FAQs

  • What Are Biologics?

    Biological products—biologics—have vastly improved the treatment of conditions such as rheumatoid arthritis, anemia, leukopenia, inflammatory bowel disease, psoriasis, and various forms of... Read more

  • What Are Biosimilars?

    A biosimilar is a biological product that is developed to be similar to an already FDA-approved biologic, known as the reference product. It can be tempting to think of a biosimilar as a... Read more

  • How Are Biosimilars Regulated?

    The European Medicines Agency (EMA) was the first body to develop an overarching framework for approving biosimilars. Biosimilars have been approved for use in the European Union since 2006; they... Read more

  • How Does a Manufacturer Demonstrate Biosimilarity?

    There is no single study that will demonstrate biosimilarity. The FDA uses a “totality of the evidence” approach to review applications for biosimilar products. Manufacturers must provide data... Read more

  • May a Biosimilar Be Used in Place of a Reference Product?

    Pharmacists are not permitted to automatically substitute a biosimilar for its reference product; they would need to contact the prescriber to approve the switch. Currently, the health care provider... Read more