The approval of Pfizer’s Retacrit marks the FDA’s first biosimilar approval of 2018.
Retacrit (epoetin alfa-epbx) is a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
“With Retacrit’s approval, the FDA is delivering on its promise to increase momentum around biosimilar approvals. Biosimilars are making great strides in the U.S., mostly from positive changes to policy and reimbursement,” says Rick Lozano, VP of Biosimilars & Integrated Business Development at AmerisourceBergen.
Lozano, though, is also careful to point out that while this approval is exciting, there are still challenges facing the biosimilar marking. However, he goes on to say that there are “incentives that are crucial for the success of biosimilars, like rebates currently reserved for biologics,” and “this latest approval is encouraging as it builds on the success and learnings of past launches.”
He also comments that manufacturers have gotten better at determining how to be competitive as the market changes, stating, “biosimilars need to be distributed in all channels to ensure adequate patient access, and providers need to be educated on the safety and efficacy of the product.”
Moving forward, Lozano believes that significant cost savings are possible if the FDA enacts policies that speed up the process of bringing biosimilars to market.
For more information, please visit: Retacrit.
(Source: The U.S. Food and Drug Administration)
Filed Under: Drug Discovery