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

What are biologicals?

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

• Vegetables 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 intestinal diseases.

• Breast, lung and colon cancers

What are biosimilars?

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

Biologics versus biosimilars

Biosimilars are very similar to the biological product they are modeled after.

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

Biological products are made from living materials, so they cannot be copied exactly the way medicines made from chemicals can.

To obtain FDA approval, biosimilars must:

• It works in the same way as the reference product.

• Works as well as the reference product.

Biosimilars are typically less expensive to develop than biologics, ultimately making them 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 the chemical formula of a brand-name drug 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

• Security

• Strength

• Route of administration (oral, nasal, IV, etc.)

• Quality

• Performance

• Expected use

Biosimilars versus generics: are they the same?

Can a pharmacist substitute a biologic for a biosimilar?

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

If a biosimilar is not interchangeable, the pharmacist cannot substitute it without first obtaining permission from the prescribing healthcare provider.*

*This may vary by state.

Are you using a biologic and wondering if a biosimilar could cost less but work just as well? Ask your healthcare provider.

This educational resource was created with the support of Sandoz.