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

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...

News

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug...

Insights

“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns
Registered Content

As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...

Insights

FDA issues draft guidance regarding “sameness” for Orphan Drug gene therapies
Registered Content

On Tuesday, FDA’s Center for Biologics Evaluation and Research (CBER) finalized six gene therapy guidances drafted in July 2018. With the Office of Orphan Products Development (OOPD), ...

Insights

Spending bill advances FDA biosimilars policy
Registered Content

On December 20, U.S. President Trump signed into law H.R. 1865, the “Further Consolidated Appropriations Act, 2020” (the Act), authorizing appropriations through September 30,...

Hogan Lovells Publications

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...

News

FDA mulls Orange Book overhaul to address patent listing, therapeutic equivalence, other issues

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic...

News

Four new FDA guidances and proposed rule advance biosimilars policy framework

Today, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological...

News

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from...

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