Healthy Women Image

Alex Fulton

Alex Fulton has been working in the wellness field for more than 20 years. She has written extensively about integrative medicine, herbalism, supplements and other topics related to holistic health. Alex also focuses on issues related to women's health, from menstruation to menopause. She has collaborated with physicians, midwives and functional medicine practitioners to promote natural approaches to health care for women. She has a BA in English from the University of Wisconsin-Madison.

Full Bio
Biologics, Biosimilars and Generics: What’s the Difference?

Biologics, Biosimilars and Generics: What’s the Difference?

Understanding biologics vs. biosimilars vs. generic drugs

Your Care

Biologics, Biosimilars and Generics: What\u2019s the Difference? Infographic. Click image to view PDF

What are biologics?

A biologic is a medication made from living materials. These sources include:

  • Plant cells
  • Animal cells
  • Microorganisms such as bacteria and yeast

Biologics are used to treat many different health problems, including:

  • Diabetes
  • Arthritis
  • Multiple sclerosis
  • Psoriasis and other chronic skin diseases
  • Crohn’s disease, colitis and other chronic bowel diseases
  • Breast, lung and colon cancers

What are biosimilars?

Biosimilar medications are also biological drugs that are made from the same types of living materials as biologics, and used in the same way to treat some of the same health problems. They are designed to match an already approved biological drug.

Biologics vs. biosimilars

Biosimilars are very similar to the biologic they’re modeled after.

A biosimilar is based on a biologic, which is called the reference product.

Biologics are made from living materials, so they can’t be copied exactly in the way drugs made from chemicals can.

To get FDA approval, biosimilars must:

  • Work in the same way as the reference product
  • Work just as well as the reference product

Biosimilars are usually less expensive to develop than biologics, making them ultimately more affordable for patients.

What are generics?

A generic is a type of drug that contains the same chemicals as a brand name drug. Once a brand name drug’s chemical formula is no longer protected by a patent, other manufacturers can make their own “generic” version of this drug.

To be approved by the FDA, a generic must be the same as the brand name in:

  • Dosage form
  • Safety
  • Strength
  • Route of administration (oral, nasal, IV, etc.)
  • Quality
  • Performance
  • Intended use

Biosimilars vs. generics: Are they the same thing?



Copy of an approved medication



Proven to be safe



Proven to be effective



Similar to reference product


Exactly the same as reference product


Made from chemicals


Made from a natural/living source


Can a pharmacist substitute a biosimilar for a biologic?

If a biosimilar is interchangeable, a pharmacist can substitute it for a biologic without asking the prescribing healthcare provider.

If a biosimilar isn’t interchangeable, it can’t be substituted by the pharmacist without them first getting permission from the prescribing healthcare provider.*

*This can vary by state.

Using a biologic and wondering if a biosimilar might cost less but work just as well? Ask your healthcare provider.

This educational resource was created with support from Sandoz.

You might be interested in