Pfizer: Epogen biosimilar denied approval.
(CercleFinance.com) - Pfizer said late on Thursday that US health regulators had denied approval to the company's biologics license application (BLA) for its proposed Epogen biosimilar.
The US biopharmaceutical firm says the complete response letter from the Food and Drug Administration (FDA) followed a routine agency inspection of a company's facility in McPherson, Kansas in 2016.
In a press release, Pfizer says it is committed to making this important treatment option available to patients and physicians "as quickly as possible."
Amgen's Epogen is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The US biopharmaceutical firm says the complete response letter from the Food and Drug Administration (FDA) followed a routine agency inspection of a company's facility in McPherson, Kansas in 2016.
In a press release, Pfizer says it is committed to making this important treatment option available to patients and physicians "as quickly as possible."
Amgen's Epogen is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney disease in patients on dialysis.
Copyright (c) 2017 CercleFinance.com. All rights reserved.