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Pfizer’s Retacrit Finally Clears US FDA, But Biosimilar’s Launch Date Is Still Unclear

 
• By Sue Sutter

First biosimilar of Epogen/Procrit might launch this year, but timing of market entry will depend on many factors, including ongoing patent litigation with Amgen in Delaware federal court.

FDA Approved typed words on a vintage typewriter

With US FDA approval finally in hand, Pfizer Inc. is working toward launching Retacrit (epoetin alfa-epbx), its biosimilar to Amgen Inc.’s Epogen/Johnson & Johnson’s Procrit (epoetin alfa), this year.

Pfizer is “moving ahead with the preparation of our launch plans for 2018,” although launch timing “will ultimately depend on a number of factors,” a company spokesman told the Pink...

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• By Vibha Sharma

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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.

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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.

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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.