Learn About Biosimilars | TRAZIMERA™ (trastuzumab-qyyp)

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 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.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Possible Serious Side Effects With TRAZIMERA

Not all people have serious side effects, but side effects with trastuzumab-product therapy are common.

Although some people may have a life-threatening side effect, most do not.

Your doctor will stop treatment if any serious side effects occur.

TRAZIMERA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both trastuzumab and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with TRAZIMERA.

Contact your doctor immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness, or loss of consciousness.

INFUSION REACTIONS, including:

Fever and chills
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Pain (in some cases at tumor sites)
Headache
Dizziness
Shortness of breath

These signs usually happen within 24 hours after receiving trastuzumab products.

Be sure to contact your doctor if you:

Are a woman who could become pregnant, or may be pregnant

Use of trastuzumab products may result in the death of an unborn baby or birth defects. Contraception should be used while receiving TRAZIMERA and for 7 months after your last dose of TRAZIMERA.

Have any signs of SEVERE LUNG PROBLEMS, including:

Severe shortness of breath
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
Swelling of the lungs
Scarring of the lungs

Your doctor may check for signs of severe lung problems when he or she examines you.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving trastuzumab plus chemotherapy than in patients receiving chemotherapy alone.

Your doctor may check for signs of low white blood cell counts when he or she examines you.

Side Effects Seen Most Often With Trastuzumab Products

Some patients receiving trastuzumab for breast cancer had the following side effects:

Fever
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Infusion reactions
Diarrhea
Infections
Increased cough
Headache
Feeling tired
Shortness of breath
Rash
Low white and red blood cell counts
Muscle pain

Some patients receiving trastuzumab for metastatic stomach cancer had the following side effects:

Low white blood cell counts
Diarrhea
Feeling tired
Low red blood cell counts
Swelling of the mouth lining
Weight loss
Upper respiratory tract infections
Fever
Low platelet counts
Swelling of the mucous membranes
Swelling of the nose and throat
Change in taste

You should contact your doctor immediately if you have any of the side effects listed above.

INDICATIONS

Adjuvant Breast Cancer

TRAZIMERA is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive ( HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* TRAZIMERA can be used in several different ways:

As part of a treatment course that includes the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
With the chemotherapy drugs docetaxel and carboplatin
Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin) based therapy (a type of chemotherapy)

Patients are selected for therapy based on an FDA-approved test for trastuzumab products.

*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer

TRAZIMERA has 2 approved uses in metastatic breast cancer:

TRAZIMERA, in combination with the chemotherapy drug paclitaxel, is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive ( HER2+) metastatic breast cancer
TRAZIMERA alone is approved for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

Patients are selected for therapy based on an FDA-approved test for trastuzumab products.

Gastric Cancer

TRAZIMERA is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.

Patients are selected for therapy based on an FDA-approved test for trastuzumab products.

Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

TRAZIMERA is a registered trademark of Pfizer Inc.
Herceptin is a registered trademark of Genentech, Inc.

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