FDA approves first biosimilar of 2018: 3 things to know

Pfizer earned FDA approval for its drug Retacrit — a biosimilar version of the anemia therapy Epogen/Procrit — May 15.

Here are three things to know.

1. Like Amgen's Epogen and Johnson & Johnson's Procrit, Retacrit may now be used to treat anemia linked to chronic kidney disease, chemotherapy or the use of zidovudine in HIV patients. The FDA also approved the biosimilar for use before or after surgeries to control blood loss.

2. The FDA previously rejected Retacrit in 2017, citing concerns over a manufacturing facility Pfizer would potentially use to produce the drug.

3. Retacrit is the first biosimilar approved in 2018 and the third biosimilar approved from Pfizer's portfolio.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Articles We Think You'll Like

 

Featured Whitepapers

Featured Webinars