Biofármacos, biosimilares y genéricos: ¿Cuál es la diferencia?

Obesity is defined clinically as a body mass index (BMI) of 30 or more. But managing this medical condition is about much more than a number on a scale.

BMI is not everything

BMI can be used as a screening tool, but it does not tell the full story about an individual’s health. Talk to a healthcare provider if you have questions about your BMI.

Did you know?

Although healthy eating and physical activity are important for managing or losing weight, some people may need additional tools.

What are biopharmaceuticals?

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

  • Vegetables cells
  • animal cells
  • Stories of microorganisms such as bacteria and fungi.

Biopharmaceuticals are used to treat many medical problems, including:

  • diabetes
  • arthritis
  • multiple sclerosis
  • Psoriasis and other chronic skin disorders
  • Crohn’s disease, colitis and other chronic intestinal disorders.
  • Breast, lung and colon cancers

What are biosimilars?

Biosimilar drugs are also biological drugs that are prepared from the same type of living materials as biopharmaceuticals and are used in the same way to treat some of the same medical problems. They were designed as equivalents of already approved biopharmaceuticals.

Biopharmaceuticals versus biosimilars

Biosimilars are very similar to the biopharmaceuticals on which their design was based.

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

Biopharmaceuticals are made from living materials, so they cannot be copied in exactly the same way as drugs made from chemicals.

To obtain FDA approval, biosimilars must:

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

The development of biosimilars is usually less expensive than that of biopharmaceuticals, which ultimately makes them more affordable for patients.

What are generic drugs?

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

To receive FDA approval, a generic drug must be the same as the brand name drug in:

  • The dosage form
  • safety
  • Concentration
  • The route of administration (oral, nasal, intravenous, etc.)
  • The quality
  • Performance
  • Intended use

Biosimilars vs. Generics: Are they the same?



Copy of an approved medication



Proven safety



Demonstrated effectiveness



Similar to the reference product


Exactly the same as the reference product.


Prepared from chemicals.


Prepared from a natural or living source.


Can a pharmacist substitute a biodrug with a biosimilar?

If a biosimilar can be used as a replacement, a pharmacist could use it instead of a biopharmaceutical without having to ask the healthcare provider who wrote the prescription.

If a biosimilar cannot be used as a replacement, the pharmacist may not use it as a replacement without first obtaining authorization from the healthcare provider who issued the prescription.*

*This may vary depending on the state.

Are you using a biopharmaceutical and wondering if a lower-value biosimilar works as well? Ask your healthcare provider.

This educational resource was prepared with the support of Sandoz.

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