Understanding
Biosimilars

WHAT IS A BIOLOGIC?

A biologic is a medicine made from a living organism or its products and is used for disease prevention, diagnosis, or treatment.

WHAT IS A BIOSIMILAR?

Biosimilars are biologic medicines that are highly similar to and have no clinically meaningful differences from an already approved biologic known as the reference medicine.

Reference medicines are existing medicines or treatments that are already available and approved, against which a biosimilar is compared.

All FDA-approved biosimilars are extensively evaluated to ensure that patients can rely on their efficacy, safety, and quality.

WHAT IS THE DIFFERENCE BETWEEN A BIOSIMILAR AND A GENERIC DRUG?

There are key differences between a biosimilar and a generic drug.

Generic drugs’ active ingredients match those used in brand name drugs while biosimilars must demonstrate that the biosimilar is highly similar* with no clinically meaningful differences in both safety and effectiveness.

*“Highly similar” means there may be a slight difference between a reference product and a biosimilar product in clinically inactive components (parts that do not meaningfully impact important product features such as safety or efficacy) - this is acceptable for FDA approval.

What is BYOOVIZTM (ranibizumab-nuna)?

BYOOVIZ is a prescription medicine for the treatment of patients with:

  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Myopic Choroidal Neovascularization (mCNV)

IMPORTANT SAFETY INFORMATION

Who should not use BYOOVIZTM (ranibizumab-nuna)?

  • You should not use BYOOVIZ if you have an infection in or around the eye or are allergic
    to BYOOVIZ or any of its ingredients

What is the most important information I should know about BYOOVIZ?

BYOOVIZ can cause serious side effects, including:

  • Detached retinas and serious eye infections. If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your healthcare provider right away
  • Increased eye pressure. Your healthcare provider should check your eye pressure and eye health before and after your BYOOVIZ injection
  • Heart attacks or strokes. There is a potential risk of serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes

    • Call your healthcare provider right away if you have any of the symptoms listed above.

What are the possible side effects of BYOOVIZ?

BYOOVIZ can cause serious side effects, including:

See above “What is the most important information I should know about BYOOVIZ?”

The most common side effects of BYOOVIZ include:

  • Increased redness in the white of the eye
  • Eye pain
  • Small specks (floaters) in vision
  • Increased eye pressure

These are not all of the possible side effects of BYOOVIZ. For more information, ask your doctor.
To report side effects to FDA, please call 1-800-FDA-1088.

Please see full Prescribing Information.

This information does not take the place of talking with your doctor about your medical condition or your treatment.

Prescribing Information Terms of Use Privacy Policy Contact Us Cookie Policy

© 2023 Biogen. All rights reserved. 06/23 BYO-US-0203

This site is intended for residents 18 years or older of the United States, Puerto Rico, and US territories.
Lucentis is a registered trademark of Genentech, Inc.
All other trademarks are the property of their respective owners.