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Competition Biosimilars

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY2025 Medicare Advantage and Part D Final Rule

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule,...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

Troutman Pepper

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

Troutman Pepper on

The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

Kilpatrick

10 Key Takeaways - Navigating Litigation Under the Biologics Price Competition and Innovation Act BPCIA

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On January 11, 2024, Kilpatrick Partner April Isaacson and Counsel Yifan Mao presented “Navigating Litigation Under the Biologics Price Competition and Innovation Act (BPCIA)” to entrepreneurs in the Chinese life science...more

Fish & Richardson

Biosimilars 2022 Year in Review

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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

Smart & Biggar

2022 mid-year highlights in Canadian life sciences IP and regulatory law

Smart & Biggar on

In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more

Proskauer - Life Sciences

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

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Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

MoFo Life Sciences

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

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Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more

Akin Gump Strauss Hauer & Feld LLP

President Biden’s ‘Promoting Competition’ Executive Order: Key Health Care Actions to Follow

As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more

Morgan Lewis - As Prescribed

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more

Proskauer - Life Sciences

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?

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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

White & Case LLP

What Does President Biden’s July 9, 2021 Executive Order on Competition Mean for the Pharma Industry?

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Citing concerns about growing consolidation, reduced competition, and increasing prices, President Biden issued on July 9, 2021 a sweeping Executive Order containing 72 initiatives to address competition concerns in a number...more

Goodwin

Biden Executive Order Calls for Heightened Antitrust Scrutiny

Goodwin on

On July 9, 2021, President Joe Biden announced a broad executive order (the “Order”) intended to boost what it characterizes as stagnant competition across the U.S. economy. The Order, among other things, encourages the...more

Goodwin

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

Goodwin on

On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more

Kilpatrick

Two Bipartisan Bills Aim to Encourage Competition in the Biopharma Industry

Kilpatrick on

Drug pricing and innovation are hot topics in Washington right now with several bills making their way through the legislative process, many in a bipartisan fashion. On April 23, 2021, two of these bills were signed into law...more

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

7th Circuit Hears Oral Arguments in Humira “Patent Thicket” Antitrust Case

On February 25, 2021, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc. (Case No. 20-2402), a case appealed from the U.S. District Court for the Northern...more

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

Boehringer Ingelheim Seeks to Redefine a Biosimilar’s “Strength”

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics...more

McDonnell Boehnen Hulbert & Berghoff LLP

An Analysis of a Failed Biosimilar Antitrust Class Action

On June 10th, Judge Manish S. Shah, U.S. District Court Judge for the Northern District of Illinois, dismissed (without prejudice) a class action lawsuit against AbbVie and AbbVie Biotechnology Ltd. by consumer groups, drug...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

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