Learn About Biosimilars | RUXIENCE® (rituximab-pvvr)

What are biosimilars?

Biosimilars are highly similar to the original biologics. Although it is impossible to produce an identical copy of any biologic medicine, a biosimilar must be proven to show no clinically meaningful differences from a reference product.

Do biosimilars have the same side effects and safety profile as the reference products?

Biosimilars must demonstrate that they have no clinically meaningful differences from their reference products in terms of safety and effectiveness. They are expected to work the same way as the original medicines.

How long have biosimilars been available?

The first biosimilar was approved in the United States in 2015.

Pfizer is committed to helping patients worldwide by developing and delivering high-quality biosimilar medications to patients who need them.

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IMPORTANT SAFETY INFORMATION AND INDICATIONS

RUXIENCE can cause serious side effects that can lead to death, including:

Infusion-Related Reactions: Infusion-related reactions are very common side effects of RUXIENCE treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of RUXIENCE. Your healthcare provider should give you medicines before your infusion of RUXIENCE to decrease your chance of having a severe infusion-related reaction
Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RUXIENCE:
- Hives (red itchy welts) or rash
- Itching
- Swelling of your lips, tongue, throat, or face
- Sudden cough
- Shortness of breath, difficulty breathing, or wheezing
- Weakness
- Dizziness or feel faint
- Palpitations (feel like your heart is racing or fluttering)
- Chest pain
Severe Skin and Mouth Reactions: Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RUXIENCE:
- Painful sores or ulcers on your skin, lips, or in your mouth
- Blisters
- Peeling skin
- Rash
- Pustules
Hepatitis B Virus (HBV) Reactivation: Before you receive your RUXIENCE treatment, your healthcare provider will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of the hepatitis B virus, receiving RUXIENCE could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure, and death. You should not receive RUXIENCE if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RUXIENCE
Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RUXIENCE.
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive RUXIENCE. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML
Tell your healthcare provider right away if you have new or worsening symptoms or if anyone close to you notices these symptoms:
- Confusion
- Dizziness or loss of balance
- Difficulty walking or talking
- Decreased strength or weakness on one side of your body
- Vision problems, such as blurred vision or loss of vision

Before receiving RUXIENCE, tell your healthcare provider if you:

Have had a severe reaction to RUXIENCE or a rituximab product
Have a history of heart problems, irregular heartbeat, or chest pain
Have lung or kidney problems
Have had an infection, currently have an infection, or have a weakened immune system
Have or have had any severe infections including:
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Cytomegalovirus (CMV)
- Herpes simplex virus (HSV)
- Parvovirus B19
- Varicella zoster virus (chickenpox or shingles)
- West Nile virus
Have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RUXIENCE
Have any other medical conditions
Are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RUXIENCE during pregnancy. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test to see if you are pregnant before starting RUXIENCE and you should use effective birth control (contraception) during treatment with RUXIENCE and for 12 months after your last dose of RUXIENCE. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with RUXIENCE
Are breastfeeding or plan to breastfeed. RUXIENCE may pass into your breast milk. Do not breastfeed during treatment and for 6 months after your last dose of RUXIENCE
Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take or have taken:
- A tumor necrosis factor (TNF) inhibitor medicine
- A disease modifying anti-rheumatic drug (DMARD)

If you are not sure if your medicine is one listed above, ask your healthcare provider.

RUXIENCE can cause serious side effects, including:

Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
- Kidney failure and the need for dialysis treatment
- Abnormal heart rhythm
TLS can happen within 12 to 24 hours after an infusion of RUXIENCE. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:
- Nausea
- Vomiting
- Diarrhea
- Lack of energy

Serious Infections: Serious infections can happen during and after treatment with RUXIENCE, and can lead to death. RUXIENCE can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RUXIENCE include bacterial, fungal, and viral infections. After receiving RUXIENCE, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. People with serious infections should not receive RUXIENCE. Tell your healthcare provider right away if you have any symptoms of infection:
- Fever
- Cold symptoms, such as runny nose or sore throat, that do not go away
- Flu symptoms, such as cough, tiredness, and body aches
- Earache or headache
- Pain during urination
- Cold sores in the mouth or throat
- Cuts, scrapes, or incisions that are red, warm, swollen, or painful
Heart Problems: RUXIENCE may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RUXIENCE if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with RUXIENCE
Kidney Problems: RUXIENCE can cause severe kidney problems that lead to death, especially if you are receiving RUXIENCE for Non-Hodgkin’s Lymphoma (NHL). Your healthcare provider should do blood tests to check how well your kidneys are working
Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Bowel problems, including blockage or tears in the bowel, can happen if you receive RUXIENCE with chemotherapy medicines. Tell your healthcare provider right away if you have any stomach-area (abdomen) pain or repeated vomiting during treatment with RUXIENCE

Your healthcare provider will stop treatment with RUXIENCE if you have severe, serious, or life-threatening side effects.

Common side effects of RUXIENCE include:

Infusion-related reactions
Infections (may include fever, chills)
Body aches
Tiredness
Nausea

In adults with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) or Microscopic Polyangiitis (MPA), the most common side effects of RUXIENCE also include:

Low white and red blood cells
Swelling
Diarrhea
Muscle spasms

Other side effects with RUXIENCE include:

Aching joints during or within hours of receiving an infusion
More frequent upper respiratory tract infections

These are not all of the possible side effects with RUXIENCE.

INDICATIONS

RUXIENCE^® (rituximab-pvvr) is a prescription medicine used to treat adults with:

Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines
Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide
Rheumatoid Arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids

RUXIENCE is not indicated for treatment of children.

This information does not take the place of talking with your doctor. Discuss with your doctor any questions you have about your medical condition or your treatment.

Call your doctor for medical advice about side effects. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.

RUXIENCE is a registered trademark of Pfizer Inc.
Rituxan is a registered trademark of Biogen, Inc.