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AAM Calls Out Threat Of Consolidation Among Purchasers

Letter To Authorities Accuses Buying Groups And PBMs Of Anticompetitive Activities

 
• By Chloe Kent

Drug buying groups and pharmacy benefit managers are leaving generic drug producers unable to compete even when they have viable products due to concentration of buyer power, the Association for Accessible Medicines has highlighted.

Monopsony text over $100 bills
AAM has accused drug buying groups of creating a monopsony on generics • Source: Alamy

The Association for Accessible Medicines has implored the US Federal Trade Commission and the antitrust division of the Department of Justice to address anticompetitive challenges in the generics industry, in a response to the agencies’ 18 January request for information on how they can modernize enforcement of antitrust laws regarding mergers. (Also see "Merger Enforcement: FTC And Justice Department Casting Wide Net In Considering Changes" - Pink Sheet, 19 January, 2022.)

These problems have been caused by monopsony power of drug buying groups purchasing generic drugs, as well as consolidation, integration and concentration of market power by pharmacy benefit managers

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US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

More from Policy & Regulation

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.