Pfizer’s biosimilar to blockbuster anemia meds Epogen and Procrit won the support of an FDA expert panel on Thursday, moving another step closer to a potential approval.
Independent experts backed the med by a 14-1 vote, signaling little doubt that the drug meets biosimilarity requirements for licensure. Indeed, ahead of the panel’s meeting, FDA reviewers called the Pfizer med “highly similar” to the reference product, epoetin alfa, sold by Amgen as Epogen and Johnson & Johnson under the Procrit brand name.
Pfizer picked up the biosim as part of its $16 billion Hospira buy. The New York drugmaker already has one approved biosimilar drug in Inflectra, a knockoff version of Johnson & Johnson’s Remicade.
The FDA doesn’t have to follow its expert panel recommendations, but it typically does. Amgen’s Epogen turned in $1.3 billion in sales last year, a 31% decline from the year prior and a decline that Amgen has attributed to competition and patients switching to the longer-acting Aranesp. The big biotech markets the med for anemia in chronic kidney disease patients.
J&J's Procrit sales also rang in above $1 billion. That med is sold for anemia stemming from cancer treatment.
Ahead of the panel meeting, FDA reviewers said there are “no clinically meaningful differences” between the Pfizer and Amgen products “in terms of the safety, purity and potency.” Pfizer is seeking an approval in each of the drug's four indications.
But even if Pfizer’s biosim is to ultimately win FDA approval, the product faces another barrier in an Amgen lawsuit aiming to block the launch.
Last year, Amgen sued Pfizer on grounds the New York drugmaker provided its marketing notice too early. That case is set to start in September.
Amgen is fighting just that issue in the Supreme Court, where it’s squared off against Novartis’ Sandoz in a case with huge implications for the budding biosim field. The companies are arguing whether it’s mandatory for biosim developers to participate in the “patent dance” ahead of a launch and exactly when they can provide official marketing notice.
Novartis' Sandoz unit is also preparing to submit its own Epogen biosim.