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Anti-Competitive FDA Approval

Goodwin

Congress Adopts Biosimilar Related Provisions in the 2020 Appropriations Act

Goodwin on

In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars.  Under the BPCIA, approved NDAs for biological...more

McDermott Will & Emery

FTC Ratchets up Scrutiny on Pharmaceutical Deals

McDermott Will & Emery on

WHAT HAPPENED: • Recent developments indicate that pharmaceutical deals are attracting greater scrutiny from the Federal Trade Commission (FTC). • In September 2019, FTC Chairman Joseph Simons reportedly stated that the...more

Wilson Sonsini Goodrich & Rosati

2018 Life Sciences Securities Litigation Roundup

2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...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Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions.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

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

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

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