FDA approves first biosimilar ZarxioTM (filgrastim-sndz) from Sandoz
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FDA approves first biosimilar ZarxioTM (filgrastim-sndz) from Sandoz
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* Sandoz is the first company to receive approval of a biosimilar in the US
through the new FDA biosimilars pathway established under BPCIA
* Zarxio is approved for all indications included in the reference product's
(NEUPOGEN®) label
* Approval paves way for greater access to high-quality biologics in the US
and underscores Sandoz global leadership in biosimilars
Holzkirchen, March 6, 2015 - Sandoz, a Novartis company, announced today that
the US Food and Drug Administration (FDA) approved Zarxio(TM) (filgrastim-sndz)
for all indications included in the reference product's label. Sandoz is the
first company to receive approval of a biosimilar in the US through the new FDA
biosimilars pathway established under the Biologics Price Competition and
Innovation Act. The approval was based on a comprehensive package of analytical,
nonclinical, and clinical data, which confirmed that Zarxio is highly similar to
the US-licensed reference product. The approval of Zarxio follows the unanimous
positive vote in January by the Oncologic Drugs Advisory Committee (ODAC).
"The FDA approval of Zarxio marks a significant milestone for the United States
healthcare system and for patients who might suffer from neutropenia," said
Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz.
"As the global leader in biosimilars, we are honored to be the first company to
successfully work with FDA to navigate the US biosimilar pathway and we look
forward to making this high-quality biosimilar available to patients in the US."
"Filgrastim has proven clinical value in treating patients at increased risk of
neutropenia, but it is underused in the US for a variety of reasons, including
price" said Dr. Louis Weiner, chairman of the department of oncology and
director of the Lombardi Comprehensive Cancer Center at Georgetown University.
"Biosimilars have the potential to increase access and the approval of Zarxio
may reduce costs to the healthcare system. The comprehensive data set supports
its use in clinical practice."
The successful Sandoz pivotal head-to-head PIONEER study was the final piece of
data contributing to the totality of evidence used by FDA to approve Zarxio as
biosimilar to the reference product. Importantly, the data demonstrating high
similarity was sufficient to allow extrapolation of use of Zarxio to all
indications of the reference product. In the PIONEER study, Zarxio and the
reference product both produced the expected reduction in the duration of severe
neutropenia in cancer patients undergoing myelosuppressive chemotherapy (1.17
and 1.20 days for Zarxio and the reference product, respectively). The mean time
to absolute neutrophil count recovery in cycle 1 was also similar (1.8 days ±
0.97 in ZARXIO arm vs 1.7 days ± 0.81 in reference product arm). No
immunogenicity or antibodies against rhG-CSF were detected throughout the
study.
Marketed as Zarzio(®) outside of the US, the Sandoz biosimilar filgrastim is
available in more than 60 countries worldwide, has generated over 7.5 million
patient-days of exposure and is the most widely used filgrastim in Europe.
Sandoz has a commitment to increasing patient access to high-quality
biosimilars. Sandoz is the global market leader with over 50 percent volume
share of biosimilars approved in North America, Europe, Japan and Australia.
Sandoz currently markets three biosimilars (somatropin, filgrastim and epoetin
alfa) outside the US; each of which occupies the #1 biosimilar position in its
respective category. The Sandoz pipeline has several biosimilars across the
various stages of development, including five programs in Phase III clinical
trials/filing preparation - more than any other company in the industry.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
* Zarxio is contraindicated in patients with a history of serious allergic
reactions to human granulocyte colony-stimulating factors such as filgrastim
or pegfilgrastim.
WARNINGS AND PRECAUTIONS
* Splenic rupture, including fatal cases, has been reported following the
administration of filgrastim products. Patients who report left upper
abdominal or shoulder pain should be evaluated.
* Acute respiratory distress syndrome (ARDS) has been reported in patients
receiving filgrastim products. Patients who develop fever and lung
infiltrates or respiratory distress should be evaluated. Discontinue Zarxio
in patients with ARDS.
* Serious allergic reactions, including anaphylaxis, have been reported in
patients receiving filgrastim products. The majority of reported events
occurred upon initial exposure. Provide symptomatic treatment for allergic
reactions. Allergic reactions, including anaphylaxis, in patients receiving
filgrastim products can recur within days after the discontinuation of
initial anti-allergic treatment. Permanently discontinue Zarxio in patients
with serious allergic reactions.
