Market Overview

Pfizer Receives European Approval for Oncology Biosimilar, TRAZIMERA™ (trastuzumab)

Share:

The European Commission decision marks the approval of Pfizer's first
therapeutic oncology biosimilar

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has
approved TRAZIMERA™,1 a biosimilar to Herceptin®*
(trastuzumab), for the treatment of human epidermal growth factor (HER2)
overexpressing breast cancer and HER2 overexpressing metastatic gastric
or gastroesophageal junction adenocarcinoma.2 This approval
follows the recommendation from the Committee for Medicinal Products for
Human Use in May 2018.1

"TRAZIMERA has the potential to help many patients with HER2
overexpressing cancers, such as breast and gastric, which can correlate
with poor outcomes and aggressive disease,"3,4 said Professor
Diana Lüftner, Charité Campus Benjamin Franklin and Member of the
Presidency of the German Society of Hematology and Medical Oncology.
"Today's approval will help enable greater access for patients and
physicians across Europe, without compromising on quality, efficacy and
safety."

Richard Blackburn, Global President, Pfizer Essential Health Europe,
Africa/Middle East and Biosimilars said "The approval of TRAZIMERA,
Pfizer's first oncology biosimilar, is another significant step in our
quest to introduce more treatment options for patients in Europe. Pfizer
is investing in developing and launching a range of biosimilars which
can help to reduce healthcare costs and increase patient access to
important medicines."

The EC approval is based on a comprehensive submission package which
demonstrated a high degree of similarity for TRAZIMERA and the
originator product. The data included results from the REFLECTIONS
B327-02 clinical comparative study, which showed clinical equivalence
and found no clinically meaningful differences between TRAZIMERA and
originator product in patients with first line HER2 overexpressing
metastatic breast cancer.5,6,7

TRAZIMERA is Pfizer's fourth8,9,10 biosimilar, and the first
oncology biosimilar, to receive European approval. Pfizer's biosimilars
pipeline consists of 9 distinct Pfizer and legacy Hospira biosimilar
molecules in various stages of development.

* Herceptin® is a registered trademark of Genentech – A
Member Of The Roche Group

About TRAZIMERA (trastuzumab biosimilar)

TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator
biologic medicine, Herceptin, which targets HER2, a protein found on the
surface of some cancer cells which can stimulate the cells to divide and
grow.11 It locks on to the HER2 protein and blocks the
receptor, stopping cell division and growth.11

TRAZIMERA has been studied in nearly 500 patients and across more than
20 countries to date as part of the REFLECTIONS studies.5,6,7,12,13

TRAZIMERA safety information

Do not use TRAZIMERA if you are allergic to trastuzumab or any of its
ingredients, if you have severe breathing problems at rest due to your
cancer or if you need oxygen treatment.

Before starting treatment with TRAZIMERA, tell your healthcare provider
if:

  • you have had heart failure, coronary artery disease, heart valve
    disease (heart murmurs), high blood pressure, taken any high blood
    pressure medicine or are currently taking any high blood pressure
    medicine.
  • you have ever had or are currently using a medicine called doxorubicin
    or epirubicin (medicines used to treat cancer).
  • you suffer from breathlessness, especially if you are currently using
    a taxane.
  • you have ever had any other treatment for cancer.

Like all medicines, TRAZIMERA can cause side effects, although not
everybody gets them. The most common side-effects during a TRAZIMERA
infusion are chills, fever and other flu like symptoms. Other
infusion-related symptoms include nausea, vomiting, pain, increased
muscle tension and shaking, headache, dizziness, breathing difficulties,
wheezing, high or low blood pressure, heart rhythm disturbances
(palpitations, heart fluttering or irregular heart beat), swelling of
the face and lips, rash and feeling tired. These effects mainly occur
with the first intravenous infusion ("drip" into your vein) and during
the first few hours after the start of the infusion, and are usually
temporary. Occasionally, symptoms start later than six hours after the
infusion begins. If this happens to you, contact your healthcare
provider immediately.

Other side effects can occur at any time during treatment with
TRAZIMERA, not just related to an infusion. Heart problems can sometimes
occur during treatment and occasionally after treatment has stopped and
can be serious. They include weakening of the heart muscle possibly
leading to heart failure, inflammation (swollen, red, hot, and in pain)
of the lining around the heart and heart rhythm disturbances. This can
lead to symptoms such as:

  • breathlessness (including breathlessness at night),
  • cough,
  • fluid retention (swelling) in the legs or arms,
  • palpitations (heart fluttering or irregular heart beat).

Your doctor will monitor your heart regularly during and after treatment
but you should tell your doctor immediately if you notice any of the
above symptoms.

If you experience any of the above symptoms when your treatment with
TRAZIMERA has finished, you should see your doctor and tell them that
you have previously been treated with trastuzumab.

Tell your healthcare provider if you are taking, have recently taken or
may take any other medicines.

Tell your healthcare provider if you are pregnant, plan to become
pregnant, or are breastfeeding.

Ask your healthcare provider about the risks and benefits of TRAZIMERA.
Only a healthcare provider can decide if TRAZIMERA is right for you.

You are encouraged to report negative side effects to the European
Medicines Agency. Visit http://www.adrreports.eu/.

Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com.
In addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer_NewsLinkedInYouTube and
like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of
July 31, 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 trastuzumab biosimilar and an approval by the European
Commission, including their 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, uncertainties regarding the
commercial success of TRAZIMERA; 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 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
its subsequent 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 Pfizer. Pfizer Receives Positive CHMP Opinion For Oncology
Biosimilar, Trazimera™ (Trastuzumab). June 2018. Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_positive_chmp_opinion_for_oncology_biosimilar_trazimera_trastuzumab
Accessed June 2018

2 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 June 2018

3 Macmillan. HER2 positive breast cancer. Available at https://www.macmillan.org.uk/cancerinformation/cancertypes/breast/aboutbreastcancer/typesandrelatedconditions/her2%20positive.aspx
Accessed June 2018

4 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.
Accessed June 2018

5 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.

6 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

7 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.

8 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 June 2018.

9 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 June 2018.

10 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
Accessed June 2018

11 Macmillan Cancer Support. Trastuzumab. (Herceptin)
Available at https://www.macmillan.org.uk/cancerinformation/cancertreatment/treatmenttypes/biologicaltherapies/monoclonalantibodies/trastuzumab.aspx
Accessed June 2018

12 Clinicaltrials.gov. NCT01989676. A study of PF-05280014
[trastuzumab-Pfizer] or Herceptin (trastuzumab) plus paclitaxel in HER2
positive first line metastatic breast cancer treatment (REFLECTIONS
B327-02). Available at https://clinicaltrials.gov/ct2/show/NCT01989676?term=NCT01989676&rank=1.
Accessed June 2018

13 Clinicaltrials.gov. NCT02187744. A study of PF-05280014 or
trastuzumab plus taxotere and carboplatin in HER2 positive breast cancer
in the neoadjuvant setting (REFLECTIONS B327-04). Available at https://clinicaltrials.gov/ct2/show/NCT02187744?term=NCT02187744&rank=1.
Accessed June 2018

View Comments and Join the Discussion!