations - June 2025

Venable LLP on

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

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

Foley & Lardner LLP on

As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

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