* Sickle cell crisis, in some cases fatal, has been reported with the use of
filgrastim products in patients with sickle cell trait or sickle cell
disease.
* Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis
requiring hospitalization have been reported in healthy donors treated with
filgrastim undergoing peripheral blood progenitor cell (PBPC) collection
mobilization. Hemoptysis resolved with discontinuation of filgrastim. The
use of Zarxio for PBPC mobilization in healthy donors is not an approved
indication.
* Capillary leak syndrome (CLS) has been reported after G-CSF administration,
including filgrastim products, and is characterized by hypotension,
hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency,
severity and may be life-threatening if treatment is delayed. Patients who
develop symptoms of capillary leak syndrome should be closely monitored and
receive appropriate treatment.
* Confirm the diagnosis of severe chronic neutropenia (SCN) before initiating
Zarxio therapy. Myelodysplastic syndrome (MDS) and acute myelogenous
leukemia (AML) have been reported to occur in the natural history of
congenital neutropenia without cytokine therapy. Cytogenetic abnormalities,
transformation to MDS, and AML have also been observed in patients treated
with filgrastim for SCN. Abnormal cytogenetics and MDS have been associated
with the eventual development of myeloid leukemia. The effect of filgrastim
products on the development of abnormal cytogenetics and the effect of
continued filgrastim administration in patients with abnormal cytogenetics
or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or
myelodysplasia, the risks and benefits of continuing Zarxio should be
carefully considered.
* Thrombocytopenia has been reported in patients receiving filgrastim
products. Monitor platelet counts.
* Leukocytosis:
* Patients with Cancer Receiving Myelosuppressive Chemotherapy: White
blood cell counts of 100,000/mm(3) or greater were observed in
approximately 2% of patients receiving filgrastim at dosages above 5
mcg/kg/day. In patients with cancer receiving ZARXIO as an adjunct to
myelosuppressive chemotherapy, to avoid the potential risks of excessive
leukocytosis, it is recommended that ZARXIO therapy be discontinued if
the ANC surpasses 10,000/mm(3) after the chemotherapy-induced ANC nadir
has occurred. Monitor CBCs at least twice weekly during therapy.
* Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy: During
the period of administration of Zarxio for PBPC mobilization in patients
with cancer, discontinue Zarxio if the leukocyte count rises to
>100,000/mm(3).
* Cutaneous vasculitis has been reported in patients treated with filgrastim
products. In most cases, the severity of cutaneous vasculitis was moderate
or severe. Most of the reports involved patients with SCN receiving long-
term filgrastim therapy. Hold Zarxio therapy in patients with cutaneous
vasculitis. Zarxio may be started at a reduced dose when the symptoms
resolve and the ANC has decreased.
* The possibility that filgrastim acts as a growth factor for any tumor type,
including myeloid malignancies and myelodysplasia, diseases for which
filgrastim is not approved, cannot be excluded. The safety of filgrastim
products in chronic myeloid leukemia (CML) and myelodysplasia has not been
established. When Zarxio is used to mobilize PBPC, tumor cells may be
released from the marrow and subsequently collected in the leukapheresis
product. Available data is limited and inconclusive.
* The safety and efficacy of filgrastim products given simultaneously with
cytotoxic chemotherapy have not been established. Do not use Zarxio in the
period 24 hours before through 24 hours after the administration of
cytotoxic chemotherapy. The safety and efficacy of filgrastim products have
not been evaluated in patients receiving concurrent radiation therapy. Avoid
the simultaneous use of Zarxio with chemotherapy and radiation therapy.
* Increased hematopoietic activity of the bone marrow in response to growth
factor therapy has been associated with transient positive bone-imaging
changes on nuclear imaging.
