U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Therapeutic Biologics Applications (BLA)
  7. Biosimilars
  8. Biosimilars Drop-In Articles
  1. Biosimilars

Biosimilars Drop-In Articles

Newsletter Article: Prescribers

Biosimilars may be a treatment option for your patient—learn the facts

Biological products have revolutionized treatments for many serious and life-threatening conditions, but it can be a difficult choice for health care professionals when the right treatment for your patient is a high-cost biological product. With the cost of prescription drugs an ongoing concern in health care, the emergence of biosimilars is offering more treatment options for patients, as well as much-awaited market competition that can potentially reduce costs for patients with serious medical conditions.

As of October 2017, the U.S. Food and Drug Administration (FDA) has approved seven biosimilars—and some are already on the market. These products can help patients with a wide range of conditions, including autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, and ulcerative colitis. They also help certain patients with various types of cancer, including breast cancer, metastatic colorectal cancer, non-squamous non-small cell lung cancer, and glioblastoma.

Patients are hearing about biosimilars—and asking questions. As more biosimilars are approved in the United States, FDA wants health care providers to understand what these products are and how they can be prescribed to help patients. The agency has developed educational materials to help health care providers gain a better understanding of these important new types of medication. These resources:

  • Provide the basic definitions for biological drugs, reference products, biosimilars, interchangeable products, and other terms;
  • Facilitate understanding of the relationship between biosimilars and the biological products they were compared to, known as reference products;
  • Describe the rigorous standards any biosimilar must meet prior to approval and explain how the FDA approval pathway works for these products; and
  • Provide easily accessible information about the data and information FDA reviews to determine biosimilarity and how to find more resources.

The site also highlights information about an important reference for biosimilars known as the “Purple Book.” This reference can help you easily identify which biological reference products currently have one or more FDA-approved biosimilar or interchangeable products.

An increase in market competition may lead to reduced costs for both patients and our health care system. Similar to how the introduction of generic drugs in the United States has led to significant cost savings, biosimilars have the potential to save our health care system billions of dollars over the coming years, as well as to improve public health. A better understanding of biosimilars can help prescribers and their patients maximize the benefits of these products.

Newsletter Article: Patients

Biosimilars are new in the U.S.—learn more about these treatment options

If you’re using an injectable prescription drug, it could be a biological product. If so, a new kind of biological product, called a biosimilar, may be an option for you.

A biosimilar approved by the U.S. Food and Drug Administration (FDA) is highly similar to and has no clinically meaningful differences in terms of safety and effectiveness from an already FDA-approved biological product, which is known as the reference product. Biosimilars are not the same as generic drugs—but like generics, biosimilars may offer more affordable treatment options to patients.

Biosimilars can help patients with a wide range of conditions, including autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, and ulcerative colitis. They also help patients with certain types of colorectal, lung, breast, and other types of cancer.

As of October 2017, FDA has approved seven biosimilars, and some are already on the market. As more biosimilars are approved, FDA wants health care professionals to understand what these products are and how biosimilars can help patients in need. FDA has developed educational materials to help doctors and their patients gain a better understanding of these important new types of medication. These resources:

  • Provide the basic definitions of terms to help people understand the relationship between biosimilars and their reference products;
  • Describe the rigorous standards any biosimilar must meet prior to approval, and explain how the FDA approval pathway works for these products; and
  • Provide easily accessible information about the data and information FDA reviews to determine biosimilarity, and how to find more resources.

The site also highlights information about an important reference for biosimilars known as the “Purple Book,” an online resource that health care professionals and patients can use to locate information about approved biological products. If you want to know if there is a biosimilar approved for the biological product you are currently using, you or your doctor can look it up in the Purple Book.

An increase in market competition for biological products may lead to reduced costs for both patients and our health care system. Similar to how the introduction of generic drugs in the United States has led to significant cost savings, biosimilars have the potential to save our health care systems billions of dollars over the coming years, as well as to improve public health. A better understanding of biosimilars can help you and your doctor maximize the benefits of these products.

 
Back to Top