Third time lucky for Pfizer's third biosimilar

16 May 2018

US pharma giant Pfizer (NYSE: PFE) has advanced its number of approved biosimilar medicines in the USA to three.

Gaining this latest US Food and Drug Adminiatration approval, a copy of Epogen/Procrit (epoetin alfa), has not been easy, with Pfizer twice receiving a Complete Response Letter (CRL) ffrom the FDA in relation to the candidate. It is the first and only biosimilar erythropoiesis-stimulating agent to be approved in the USA.

The original drug is marketed by Amgen (Nasdaq: AMGN) and Johnson & Johnson (NYSE: JNJ), and had sales last year of around $1.8 billion.

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