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Half Of 1st Approved Generics Do Not Launch Due To Part D Formulary Obstacles, AAM Says

 
• By Brenda Sandburg

Medicare Part D program should place generics on tiers separate from brand drugs and create a dedicated tier for specialty generics and biosimilars, AAM advocates in white paper.

Formulary
AAM Advocates Speciality Formularly Tier To Differentiate Generics And Biosimilars

The Association for Accessible Medicines has gathered new data to bolster its argument that Medicare Part D plans should place generics on different formulary tiers than higher-priced brand drugs. It cites recent findings that fewer than half of first generics approved by the US Food and Drug Administration since 2016 are commercially available and of these, only about half were included on Part D formularies.

AAM released a white paper, "Access Denied: Why New Generics Are Not Reaching America's Seniors," on 23 September. It reports that first generics (the first competitor to a brand)...

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

More from Biosimilars & Generics

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

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.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.