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Cipla, Piramal Launch Sensipar Generics Amid Growing Antitrust Challenges to Amgen/Teva Settlement

 
• By Sue Sutter

Amgen seeks a preliminary injunction to halt US sales by Cipla and says it will take steps to stop Piramal’s sales; in its antitrust lawsuit, Cipla alleges Amgen paid to license Teva products under the companies’ patent settlement, which resulted in Teva pulling its generic off the market shortly after launch.

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Sensipar marketer Amgen Inc. and cinacalcet generic drug sponsors are engaged in a complicated series of launch and litigation moves that are creating uncertainty in the US market for the calcium-sensing receptor agonist and raising new antitrust questions in the process.

A federal judge in Delaware will hear oral argument April 2 on Amgen’s motion for a preliminary injunction to halt Cipla Ltd.'s sale of generic cinacalcet tablets

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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

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.