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Department of Justice (DOJ) Biosimilars Biologics

Troutman Pepper Locke

Second FTC and DOJ Listening Session Focuses on Formulary and Benefit Practices and Regulatory Abuse in the Pharmaceutical...

Troutman Pepper Locke on

On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2018

Goodwin on

Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan - In July, FDA released the Biosimilar Action Plan (BAP), which outlines...more

Faegre Drinker Biddle & Reath LLP

Biologic and Biosimilar Settlement Agreements Now Must Be Disclosed to DOJ and FTC

Recent amendments to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), titled the Patient Right to Know Drug Prices Act, require parties to inform regulatory authorities of executed settlement...more

K&L Gates LLP

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

K&L Gates LLP on

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

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