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US Off-Patent Legislation Could Save Over $1bn In Ten Years

Both Bipartisan Bills Were Introduced To The Senate Judiciary Committee Last Year

 
• By Urtė Fultinavičiūtė

If passed, the two bills favoring generics and biosimilar developers would not only result in federal savings but would also lead to earlier market entry for off-patent drugs.

Word BILLION made from small white letters on dollar background
• Source: Shutterstock

Two US bipartisan bills promoting fair off-patent competition and preventing sham petition filing could reduce governmental direct spending by over a billion dollars in the next decade, assuming both bills get enacted in the middle of fiscal year 2024, according to the Congressional Budget Office.

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More from Policy & Regulation

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.

French Body Welcomes Call For Greater Uptake

 
• By Dave Wallace

French generics and biosimilar body Gemme has welcomed a call from the country’s audit court to improve uptake for off-patent medicines.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

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