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Inflectra Launch Prep Continues Post-Deadline, Pfizer Says

 
• By Derrick Gingery

The 180-day notification period has passed for biosimilar of Celltrion's Remicade, but Pfizer seems to be aiming for an at-risk launch sometime this year.

Preparations for Pfizer Inc.'s launch of Celltrion Inc.'s Remicade biosimilar in the US continue, although are not ready for execution yet.

Pfizer told the Pink Sheet Oct. 6 that it still plans to launch Inflectra (infliximab-dyyb) this year, even though the...

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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
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Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
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More from Biosimilars & Generics

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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

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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.

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