What are biosimilar products?
Biosimilars are a type of biological product that is licensed (approved) by the FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product) and have been shown to have no clinically meaningful differences from the reference product. Minor differences in clinically inactive components are allowed. But there must be no clinically meaningful differences between the biosimilar and the reference product it was compared to in terms of the safety, purity, and potency of the product
Biological products are made from a variety of natural sources and, like drugs, biological products are used to either treat or cure diseases and medical conditions, prevent diseases, or diagnose diseases. Biological products can be made of sugars, proteins, nucleic acids, complex combinations of these substances, or may be living entities such as cells and tissues.
What are interchangeable products?
Interchangeable products are both biosimilar to an FDA-approved reference product, and can be expected to produce the same clinical result as the reference product in any given patient. An interchangeable product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
In addition, for a biological product that is administered more than once to an individual, the risk in terms of safety or efficacy of alternating or switching between the biological product and the reference product will not be greater than the risk of using the reference product without alternating or switching.
Prescribing biosimilars and interchangeables:
Health care professionals can prescribe biosimilar and interchangeable products just as they would prescribe other medications- by writing the proprietary name or nonproprietary name on the prescription.
A biosimilar can be approved only for those indications and condition(s) of use previously approved for the reference product, but a biosimilar can be approved for fewer than all the indications and condition(s) of use approved for the reference product. Therefore, it is important for health care professionals to review the product labeling (prescribing information) to determine which conditions of use and routes of administration the biosimilar was approved for.
Because interchangeable products have met additional criteria for approval, they may be substituted at the pharmacy without the intervention of a healthcare provider.
Currently, there is only one biosimilar approved for use in the U.S. - Zarxio (filgrastim-sndz), which is biosimilar to Neupogen (filgrastim).
How are biosimilars and interchangeables approved?
The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amended the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed (approved) biological product. This pathway is provided in the part of the Affordable Care Act known as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
What data does the FDA review to determine biosimilarity and interchangeability?
The manufacturer’s application for a biosimilar or interchangeable biological product must include, among other things, information demonstrating biosimilarity based upon data from:
- Analytical studies demonstrating that the biological product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components;
- Animal studies (including the assessment of toxicity); and
- A clinical study or studies (including the assessment of immunogenicity and pharmacokinetics (PK) or pharmacodynamics (PD)) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and for which licensure is sought for the biosimilar product.
An application for an interchangeable biological product also must include data or information to show that the proposed interchangeable biological product is expected to produce the same clinical result as the reference product in any given patient. In addition, for a product that will be administered more than once to an individual (as many biological products are), the application must include information that demonstrates that the risk in terms of safety or diminished effectiveness of alternating or switching between use of the proposed interchangeable product and the reference product is not greater than the risk of using the reference product without alternating or switching.
The goal of this approval pathway is to demonstrate biosimilarity or interchangeability between the proposed product and a reference product, not to independently establish safety and effectiveness of the proposed product.
Nonproprietary Naming of Biological Products Guidance for Industry(PDF - 111KB) Notice of Availability: Guidance: Nonproprietary Naming of Biological Products Proposed Rule: Designation of Official Names and Proper Names for Certain Biological Products
- FDA Voice Blog: Naming and Biological Products
- FDA News Release: FDA approves first biosimilar product Zarxio
Visit Drugs@FDA for more information about Zarxio (filgrastim-sndz) Implementation of the Biologics Price Competition and Innovation Act of 2009 Sections 7001-7003 (Biologics Price Competition and Innovation Act of 2009) of the Patient Protection and Affordable Care Act (Public Law No. 111-148)(PDF - 122KB) Biosimilars
Resources for You
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations Biosimilars FDA Basics Webinar, June 17, 2013: Biological Products: Part 1 FDA Basics Webinar August 19, 2013: Biological Products, Part 2: Biosimilar Biological Products