ADVERSE REACTIONS
Most common adverse reactions in patients:
* With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
(>= 5% difference in incidence compared to placebo) are thrombocytopenia,
nausea, pyrexia, chest pain, pain, fatigue, back pain, arthralgia, bone
pain, pain in extremity, dizziness, cough, dyspnea, rash, blood lactate
dehydrogenase increased and blood alkaline phosphatase increased
* With AML (>= 2% difference in incidence) are epistaxis, back pain, pain in
extremity, erythema, and rash maculo-papular
* With nonmyeloid malignancies undergoing myeloablative chemotherapy followed
by BMT (>= 5% difference in incidence) are rash and hypersensitivity
* Undergoing peripheral blood progenitor cell mobilization and collection
(>= 5% incidence) are bone pain, pyrexia, blood alkaline phosphatase
increased and headache
* With severe chronic neutropenia (SCN) (>= 5% difference in incidence) are
arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain
in extremity, splenomegaly, anemia, upper respiratory tract infection,
urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and
alopecia
Please click here for full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Neutropenia
Neutropenia is a condition characterized by a low amount of neutrophils in your
blood - one of the most common types of white blood cells - whose role is to
protect the body from infections. Neutropenia occurs often following cancer
treatments, as well as advanced HIV infections. Filgrastim is a naturally
occurring protein produced commercially by recombinant DNA technology, which
stimulates production of white blood cells.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "paves way," "look forward," "potential," "commitment," or
similar terms, or by express or implied discussions regarding potential future
product approvals, or regarding potential revenues from Zarxio, or potential
future products. You should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and expectations of
management regarding future events, and are subject to significant known and
unknown risks and uncertainties. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the forward-looking
statements. There can be no guarantee that biosimilar filgrastim will be
submitted for sale in any additional markets, or at any particular time. Nor
can there be any guarantee that Zarxio, or any potential future products will be
commercially successful in the future. In particular, management's expectations
regarding Zarxio, or such potential future products could be affected by, among
other things, unexpected clinical trial results and additional analysis of
existing clinical data; unexpected regulatory actions or delays or government
regulation generally; competition in general, including potential approval of
additional versions of biosimilar filgrastim; government, industry and general
public pricing pressures; unexpected intellectual property litigation outcomes;
unexpected manufacturing issues; general economic and industry conditions, and
other risks and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Novartis is providing the
information in this press release as of this date and does not undertake any
obligation to update any forward-looking statements contained in this press
release as a result of new information, future events or otherwise.
About Sandoz
Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals,
driving sustainable access to high-quality healthcare. Sandoz employs more than
26,000 people worldwide and supplies a broad range of affordable, primarily off-
patent products to patients and customers around the globe.
The Sandoz global portfolio comprises approximately 1,100 molecules, which
accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position
in biosimilars as well as in generic anti-infectives, ophthalmics and
transplantation medicines. In addition, Sandoz holds leading global positions in
key therapeutic areas ranging from generic injectables, dermatology and
respiratory to cardiovascular, metabolism, central nervous system, pain and
gastrointestinal. Sandoz develops, produces and markets finished dosage form
(FDF) medicines as well as intermediary products including active pharmaceutical
ingredients (APIs) and biotechnological substances. Nearly half of Sandoz's
portfolio is in differentiated products - products that are scientifically more
difficult to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses
under the Sandoz brand name in 2003, Sandoz has consistently driven growth in
selected geographies and differentiated product areas through a series of
targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria), and
Fougera Pharmaceuticals (US).
Sandoz is on Twitter. Sign up to follow (at)Sandoz_global at
http://twitter.com/Sandoz_Global
# # #
For further information:
Eric Althoff Sreejit Mohan
Novartis Global Media Relations Sandoz Head Biopharma & OI Communications
+41-61-324-7999 +49 (0) 162 429 7971
+41-79-593-4202 sreejit.mohan(at)sandoz.com
eric.althoff(at)novartis.com
Leslie Pott
Sandoz US Communications
+1-609-627-5287
+1-201-354-0279
leslie.pott(at)sandoz.com
Novartis Investor Relations
Central phone: +41 61 324 7944 North America:
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Susan Donofrio +1 862 778 9257
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
e-mail: investor.relations(at)novartis.com
Footnotes:
1. NEUPOGEN® is a registered trademark of Amgen.
2. ZARXIO(TM) is a trademark of Novartis AG.
3. ZARZIO® is a registered trademark of Novartis AG.
Media release (PDF):
http://hugin.info/134323/R/1900097/675245.pdf
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Source: Novartis International AG via GlobeNewswire
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Datum: 06.03.2015 - 15:10 Uhr
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