FDA Approves Nivestym
FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.
“The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy,” said Berk Gurdogan, U.S. Institutions President, Pfizer Essential Health. “We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”
The FDA approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of Nivestym compared to its reference product.
In the U.S., Nivestym is indicated:2
- To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
- For reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
- To reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
- For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
- For chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
Nivestym is expected to be available in the U.S. at a significant discount to the current wholesale acquisition cost (WAC) of Neupogen. WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations.
Nivestym is Pfizer’s fourth biosimilar to be approved by the U.S. FDA. Pfizer’s biosimilars pipeline consists of 10 distinct biosimilar molecules with five assets in mid-to-late stage clinical development.3
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DISCLOSURE NOTICE: The information contained in this release is as of July 20, 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 Nivestym™ (filgrastim-aafi), 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 Nivestym in the United States; the uncertainties inherent in research and development; whether and when any applications for Nivestym may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities in any other jurisdictions may approve any such other applications that are pending or that may be filed for Nivestym, 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 and, if approved, whether Nivestym will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Nivestym; uncertainties regarding access challenges for our biosimilar products where our product may not receive access at parity to the innovator product and remains in a disadvantaged position; 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.
2 Nivestym™ (filgrastim-aafi) Prescribing Information. New York. NY: Pfizer Inc: 2018. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf
3 Pfizer. (2018, January 30). Pfizer pipeline. Retrieved from https://www.pfizer.com/sites/default/files/product-pipeline/01302018_PipelineUpdate.pdf
Source: Pfizer Inc.
Posted: July 2018
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