TRAZIMERA, a potential biosimilar to Herceptin® (trastuzumab),
is Pfizer’s first therapeutic oncology biosimilar to undergo regulatory
review in Europe
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE:PFE) today announced the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion, recommending marketing authorization for
TRAZIMERA™, a potential biosimilar to Herceptin®
(trastuzumab), for the treatment of HER2 overexpressing breast cancer
and HER2 overexpressing metastatic gastric or gastroesophageal junction
adenocarcinoma.1
”Pfizer is extremely proud to offer expanded biologic treatment options
for patients by bringing more affordable, life changing biosimilar
medicines to market, and today’s positive recommendation from the CHMP
marks one more step forward. TRAZIMERA has the potential to help many
patients with HER2 overexpressing cancers across Europe and, if
approved, would help address the evolving needs of healthcare systems,
physicians, payers and patients, “said Amrit Ray, MD, MBA, Global
President, Research & Development, Pfizer Essential Health.
The regulatory submission is supported with a comprehensive data package
and totality of evidence demonstrating a high degree of similarity to
the originator product. This includes results from the primary
REFLECTIONS B327-02 clinical comparative study, which demonstrated
clinical equivalence and found no clinically meaningful differences
between TRAZIMERA and Herceptin in patients with first line HER2
overexpressing metastatic breast cancer. As part of the REFLECTIONS
clinical trial program for the proposed biosimilar trastuzumab,
TRAZIMERA has been studied in nearly 500 patients and across more than
20 countries to date.2,3,4
“Many patients with breast and gastric cancers have an HER2
overexpression, which can correlate with poor outcomes and aggressive
disease,” said Dr. Mark Pegram, associate director for clinical research
at the Stanford Comprehensive Cancer Institute, and director of the
Breast Oncology Program at the Stanford Women’s Cancer Center.5,6 “With
the availability of biosimilars like TRAZIMERA in Europe, oncologists
will have additional treatment options to choose from, which potentially
helps our patients have greater access to these medicines.”
TRAZIMERA is Pfizer’s fourth7,8,9 biosimilar and first
therapeutic oncology biosimilar to receive a positive CHMP opinion from
the EMA. Pfizer’s biosimilars pipeline is progressing and consists of 11
distinct Pfizer and legacy Hospira biosimilar molecules in various
stages of development.
Working together for a healthier world
®
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DISCLOSURE NOTICE: The information contained in this release is as of
June 1, 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 TRAZIMERA,
Pfizer’s proposed trastuzumab biosimilar, including its potential
benefits, that involve 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, the uncertainties inherent in research and development,
including the ability to meet anticipated clinical trial commencement
and completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including unfavorable
new clinical data and additional analyses of existing clinical data; the
risk that clinical trial data are subject to differing interpretations,
and, even when we view data as sufficient to support the safety and/or
effectiveness of a product candidate, regulatory authorities may not
share our views and may require additional data or may deny approval
altogether; whether regulatory authorities will be satisfied with the
design of and results from our clinical studies; whether and when
applications for TRAZIMERA may be filed in any other jurisdictions;
whether and when the European Commission may approve the pending
application for TRAZIMERA in the EU and whether and when any such other
applications for TRAZIMERA that may be pending (including the
application pending with the FDA, for which the company received a
complete response letter)or filed may be approved by regulatory
authorities, 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
TRAZIMERA 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 TRAZIMERA; 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 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
itssubsequent reports on 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 European Medicines Agency. Herceptin Summary of Product
Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf.
Accessed November 2017.
2 Pegram M, Tan-Chiu E,
Freyman A, et al. Abstract 238PD. A randomized, double-blind study of
PF-05280014 (a potential trastuzumab biosimilar) vs trastuzumab, both in
combination with paclitaxel, as first-line treatment for HER2-positive
metastatic breast cancer. Presented at ESMO 2017.
3
Lammers PE, Dank M, Masetti R, et al. A randomized, double-blind study
of PF-05280014 (a potential biosimilar) vs trastuzumab, both given with
docetaxel (D) and carboplatin (C), as neoadjuvant treatment for operable
human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Abstract 154PD. Presented at ESMO 2017
4 Yin D, Barker K
B, Li R, et al. A randomized phase 1 pharmacokinetic trial comparing the
potential biosimilar PF-05280014 with trastuzumab in healthy volunteers
(REFLECTIONS B327-01). BR J Clin Pharmacol. 2014. 78(6): 1281-90.
5
Macmillan. HER2 positive breast cancer. Available at https://www.macmillan.org.uk/cancerinformation/cancertypes/breast/aboutbreastcancer/typesandrelatedconditions/her2%20positive.aspx
6
Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in
Cancers: Overexpression and Therapeutic Implications. Mol Biol Int.
2014. 10.1155/2014/852748. Pfizer. (2018, January 30). Pfizer pipeline.
Retrieved from https://www.pfizer.com/sites/default/files/product-pipeline/01302018_PipelineUpdate.pdf.
7
European Medicines Agency. European public assessment report (EPAR) for
RETACRIT. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000872/human_med_001031.jsp&mid=WC0b01ac058001d124
Accessed May 2018.
8 European Medicines Agency. European
public assessment report (EPAR) for INFLECTRA. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002778/human_med_001677.jsp&mid=WC0b01ac058001d124
Accessed May 2018.
9 European Medicines Agency. European
public assessment report (EPAR) for NIVESTIM. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001142/human_med_001344.jsp&mid=WC0b01ac058001d124
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Source: Pfizer Inc.