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.
Biological products are the fastest-growing class of therapeutic products in the United States.

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.

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Indication and Important
Safety Information
What is BYOOVIZ® (ranibizumab-nuna) injection? 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

IMPORTANT SAFETY INFORMATION

What Important Safety Information should I know about BYOOVIZ?

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

BYOOVIZ is a prescription medication given by injection into the eye, and it has side effects.

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. Some patients have had increases in eye pressure before and within 1 hour of an injection. 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
  • Severe inflammation of vessels in the retina, with or without blockage, have been reported with the use of ranibizumab products. Call your healthcare provider immediately if you experience any changes in vision
  • Some patients using ranibizumab products have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts
The most common eye-related side effects include:
  • Increased redness in the white of the eye
  • Eye pain
  • Small specks (floaters) in vision
  • Increased eye pressure

The most common non–eye-related side effects are nose and throat infections, anemia, nausea and cough.

You are encouraged to report suspected adverse reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.