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Sandoz’s Biosimilar Data-Bridging Plans For Zarxio Faced FDA Doubts

 
• By Sue Sutter

FDA 'strongly encouraged' Sandoz to conduct three-way clinical PK/PD study comparing its Zarxio biosimilar to the EU- and U.S.-approved versions of Amgen’s Neupogen; however, the firm succeeded in using only analytical data to justify relevance of studies using the European reference product.

Sandoz Inc.’s success at building an analytical bridge to foreign comparator data for its biosimilar Zarxio (filgrastim-sndz) may prove to be the exception rather than the rule for biosimilar development programs conducted with non-U.S. reference products.

The March 6 approval of Zarxio, a biosimilar to Amgen Inc.’s granulocyte colony-stimulating factor Neupogen (filgrastim), showed it is possible for a biosimilar applicant to successfully bridge to data...

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More from United States

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

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Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

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Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

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More from North America

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.