A biosimilar is a medicine that is highly similar, but not identical, to a biologic medicine (see definition below). They are also known as “follow-on biologics.”

  • Biosimilars are modeled after a biologic already approved for use. The active ingredient must closely resemble the active ingredient of the original biologic. This is different from a generic version of a chemical drug, as generics must be identical.
  • Biosimilars cost less than their biologic counterparts. This is because, while both biologics and biosimilars are made from living organisms, biosimilars are likely to have a less expensive and burdensome FDA approval process than the biologic on which a biosimilar is based.

A biologic is a drug made from a living organism and is used to treat certain chronic conditions. Biologics are often referred to as “reference products” or “innovator drugs.” Factor products are biologics.

  • Biologics are often large, complex molecules that are highly sensitive.
  • Biologics are often delivered by an infusion or injections.
  • Biologics are very expensive to produce – the manufacturing process is generally much more complex than that for chemical drugs.
  • The FDA approval process for biologics is arduous.

In 2010, the Affordable Care Act (ACA) established a new regulatory pathway for a class of drugs known as biosimilars. The new abbreviated regulatory pathway established by the ACA may enable patients to have access to more affordable biosimilar products in addition to the biologics that they are already using. Easier access to biosimilars also comes with risks to patient safety that requires evaluation. There are three issues surrounding biosimilars that are critical to the bleeding disorders community:

    • Approval Process
      • The approval process must take into account an assessment of immunogenicity and have robust clinical trials and post-market surveillance. The FDA must ensure that an approved biosimilar has “no clinically meaningful differences” between it and the reference drug, and is thus “interchangeable.”
    • Naming
      • Biosimilars must have names distinct from the reference biologic to eliminate confusion among providers and patients about which product is being taken and to allow for quick reporting of adverse events.
    • Substitution
      • Pharmacies and providers should not be able to automatically substitute a biosimilar for a biologic.

State Issues

Federal Issues



PGR_Biosimilars_IssueBrief_2016-02-03 Read our Biosimilars Issue Brief
Dear Addy_biosimilar Dear Addy-HFA’s Q&A advocacy column broke down what a biosimilar is, and how this issue affects the bleeding disorders community.
Patients for Biologics Safety and Access PBSA Logo Patients for Biologics Safety & Access (PBSA)-PBSA is a national coalition representing more than 20 patient advocacy organizations working to ensure that the voices and interests of patients are heard as the FDA considers approval of a new category of drugs known as biosimilars.
FDA Logo Food and Drug Administration- Biosimilars-The FDA is responsible for approving biosimilars and making the rules surrounding their approval and usage.
Biotechnology Industry Association BIO Logo Biotechnology Industry Association (BIO)-BIO is the largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations.
European Medicines Agency Logo European Medicines Agency-EMA is responsible for regulating pharmaceuticals in Europe, where up to 20 biosimilars are already in use.

Sign up for E-mails, Dateline Magazine, and other ways to stay connected.