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Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring...

News

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“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns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to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...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FDA issues draft guidance regarding “sameness” for Orphan Drug gene therapies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,...

News

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways Focus On Regulation

On 9 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application," that contains minor...

News

FDA’s Bendeka decision reverses approvals of Treanda generics Focus On Regulation

On 20 February 2019 the U.S. Food and Drug Administration (FDA) released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle...

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FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation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

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