Pfizer Introduced Biosimilar RETACRIT (epoetin alfa-epbx) Injection In The U.S. At A Substantial Discount

RETACRIT to be Priced 57.1% Below the Wholesale Acquisition Cost (WAC) of Procrit (epoetin alfa) and 33.5% Below the WAC of Epogen (epoetin alfa)

Pfizer Inc. recently announced the introduction of RETACRIT (epoetin alfa-epbx) injection, the first available biosimilar to Procrit (epoetin alfa) and Epogen (epoetin alfa) in the United States, at a substantial discount. Pfizer began shipment of RETACRIT to wholesalers in the U.S. on November 12, 2018.

RETACRIT will be introduced at a Wholesale Acquisition Cost (WAC) of $11.03 per 1,000 units/mL, which is 57.1% below the WAC of Procrit (epoetin alfa) [$25.72 per 1,000 units/mL] and 33.5% below the WAC of Epogen (epoetin alfa) [$16.58 per 1,000 units/mL], its reference product.1 WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations.

The Centers for Medicare and Medicaid Services (CMS) has granted two unique assigned Q codes for RETACRIT: Q5105 for End-Stage Renal Disease (ESRD) on dialysis and Q5106 for non-ESRD. Additionally, 2 RETACRIT qualifies for pass-through status under the hospital outpatient prospective payment system (OPPS).

“We are delighted to introduce our third biosimilar in the United States,” said John P. Kennedy, General Manager, U.S. Biosimilars, Pfizer Essential Health. “Pfizer is committed to fostering a sustainable marketplace for biosimilars and advocates for policies that bring these important medicines to patients and physicians as quickly as possible.”

RETACRIT is Pfizer’s third available biosimilar in the U.S. Pfizer also has an extensive biosimilars pipeline, including three biosimilars products currently accepted for review by the FDA. Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of RETACRIT in certain channels.

RETACRIT Important Safety Information

What is the most important information I should know about RETACRIT?
RETACRIT may cause serious side effects that can lead to death, including:

For people with cancer:

• Your tumor may grow faster and you may die sooner if you choose to take RETACRIT. Your healthcare provider will talk with you about these risks.

For all people who take RETACRIT, including people with cancer or chronic kidney disease:

• Serious heart problems, such as heart attack or heart failure and stroke. You may die sooner if you are treated with RETACRIT to increase red blood cells (RBCs) to near the same level found in healthy people.
• Blood clots. Blood clots may happen at any time while taking RETACRIT. If you are receiving RETACRIT for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a 3 blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).
• Call your healthcare provider or get medical help right away if you have any of these symptoms:
  • Chest pain
  • Trouble breathing or shortness of breath
  • Pain in your legs, with or without swelling
  • A cool or pale arm or leg
  • Sudden confusion, trouble speaking, or trouble understanding others’ speech
  • Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
  • Sudden trouble seeing
  • Sudden trouble walking, dizziness, loss of balance or coordination o Loss of consciousness (fainting)
  • Hemodialysis vascular access stops working

See “What are the possible side effects of RETACRIT?” below for more information.

If you decide to take RETACRIT, your healthcare provider should prescribe the smallest dose of RETACRIT that is necessary to reduce your chance of needing RBC transfusions.

What is RETACRIT?
RETACRIT is a prescription medicine used to treat anemia. People with anemia have a lower-than normal number of RBCs. RETACRIT works like the human protein called erythropoietin to help your body make more RBCs. RETACRIT is used to reduce or avoid the need for RBC transfusions.

RETACRIT may be used to treat anemia if it is caused by:

• Chronic kidney disease (you may or may not be on dialysis).
• Chemotherapy that will be used for at least two months after starting RETACRIT.
• A medicine called zidovudine (AZT) used to treat HIV infection.

RETACRIT may also be used to reduce the chance you will need RBC transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected.

If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take RETACRIT, even if you do not have an increase in your hemoglobin level.

RETACRIT has not been proven to improve quality of life, fatigue, or wellbeing.

RETACRIT should not be used for treatment of anemia:

• If you have cancer and you will not be receiving chemotherapy that may cause anemia.
• If you have a cancer that has a high chance of being cured. Talk with your healthcare provider about the kind of cancer you have.
• If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
• In place of emergency treatment for anemia (RBC transfusions).

RETACRIT should not be used to reduce the chance of RBC transfusions if:

• You are scheduled for surgery on your heart or blood vessels.
• You are able and willing to donate blood prior to surgery.

