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Industry Insights

Clinical Insights

Read about advances and research in the field of cancer treatment and how these advances fit within the value-based care model. 

Featured article

Examining the FDA’s rigorous approval process for biosimilars

Following the approval of Zarxio (filgrastim-sndz) — the first biosimilar product approved by the Food and Drug Administration (FDA) for use in the U.S. — in March of last year, there has been much discussion about how biosimilars may potentially change how physicians treat specialty diseases and possibly lower the cost of care.

Many physicians have expressed concerns about the FDA’s biosimilar approval process and the safety and efficacy of these drugs. While these concerns are valid, the FDA requires the same types of rigorous tests used to approve biologic reference products for approving their biosimilar versions as well, and the same strict manufacturing guidelines are in place.

Dr. Nisha Pherwani, Clinical Director of Oncology for Cardinal Health, explains why physicians should feel confident about the FDA’s rigorous approval process for biosimilars in this article.

Understand the approval process