News & Analysis as of

Competition Pharmaceutical Industry

Sheppard Mullin Richter & Hampton LLP

DOJ and FTC Host Second Session on Structural and Regulatory Impediments to Drug Competition

On July 24, 2025, the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) convened the second of three public listening sessions aimed at identifying barriers to drug price competition in the U.S....more

Troutman Pepper Locke

Second FTC and DOJ Listening Session Focuses on Formulary and Benefit Practices and Regulatory Abuse in the Pharmaceutical...

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On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more

Dacheng

China's Inaugural Merger Control Litigation: Tobishi v. SAMR and Its Practical Impact

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Since the Anti-Monopoly Law came into effect in 2008, China has established a merger control regime now administered by the State Administration for Market Regulation (SAMR). Transactions that meet the notification...more

Jenner & Block

A Secured Reversal of Preliminary Injunction in High-Stakes Pharmaceutical Battle

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In a significant victory for pharmaceutical competition and access to generic drugs, Jenner & Block secured a key litigation win on behalf of client MSN Pharmaceuticals. A federal judge denied a pharmaceutical company’s...more

A&O Shearman

European Commission fines Alchem in first cartel case involving a pharmaceutical API

A&O Shearman on

On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more

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

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

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

Morrison & Foerster LLP

Trump Antitrust Enforcers Take Aim at High Drug Costs, With Uncertain Path Forward

Just before Americans celebrated the Fourth of July, on June 30, 2025, antitrust enforcers from both the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) hosted the first of two listening...more

Goodwin

DOJ and FTC Host ‘Listening Sessions’ on Competition Issues in the Pharmaceutical Industry

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In two recent public panels, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted the first of three joint listening sessions mandated by Executive Order No. 14273, Lowering Drug Prices by Once Again...more

Dacheng

SAMR Publishes Official Review on China’s Antitrust Enforcement in 2024: Key Developments and Takeaways

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On June 7, 2025, China’s State Administration for Market Regulation (SAMR) released the 2024 Annual Report on Antitrust Enforcement (“Report”), providing a comprehensive overview of key legislative developments, enforcement...more

Haug Partners LLP

Regeneron Pharmaceuticals, Inc. v. Amgen Inc.: Jury Finds Rebate Offers on Bundled Drugs in Exchange for Exclusive Formulary...

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On May 15, 2025, a federal jury in Delaware district court determined that Defendant Amgen Inc. (“Amgen”) violated antitrust and tort laws, and awarded $406.8 million in damages to Plaintiff Regeneron Pharmaceuticals, Inc....more

Rivkin Radler LLP

Cigna Sues Bristol Myers Squibb Alleging Scheme to Block Generic Drug

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Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a...more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Smart & Biggar

Update on biosimilars in Canada – June 2025

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This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more

Epstein Becker & Green

Agencies’ Listening Sessions to Focus on Lowering Drug Prices Through Competition

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The Federal Trade Commission (FTC) and the Antitrust Division of the U.S. Department of Justice (DOJ), along with the U.S. Department of Commerce and the U.S. Department of Health and Human Services (collectively, “the...more

Dacheng

China Monthly Antitrust Update: June 2025

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This monthly report outlines key developments in China’s antitrust sector for June. The following events merit special attention: SAMR Seeks Comments on Provisions for Curbing Acts of Abusing Administrative Power to Eliminate...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Dacheng

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

Polsinelli

Orange Book Listings: Republican Led FTC Picks Up Where Democrat Led FTC Left Off

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Key Takeaways - The Federal Trade Commission (FTC), now under Republican leadership, has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive...more

Troutman Pepper Locke

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

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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

Epstein Becker & Green

FTC and DOJ Direct Agency Heads to Identify Anticompetitive Regulations for Elimination—Including in Health Care

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President Trump’s Executive Order No. 14267, “Reducing Anti-Competitive Regulatory Barriers” (“EO 14267”), requires agency heads to provide by June 18, 2025, a list of anticompetitive regulations to the Federal Trade...more

Ropes & Gray LLP

[Podcast] Non-binding Guidance | Talkin’ Trade: Trends in False Advertising and Related Competitor Disputes Involving...

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On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner...more

Troutman Pepper Locke

Illinois and Minnesota AGs Join FTC’s Lawsuit Against Private Equity Firm

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Illinois Attorney General (AG) Kwame Raoul and Minnesota AG Keith Ellison have joined the Federal Trade Commission (FTC) in a lawsuit to block the acquisition of Surmodics Inc. by GTCR BC Holdings LLC, two major manufacturers...more

Morgan Lewis

China’s First Antitrust Enforcement Case Targeting Individual Liability: Strategic Guidance for Multinational Corporations

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The Administration for Market Regulation of Shanghai recently finalized penalties totaling RMB 223 million (approx. $31 million) against three pharmaceutical companies for colluding to fix prices and divide markets for...more

Dacheng

China’s First Court Ruling on Merger Control Upholds Conditional Clearance of Below-Threshold Deal

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In March 2025, the Beijing Intellectual Property Court issued a landmark ruling—the first case in which a filing party challenged a merger decision by the State Administration for Market Regulation (“SAMR”) through judicial...more

Kerr Russell

Michigan AG Alleges Anticompetitive Agreement Between Pharmacy Benefit Managers

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Michigan Attorney General Dana Nessel sued Express Scripts Inc. and Prime Therapeutics LLC, two pharmacy benefit managers (PBMs), in the U.S. District Court for the Eastern District of Michigan on Monday, April 28, 2025....more

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