This article is more than 5 years old. Information may no longer be current.
What are biosimilars?
Click Here to Manage Email Alerts
Biosimilars are biological products that are considered comparable to an already FDA-approved biological product.
Biological products consist of a variety of natural resources — such as sugars, proteins, and nucleic acids or cells and tissues — with the ultimate goal of preventing and treating a variety of diseases and conditions.
Licensure of biosimilars was made possible through the 2009 Biologics Price Competition and Innovation Act, signed into law with the Affordable Care Act in 2010.
The FDA requires biosimilars to meet the same safety and efficacy standards as their reference products. However, minor alterations are allowed in clinically active components.
Although biosimilars are only approved for the same disease or condition as their reference product, a biosimilar may be approved for less than that of the reference product.
The FDA therefore recommends for physicians to carefully and fully review the prescribing information of the biosimilar product prior to prescribing it to patients. A pharmacist may only substitute an interchangeable product and not a biosimilar for the reference product without notice or approval from the health care provider.
Zarxio
The only biosimilar product approved by the FDA is filgrastim-sndz (Zarxio, Sandoz). Filgrastim-sndz is a biosimilar for filgrastim (Neupogen, Amgen), indicated for patients with cancer undergoing myelosuppressive chemotherapy or bone marrow transplantation; those with acute myeloid leukemia undergoing consolidation or induction therapy; those undergoing autologous peripheral blood progenitor cell collection and therapy; and patients diagnosed with severe chronic neutropenia.
The approval of filgrastim-sndz was based upon FDA review of data indicating the product is biosimilar to Neupogen. It is important to note that the FDA approved filgrastim-sndz as a biosimilar and not as an interchangeable product; therefore, it is not approved to be substituted without physician approval.
Common adverse events associated with filgrastim-sndz include aches in the bones or muscles and swelling or itch at the injection site. Other serious adverse events that may arise include serious allergic reactions, spleen rupture and shortness of breath.
Approval process
For any future biosimilar to be approved, the FDA requires a manufacturer’s application that must include data demonstrating the product is comparable to the reference product, animal studies demonstrating the toxicities, and clinical trials showing the safety, purity and efficacy for use in at least one medical condition for which the reference product is already approved for.
According to the FDA, the goal of this approval process is to demonstrate biosimilarity between the proposed product and the reference product, not for the independent establishment of safety and efficacy of the proposed biological product.
For more information:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm