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Biosimilar Litigation Settlement Score Card: Genentech-Pfizer Herceptin Agreement Is 10th Deal

 
• By Brenda Sandburg

Genentech inks second settlement of trastuzumab biosimilar litigation; suits ongoing against Amgen, Celltrion/Teva, and Samsung with joint claim construction proceedings.

Courthouse Inscription

Genentech Inc. and Pfizer Inc. entered into a settlement agreement to end litigation over Pfizer's biosimilar to Herceptin (trastuzumab), two months before the user fee goal date for US FDA action on Pfizer's product.

The companies disclosed the agreement in a Dec. 4 filing with the US District Court for the District of...

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More from United States

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US FDA Rare Disease Hub RISEs After Slow Start

 
• By Michael McCaughan

The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.

More from North America

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.