News & Analysis as of

Federal Trade Commission (FTC) Biosimilars Food and Drug Administration (FDA)

Hogan Lovells

FTC continues to focus on competition in pharmaceutical markets, supports FDA guidance on biosimilars

Hogan Lovells on

On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Venable LLP

FTC Submits Comment Supporting Proposed FDA Guidance Revising Switching Studies for Biosimilar Interchangeability

Venable LLP on

On August 20, 2024, the Federal Trade Commission (FTC) submitted a comment supporting the FDA’s June 2024 draft guidance “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the...more

Sheppard Mullin Richter & Hampton LLP

FTC's Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Mintz - Health Care Viewpoints

Ushering in a New Era: FDA Approves First Interchangeable Biosimilar

Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee...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

Mintz - Health Care Viewpoints

Biden Administration Takes Aim at Rising Drug Prices through its Executive Order on Promoting Competition

On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more

Goodwin

President Biden Issues Executive Order Including Provisions To Promote Generic Drug and Biosimilar Competition in the American...

Goodwin on

On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2020

Goodwin on

As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory,...more

American Conference Institute (ACI)

[Virtual Event] 11th Summit on Biosimilars & Innovator Biologics - September 23rd - 24th, 7:45 am - 5:00 pm ET

This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more

Goodwin

FDA/FTC Joint Workshop on a Competitive Marketplace for Biosimilars – Comments from Stakeholders

Goodwin on

As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their...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

White & Case LLP

FTC and FDA Announce Plans to Combat Anticompetitive Practices in the "Biologic Marketplace"

White & Case LLP on

On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more

King & Spalding

FDA Releases Draft Guidance on Promotion of Biological Reference and Biosimilar Products

King & Spalding on

Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more

Fish & Richardson

Increasing Competition in the Biologic Market Through Truthful Advertising

Fish & Richardson on

This past week, FTC and FDA have taken further steps to encourage robust biosimilar competition in 2020 and beyond, this time with a particular focus on truthful and non-misleading advertising....more

Bergeson & Campbell, P.C.

FDA/FTC To Host Public Workshop On Biosimilars’ Competitive Market

On March 9, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), will host a public workshop titled “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” ...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

McDermott Will & Emery

Anticompetitive Conduct in Biologics – An Enforcement Priority with FTC and FDA

Today the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for...more

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