Hospira, Inc. HSP presented data from two studies on a proposed biosimilar, Retacrit (Epoetin Hospira), at the National Kidney Foundation spring meeting. The drug is a proposed biosimilar to Amgen Inc.’s AMGN Epogen (epoetin alfa) and Janssen’s Procrit (epoetin alfa). Janssen is a division of Johnson & Johnson JNJ.
Both the randomized, open-label, active-controlled studies compared the pharmacokinetic and pharmacodynamic equivalence of Retacrit to Epogen administered in healthy volunteers by subcutaneous injection. While one study evaluated a single dose of 100 units/kg, the other study evaluated multiple doses of 100 units/kg administered three times per week for four weeks.
Both single and multiple-dose pharmacokinetic and pharmacodynamic studies support the biosimilar application for Retacrit in the U.S.
We note that in February the FDA accepted Hospira’s Biologics License Application (BLA), looking to get Retacrit approved in the U.S.
Hospira stated that on Dec 16, 2014, it had submitted the BLA, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009.
Epogen is indicated to treat a lower-than-normal number of red blood cells caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions. Procrit is also used to treat a lower-than-normal number of red blood cells if it is caused by chronic kidney disease and certain other indications.
Hospira has a lucrative biosimilar pipeline, which is potentially worth multi-billion dollars. As per company sources, the worldwide biosimilars market is expected to be worth approximately $20 billion by 2020.
Earlier this month, the FDA approved the first biosimilar Zarxio (filgrastim-sndz) from Sandoz. Zarxio is a biosimilar to Amgen’s Neupogen (filgrastim).
Hospira is set to be acquired by Pfizer Inc. PFE. The deal is expected to close in the second half of 2015. The transaction is valued at approximately $17 billion or $90 per share.
Hospira carries a Zacks Rank #2 (Buy). Another well-ranked stock in the health care space is Alnylam Pharmaceuticals, Inc. ALNY holding the same Zacks Rank as Hospira.