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Competition › FDA Approval › Drug Pricing

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

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

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

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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