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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns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to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...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FDA issues draft guidance regarding “sameness” for Orphan Drug gene therapies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FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation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...

Publications

There'll be some changes made: President signs prescription drug and biologic user fee reauthorization act Pharmaceutical Client Alert

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and...

Hogan Lovells Publications

Guide to Recent Biosimilar Activity by FDA and in the Supreme Court Biosimilars Law Blog

The U.S. Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical...

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