On November 13, Pfizer began marketing its biosimilar version of epoetin alfa. Pfizer launches Retacrit® at a 33.5% discount to Amgen’s reference product Epogen®. Retacrit was originally developed by Hospira, which Pfizer acquired in 2015. Retacrit was one of the first biosimilars approved in the EU. It had a long journey to reaching the market in … Continue reading Pfizer Launches Retacrit, First Biosimilar Version of Epogen and Procrit
Tag: Retacrit
FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further
When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation. The FDA has been a bit fuzzy … Continue reading FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further
Convincing Two Main Providers the Key to Pfizer’s Retacrit® Success
An unusual market situation awaits Pfizer’s new biosimilar epoetin, one that few approved medications has to face. Not only does Retacrit® need to pass muster with payers like health plans and insurers, which we assume it will, but Retacrit will need to be accepted by the two 800-pound gorillas of the kidney dialysis field as … Continue reading Convincing Two Main Providers the Key to Pfizer’s Retacrit® Success
Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
It has taken a long time, but Pfizer finally earned approval from the U.S. Food and Drug Administration (FDA) on the first biosimilar version of Epogen®. The drug, Retacrit® (epoetin alfa-epbx), had originally been submitted for approval in December 2014. Its much stalled road to approval is finally at an end. After an initial rejection, … Continue reading Pfizer Gets Green Light From the FDA on Epogen® Biosimilar
FDA Stuns With Rejection of Pfizer’s Retacrit
Following a 14-1 vote by its Oncology Drug Advisory Committee last month to recommend approval for Pfizer’s biosimilar version of Epogen®, the Food and Drug Administration (FDA) on June 22 sent the drug maker a complete response letter outlining its decision to reject the product.
Pfizer’s Epogen® Biosimilar Gets FDA Advisory Committee Backing
According to the FDA’s staffers’ summary released ahead of the May 25th Oncology Advisory Committee review, Retacrit fulfilled the requirements for biosimilarity. Today, the Advisory Committee added further support to this conclusion by voting 14-1 to recommend approval for all extrapolated indications, despite some safety concerns expressed by committee members.