It is not known if RETACRIT is safe and effective in treating anemia in children less than 1 month old who have chronic kidney disease and in children less than 5 years old who have anemia caused by chemotherapy.

Who should not take RETACRIT?

Do not take RETACRIT if you:

• Have cancer and have not been counseled by your healthcare provider about treatment with RETACRIT.
• Have high blood pressure that is not controlled (uncontrolled hypertension).
• Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts 5 after treatment with RETACRIT or other erythropoietin protein medicines.
• Have had a serious allergic reaction to RETACRIT or other epoetin alfa products.

Before taking RETACRIT, tell your healthcare provider about all of your medical conditions, including if you:

• Have heart disease.
• Have high blood pressure.
• Have had a seizure (convulsion) or stroke.
• Have phenylketonuria. RETACRIT contains phenylalanine (a component of aspartame).
• Receive dialysis treatment
• Are pregnant or plan to become pregnant. It is not known if RETACRIT may harm your unborn baby. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you.
• Are breastfeeding or plan to breastfeed. It is not known if RETACRIT passes into breast milk.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take RETACRIT?

• If you or your caregiver has been trained to give RETACRIT shots (injections) at home:
  • Be sure that you read, understand, and follow the “Instructions for Use” that come with RETACRIT.
  • Take RETACRIT exactly as your healthcare provider tells you to. Do not change the dose of RETACRIT unless told to do so by your healthcare provider.
  • Your healthcare provider will show you how much RETACRIT to use, how to inject it, how often it should be injected, and how to safely throw away the used vials, syringes, and needles.
  • If you miss a dose of RETACRIT, call your healthcare provider right away and ask what to do. 6
  • If you take more than the prescribed dose of RETACRIT, call your healthcare provider right away.
• During treatment with RETACRIT, continue to follow your healthcare provider’s instructions for die and medicines.
• Have your blood pressure checked as instructed by your healthcare provider.

What are the possible side effects of RETACRIT?
RETACRIT may cause serious side effects, including:​

• See “What is the most important information I should know about RETACRIT?”
• High blood pressure. High blood pressure is a common side effect of RETACRIT in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking RETACRIT. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine.
• Seizures. If you have any seizures while taking RETACRIT, get medical help right away and tell your healthcare provider.
• Antibodies to RETACRIT. Your body may make antibodies to RETACRIT. These antibodies can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking RETACRIT.
• Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using RETACRIT and call your healthcare provider or get medical help right away.
• Severe skin reactions. Signs and symptoms of severe skin reactions with RETACRIT may include: skin rash with itching, blisters, skin sores, peeling, or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using RETACRIT and call your healthcare provider or get medical help right away.

Common side effects of RETACRIT include:

• joint, muscle, or bone pain
• fever
• cough
• dizziness
• high blood sugar
• low potassium levels in the blood
• chills
• rash
• nausea
• vomiting
• blood vessel blockage
• low white blood cells
• trouble sleeping
• difficulty swallowing
• soreness of mouth
• itching
• headache
• respiratory infection
• weight decrease
• depression
• muscle spasm
• redness and pain at the RETACRIT injection site

These are not all of the possible side effects of RETACRIT. Your healthcare provider can give you a more complete list. Tell your healthcare provider about any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store RETACRIT?

• Do not shake RETACRIT.
• Store RETACRIT vials in the carton it comes in to protect from light.
• Store RETACRIT in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze RETACRIT. Do not use RETACRIT that has been frozen. 8
• Single-dose vials of RETACRIT should be used only one time. Throw the vial away after use even if there is medicine left in the vial.

Keep RETACRIT and all medicines out of the reach of children.
General information about RETACRIT.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RETACRIT for a condition for which it was not prescribed. Do not give RETACRIT to other people even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about RETACRIT that is written for healthcare professionals.

What are the ingredients in RETACRIT?
Active Ingredient: epoetin alfa-epbx
Inactive Ingredients:

• All vials contain calcium chloride dehydrate, glycine, isoleucine, leucine, L-glutamic acid, phenylalanine, polysorbate 20, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and threonine, in water for injection.

Please see full Prescribing Information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf) for RETACRIT (epoetin alfaepbx), including BOXED WARNING and Medication Guide.

Working together for a healthier world
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked 9 to make a difference for all who rely on us. For more information, visit www.pfizer.com.