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Policy and Regulation

Regulation Explore this Topic

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Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

FDA Drug Approval Standards

Sandoz: Big Cap Biosimilar Rivals Lack Clarity On Commitment

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Biosimilars Strategy

GDUFA Research Impacting Generic Development, ANDA Approvals

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

Generic Drugs Research & Development
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Pricing Strategies; Reimbursement Explore this Topic

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US Patients Continue To Overpay For Off-Patent Drugs Despite $373bn In Savings

The US Association for Accessible Medicines’ annual report into generic and biosimilar savings has documented another year of increased cost savings thanks to off-patent drugs, but says some patients are still overpaying for their generic medicines. 

Generic Drugs Biosimilars

Pharma Readies For Price Caps On Glargine, Teneligliptin, Lenalidomide In India

India’s national list of essential medicines 2022 features 34 additions, including insulin glargine, teneligliptin, lenalidomide, bedaquiline and montelukast, with price control expected to follow on these drugs.

Policy India

Akorn Pays Out $7.9m In Medicare Fraudulent Billing Case

Akorn has agreed to pay out $7.9m to settle allegations that it deliberately sold three generic drugs as prescription-only when they should have been classed as over-the-counter, in a deal with the US Department of Justice. The mislabeling led Medicare Part D to pay out for the drugs for around a year despite the products not being eligible for Medicare coverage.

Legal Issues United States
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Intellectual Property Explore this Topic

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US Federal Circuit Will Not Stand In Way Of Gilenya Generics

ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.

Generic Drugs Legal Issues

Pfizer Overcomes Attempt To Block Lexiscan ANDA

Injunctive relief has been provided against Hospira’s regadenoson ANDA product only until early October, allowing the US-based generics sponsor to close in on a potential launch.

Generic Drugs Legal Issues

Viatris Loses US Challenge To Januvia And Janumet Patents

Viatris’ attempts to deliver US generic versions of sitagliptin and sitagliptin/metformin ahead of patent expiry has failed for now, with an unfavorable judgment from a district court in West Virginia. More than 20 ANDA sponsors have opted to settle litigation with originator Merck.

Generic Drugs Legal Issues
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Market Intelligence Explore this Topic

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What Aspects Will Give Humira Biosimilars The Edge In 2023?

With multiple Humira biosimilars slated for launch in the US next year, some simultaneously, a Vizient survey provides some insights into what could be the most important differentiating aspects. Generics Bulletin speaks to Steven Lucio, Vizient senior principal of pharmacy solutions, about the findings.

Biosimilars Market Intelligence

US Patients Continue To Overpay For Off-Patent Drugs Despite $373bn In Savings

The US Association for Accessible Medicines’ annual report into generic and biosimilar savings has documented another year of increased cost savings thanks to off-patent drugs, but says some patients are still overpaying for their generic medicines. 

Generic Drugs Biosimilars

Aripiprazole Leads A Slew Of UK Price Rises In A Dynamic August

Aripiprazole led the steepest UK generic price rises in August 2022, a hugely dynamic month that saw treble-digit percentage price increases for a number of molecules, according to the latest figures from WaveData.

Market Intelligence Pricing Strategies
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