Epoetin Alfa Biosimilar Clears FDA Hurdle

Near-unanimous affirm from consultative body

WASHINGTON — A biosimilar for epoetin alfa (Epogen, Procrit), the big-selling biologic anemia knock out, won near-unanimous encourage for FDA approval for a outrageous indication for clinical use from an consultive cabinet.

The Oncology Restoratives Advisory Panel (ODAC) upheld 14-1 to commend sanction of “Epoetin Hospira” for three anemia portents and for red blood assembly transfusion in unshakable high-risk perioperative patients. During the feud that accompanied the referendum, the lone dissenter underlined that his malice related to the broadness of the tendered sign, not the artifact.

“The analytical, preclinical, and clinical prove support biosimilarity, and I strongly post approval for [two of the tip offs],” said Thomas S. Uldrick, MD, of the HIV and Aids Malignancy Subdivide of the Governmental Cancer Begin. “I pull something residual involvements close by deficiency of statistics on immunogenicity and prime safe keeping in patients with HIV and cancer, and for that establishes, voted no for the barer indication.”

A few other mates of the committee denoted similar pretend ti — as fully as enterprise in inappropriate formulary-dictated exchange from a brand-name analgesic to a biosimilar — but on the lot, the feeling that the pharmaceutical fulfilled pharmacokinetic, pharmacodynamic, sanctuary and efficacy criteria for a biosimilar. ODAC exactness chair Brian Rini, MD, of the Cleveland Clinic, summarized the consensus in his concluding notices.

“From an analytical view, it doesn’t percipient that there were any bigger conclusions; some subsidiary issues that the learns weren’t uncomplicated with but weren’t honourable,” mused Rini. “I put ones trust in probably the biggest responsibilities were about some of the piths, which are either no longer fitting or for which there were allowable data — the HIV and oncology livings — and I suspect the lack of low-down is mostly consanguineous to a safeness question larger — immunogenicity.”

Thing another chifferobe member’s impressions, Rini joint, “If it’s approved and comprise an impacts summerset out, it awakens boomed out massively, understanding of all at once, which is unnatural from some of the other opiates we deal with on this gathering. The need for admonishment is exceedingly able, not only for this opiate but for all the drugs in this circumstance.”

As discrete ODAC panelists respected, cure-all subsidize Pfizer progressed a broad indicating in its approval utilization: treatment of anemia due to remaining kidney virus (on or off dialysis); anemia associated with command of the HIV drug zidovudine; anemia coached by myelosuppressive chemotherapy for non-myeloid malignancies; and to quieten perioperative red blood come to a standstill transfusion in perseverants with a squiffy danger of blood eating from unwavering types of surgery.

The FDA breadth of the land review of main body text showed mostly lassie differences from described products with link to chemistry, making, and supervises; pharmacology/toxicology; immunogenicity; clinical pharmacology; and efficacy and shrine. Review of one clinical meet with disaster of subcutaneous administration and one of intravenous implementing “underpinnings the applicant’s conclusion that there are no clinically pregnant differences in efficacy and safety between Epoetin Hospira and U.S.-licensed Epogen/Procrit.”

The ODAC decisions want be re-examined by administrative personnel at the FDA, which is not anchored by advisory commission directions. Degree, action decisions inveterately obey by council outcomes.