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Orange Book Biologics New Legislation

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

Hogan Lovells

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

Hogan Lovells on

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more

McDermott Will & Emery

An Early Holiday Present for Generics? Legislation Requiring Greater Disclosure by Brands Passes the Senate

McDermott Will & Emery on

Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more

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