May 18, 2018 PR-M05-18-NI-071
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S.
“As the first approved epoetin alfa biosimilar in the U.S., RETACRIT may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients,” said Berk Gurdogan, U.S. Institutions President, Pfizer Essential Health. “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”
The FDA approval was based on a comprehensive data package submitted by Pfizer demonstrating a high degree of similarity between RETACRIT and its U.S. reference product, Epogen and Procrit.2
In the U.S., RETACRIT is indicated for:3
“With the approval of RETACRIT, healthcare providers now have an additional option to choose from when prescribing an ESA,” said George M. Rodgers, M.D., Ph.D., Professor of Medicine, Division of Hematology and Hematologic Malignancies, Department of Internal Medicine, University of Utah School of Medicine. “By providing potentially more affordable therapeutic options, biosimilar medicines can allow for the reallocation of resources to other areas of cancer care. This is positive news for the oncology community.”
RETACRIT is expected to be available in the U.S. at a significant discount to the current wholesaler acquisition cost (WAC) of Epogen and Procrit. WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations.
Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of RETACRIT in certain channels.
RETACRIT is Pfizer’s third approved biosimilar in the U.S. Pfizer’s biosimilars pipeline consists of 11 distinct biosimilar molecules with six assets in mid-to-late stage clinical development.4
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:
For all people who take RETACRIT, including people with cancer or chronic kidney disease:
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:
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 well-being.
RETACRIT should not be used for treatment of anemia:
RETACRIT should not be used to reduce the chance of RBC transfusions if:
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:
Before taking RETACRIT, tell your healthcare provider about all of your medical conditions, including if you:
How should I take RETACRIT?
What are the possible side effects of RETACRIT?
RETACRIT may cause serious side effects, including:
Common side effects of RETACRIT include:
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?
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:
Please see full Prescribing Information for RETACRIT (epoetin alfa-epbx), including BOXED WARNING and Medication Guide.
DISCLOSURE NOTICE: The information contained in this release is as of May 15, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about RETACRIT (epoetin alfa-epbx), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the launch timing and commercial success of RETACRIT in the United States; the uncertainties inherent in research and development; whether and when any applications for RETACRIT or label updates for RETACRIT may be filed with regulatory authorities in any other jurisdictions and whether and when regulatory authorities in other jurisdictions may approve any such other applications that are pending or that may be filed for RETACRIT, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; intellectual property and/or litigation implications; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of RETACRIT; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
1 Epogen® is a registered U.S. trademark of Amgen Inc.; Procrit® is a registered U.S. trademark of Johnson & Johnson
2 U.S. Food & Drug Administration, Oncologic Drugs Advisory Committee Meeting. (2017, May 23). ODAC Briefing Document: BLA 125545 for “Epoetin Hospira”, a proposed biosimilar to Epogen/Procrit. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM559967.pdf
3 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf
4 Pfizer. (2018, January 30). Pfizer pipeline. Retrieved from https://www.pfizer.com/sites/default/files/product-pipeline/01302018_PipelineUpdate.pdf
Pfizer Inc.
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