News & Analysis as of

Pharmaceutical Industry › Competition › FDA Approval

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

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

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

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

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Fish & Richardson

FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book

Fish & Richardson on

On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Continues to Approve Biosimilars

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Hogan Lovells

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

Hogan Lovells on

On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more

Mintz - Health Care Viewpoints

FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition

Mintz - Health Care Viewpoints on

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for...more

Patterson Belknap Webb & Tyler LLP

FTC Competition Director Highlights Enforcement Priorities in the Pharmaceutical Industry

Patterson Belknap Webb & Tyler LLP on

Last week Markus Meier, the Acting Director of the Bureau of Competition at the Federal Trade Commission, gave testimony to the House Judiciary Committee concerning “Antitrust Concerns and the FDA Approval Process.” ...more

Mintz - Health Care Viewpoints

FDA Commissioner Hints at Drug Pricing-Related Initiatives

Mintz - Health Care Viewpoints on

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was...more

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