On April 2, 2020 Pfizer Inc. (NYSE: PFE) reported that the European Commission (EC) has approved RUXIENCE (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera (rituximab), for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).1,2,3 (Press release, Pfizer, APR 2, 2020, View Source [SID1234556103])
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"The approval of biosimilars such as RUXIENCE is an important development for the treatment of certain cancers and autoimmune conditions," said Igor Aurer, M.D., Ph.D., Professor of Medicine and Head of Hematology Division, University Hospital Centre Zagreb, Croatia. "It’s a step toward allowing clinicians an additional treatment option which can help improve access for patients in need of this established medicine."
The EC approval is based on a comprehensive data package which demonstrated biosimilarity of RUXIENCE to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of RUXIENCE and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.4
"Biosimilars like RUXIENCE exhibit a similar safety and efficacy profile to the originator product and have the potential to improve treatment access while reducing healthcare costs," said Masum Hossain, regional president, Oncology International Developed Markets at Pfizer. "Building on our ongoing commitment to bring biosimilars to market, we look forward to making RUXIENCE available to patients in the EU in the coming months."
Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to help create more sustainable healthcare systems. With more than 10 years of global in-market experience and a portfolio which now includes seven approved biosimilar products in Europe, Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. This approval follows the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in January 2020.5 RUXIENCE was recently made available to adult patients in the United States for the treatment of NHL, CLL, GPA and MPA and also launched in Japan in January 2020.
About RUXIENCE (rituximab biosimilar)
RUXIENCE is a monoclonal antibody (mAb) biosimilar to MabThera which works by targeting a protein called CD20, which is present on the surface of B lymphocytes, also known as B cells. When it attaches to CD20, rituximab helps destroy these B cells.
RUXIENCE safety information
Do not use RUXIENCE if you are allergic to rituximab or other proteins which are like rituximab or any of the other ingredients of this medicine, if you have a severe active infection at the moment or if you have a weak immune system.
RUXIENCE should also not be used if you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.
Before starting treatment with RUXIENCE, talk to your doctor, pharmacist or nurse if:
you have ever had or might now have a hepatitis infection. This is because in a few cases, RUXIENCE could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection
you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems
you are pregnant, think that you might be pregnant or are planning to become pregnant
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. In particular, tell your doctor if:
you are taking medicines for high blood pressure
you have ever taken medicines which affect your immune system – such as chemotherapy or immune-suppressive medicines
If you have been diagnosed with rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, also tell your doctor if:
you think you may have an infection, even a mild one like a cold. The cells that are affected by RUXIENCE help to fight infection and you should wait until the infection has passed before you are given RUXIENCE
you had a lot of infections in the past or suffer from severe infections
you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as RUXIENCE or in the months after you receive RUXIENCE
If you are not sure, talk to your healthcare professional before you are given RUXIENCE.
Like all medicines, RUXIENCE can cause side effects, although not everybody gets them. Most side effects are mild to moderate, but some may be serious and require treatment. Rarely, some of these reactions have been fatal.
Infusion reactions
RUXIENCE is given by intravenous infusion into your vein. During or within the first 24-hours of the infusion you may develop fever, chills and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these reactions might get worse.
Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped. You may require additional treatment such as an antihistamine or paracetamol.
Infections
You might get infections more easily during your treatment with RUXIENCE. Tell your doctor immediately if you get signs of an infection including:
fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell
memory loss, trouble thinking, difficulty walking or sight loss – these may be due to a very rare, serious brain infection, which has been fatal (Progressive Multifocal Leukoencephalopathy or PML)
If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver. Your doctor will also give you a patient booklet with more detailed information on the risks and symptoms of infections and PML.
Skin reactions
Very rarely, severe blistering skin conditions that can be life-threatening may occur. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Tell your doctor immediately if you experience any of these symptoms.
Other very common side effects of RUXIENCE treatment include:
If you are being treated for non-Hodgkin’s lymphoma or chronic lymphocytic leukemia:
bacterial or viral infections, bronchitis
low number of white blood cells, with or without fever or blood cells called "platelets"
feeling sick (nausea)
bald spots on the scalp, chills, headache
lower immunity – because of lower levels of antibodies called "immunoglobulins" (IgG) in the blood which help protect against infection
If you are being treated for rheumatoid arthritis:
infections such as pneumonia (bacterial)
pain on passing water (urinary tract infection)
allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion
changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness
headache
changes in laboratory tests carried out by your doctor. These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection
If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis:
infections, such as chest infections, pain on passing water (urinary tract infections), colds and herpes infections
allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion
diarrhea
coughing or shortness of breath
nose bleeds
raised blood pressure
painful joints or back
muscle twitches or shakiness
feeling dizzy
tremors (shakiness, often in the hands)
difficulty sleeping (insomnia)
swelling of the hands or ankles
If you are being treated for pemphigus vulgaris:
allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
long lasting depression
loss of hair
RUXIENCE may also cause changes in laboratory tests carried out by your doctor. If you are having RUXIENCE with other medicines, some of the side effects you may get may be due to the other medicines.
Please refer to the European Summary of Product Characteristics for RUXIENCE for complete safety information.