News & Analysis as of

Competition Biologics Pharmaceutical Industry

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

Rothwell, Figg, Ernst & Manbeck, P.C.

Biosimilars Boom: 2025’s Fast Track Approvals Look to Reshape Healthcare

With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more

Knobbe Martens

Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”

Knobbe Martens on

On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Biosimilars at the Crossroads: A $234 Billion Opportunity or a Missed Chance for Healthcare Savings?

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more

Goodwin

FDA’s Woodcock Reviews Patents Practices as a Way to Effect Drug Pricing

Goodwin on

On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more

Proskauer - The Patent Playbook

President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector

On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy...more

Haug Partners LLP

Can Biologics Manufacturers Face Antitrust Risk For Pointing Out That Biosimilars Are Different?

Haug Partners LLP on

Biologics are revolutionizing the pharmaceutical industry, and in doing so, garnering an increasing share of antitrust attention. In recent years, the FTC, FDA, and antitrust plaintiffs’ bar have raised concerns about a...more

Epstein Becker & Green

FDA and FTC Join Forces to Promote Biosimilars

Epstein Becker & Green on

The U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) (collectively, the “Agencies”) have a long history of teaming up to ensure that advertising and other promotional communications for...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Continues to Approve Biosimilars

The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more

Haug Partners LLP

FDA And FTC To Scrutinize Biologics Competition

Haug Partners LLP on

On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more

Mintz - Health Care Viewpoints

New Government Action Aims to Increase Competition among Biological Products: FDA and FTC Step Up Industry Pressure

Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more

Troutman Pepper Locke

Third Circuit Provides Manufacturers With Roadmap to Avoid Class Antitrust Claims Brought by Direct Purchasers

Troutman Pepper Locke on

The Third Circuit recently held in In re Remicade (Direct Purchaser) Antitrust Litigation that a direct purchaser’s antitrust suit alleging overpayment for a drug purchased pursuant to a distribution agreement with a...more

Goodwin

The Biologic Patent Transparency Act: Proposed Revisions to Purple Book

Goodwin on

Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed...more

Hogan Lovells

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

Hogan Lovells on

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 biosimilars, while preserving incentives...more

Womble Bond Dickinson

Basics of the BPCIA

Womble Bond Dickinson on

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Goodwin

JHU: Preliminary Evidence Supports Similarity of TNF-alpha Biosimilars To Reference Products

Goodwin on

In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an...more

Wilson Sonsini Goodrich & Rosati

FTC Workshop to Revisit Competition Issues Regarding Follow-On Biologics

Five years ago, the Federal Trade Commission (FTC) waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress...more

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