HERTFORDSHIRE, England,
PITTSBURGH and BENGALURU,
India, Dec.
2, 2019 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced the
U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar
to Herceptin® (trastuzumab). Ogivri
is available in a 420mg multi-dose vial and a 150mg single-dose
vial in order to provide patient dosing and treatment flexibility.
Ogivri was the first biosimilar trastuzumab approved by the U.S.
Food and Drug Administration (FDA) and unanimously recommended
by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is
approved for all indications of Herceptin including for the
treatment of HER2-overexpressing breast cancer and metastatic
stomach cancer (gastric or gastroesophageal junction
adenocarcinoma). Trastuzumab and biosimilar trastuzumab products
contain a Boxed Warning for cardiomyopathy, infusion reactions,
pulmonary toxicity and embryo-fetal toxicity.
Two supplemental Biologics License Applications were recently
approved by the FDA, expanding the manufacturing capability for
Ogivri, as well as Mylan and Biocon's first U.S. biosimilar,
Fulphila®, a biosimilar to Neulasta®. Mylan
and Biocon Biologics have sufficient manufacturing capacity to
fulfil demand in the U.S. and global markets for both products.
Mylan President Rajiv Malik commented: "As one of the
largest suppliers of oncology medicines in the U.S., we are proud
to offer Ogivri, biosimilar trastuzumab, in both the 420mg and
150mg strengths and help increase more affordable access to this
important treatment option for breast and gastric cancer
patients. With regulatory approval for our biosimilar
trastuzumab in more than 80 countries worldwide, we are bringing
vast global biosimilars experience to the U.S. and look forward to
continuing our work with all stakeholders in the healthcare system
to reduce costs, improve access and advance care. With Ogivri,
Fulphila and our generic oncology portfolio, Mylan is uniquely
positioned to provide a broad range of treatment options for
oncology patients.
Malik continued, "Today's launch has been achieved through years
of hard work as a result of our successful collaboration with
Biocon. Our early settlement and license with Roche to bring this
product to market allows us to launch Ogivri without legal
risk."
Dr. Christiane Hamacher, CEO,
Biocon Biologics, said: "The U.S. launch of Ogivri, the biosimilar
trastuzumab co-developed by Biocon Biologics and Mylan, marks a
significant milestone in our biosimilars journey. It is an
important endorsement of our science, development and
manufacturing capabilities in the area of monoclonal antibodies.
The introduction of both 420mg multi-use vials and 150mg single-use
vials of a high quality biosimilar trastuzumab with robust
long-term efficacy and safety data will offer greater choice and
value to patients, prescribers and payors in the U.S. As a
global frontrunner in biosimilars, Biocon Biologics is
committed to fulfil unmet patient needs by providing greater
affordability for enhanced patient access. We aspire to serve 5
million patients through our biosimilars portfolio and cross a
revenue milestone of US$ 1bn by
FY22.
"Ogivri is the second biosimilar from our partnered portfolio
being commercialized by Mylan in the U.S. Last year, through the
launch of Fulphila we helped in expanding patient access to
biosimilar pegfilgrastim," she added.
FDA approval of Ogivri was based on robust data demonstrating
that Ogivri is highly similar to Herceptin and no clinically
meaningful differences exist between the biosimilar product and
Herceptin in terms of safety, purity and potency. Long-term results
of the landmark HERITAGE study including overall survival data at
36 months were presented at this year's American Society of
Clinical Oncology (ASCO) Annual Meeting.
Dr. Hope S. Rugo, professor of
medicine at the University of California, San
Francisco, and lead author of the HERITAGE study commented:
"Trastuzumab-dkst (Ogivri) has many firsts to its credit. It was
one of the first biosimilar oncology products to get a unanimous
approval vote at an ODAC meeting, and it was the first biosimilar
study to be published in the Journal of the American Medical
Association. In this context, the HERITAGE study had a unique trial
design that not only evaluated objective response rate at week 24
as its primary endpoint but also assessed key endpoints including
progression-free survival rate and overall survival at 36 months.
The concordant efficacy data across all three endpoints
conclusively demonstrated that Ogivri was similar to Herceptin, and
patients without progression now continue on Ogivri as maintenance
therapy. We are pleased that patients with HER2-positive cancers
now have an additional treatment option backed by robust safety and
efficacy data, including long-term 36-month data. The worldwide
introduction of this agent has already improved access to
trastuzumab."
Ogivri is the second biosimilar to be offered by Mylan through
the Mylan-Biocon Biologics partnership in the U.S. and the second
FDA-approved biosimilar through this collaboration to support
cancer patients. Mylan and Biocon launched the world's first
biosimilar trastuzumab in India in
2014. Today, Mylan has one of the largest and most diverse
biosimilars portfolios, with 20 biosimilar and insulin analog
products in development or on the market.
A full suite of patient services for Ogivri will be offered
through the Mylan Advocate program.
About the HERITAGE Study
HERITAGE is a double-blind, randomized clinical trial designed
to evaluate comparative efficacy and safety of the trastuzumab
biosimilar trastuzumab-dkst (formerly known as MYL-1401O) versus
branded trastuzumab. Eligible patients had centrally confirmed,
measurable HER2-positive metastatic breast cancer without prior
chemotherapy or trastuzumab for metastatic disease. Patients were
randomized to receive either trastuzumab-dkst or branded
trastuzumab with docetaxel or paclitaxel for a minimum of eight
cycles. Trastuzumab was continued until progression. The primary
endpoint is overall response at week 24 by blinded central
evaluation using RECIST 1.1. Secondary endpoints include
progression free survival, overall survival, and safety. A sample
size of 456 patients was calculated to demonstrate equivalence in
overall response at week 24 for trastuzumab-dkst versus branded
trastuzumab, defined as a 90% confidence interval for the ratio of
best overall response within the equivalence margin (0.81,
1.24).The primary endpoint has previously been reported: the
overall response rate in patients with HER2-positive metastatic
breast cancer at week 24 was equivalent between the
trastuzumab-dkst and trastuzumab groups (Rugo et al. JAMA.
2017;317:37-47).
Bringing Access to Biologics
Biologic drugs, like Herceptin, represent a large and increasing
portion of the overall prescription drug market. They are important
in the treatment of many chronic and acute diseases, including
cancer. However, these drugs can cost far more than traditional
prescription drugs, and their cost can prohibit access. One study
found that nearly 40% of women were at least somewhat worried about
finances because of their breast cancer treatment. Biologics now
account for about 40% of all U.S. drug spending and 70% of spending
growth from 2010 to 2015.
Biosimilar medicines are deemed by FDA to be highly similar to
an already-approved biologic product. They fill an urgent and unmet
need for more affordable alternatives to biologic therapies,
increasing access and providing savings for patients and the
overall healthcare system. It's estimated that the introduction of
biosimilars in the U.S. could save the nation's healthcare system
up to $150 billion between 2017 and
2027.
Ogivri will be launched at a competitive discount for customers
to help ensure access and increase treatment options for
patients.
About the Biocon and Mylan Partnership
Mylan and Biocon Biologics are exclusive partners on a broad
portfolio of biosimilar and insulin products. Our biosimilar
trastuzumab is one of the 11 biologic products being co-developed
by Mylan and Biocon for the global marketplace. Mylan has exclusive
commercialization rights for the product in the U.S., Canada, Japan, Australia, New
Zealand and in the European Union and European Free Trade
Association countries. Biocon has co-exclusive commercialization
rights with Mylan for the product in the rest of the world.
About Mylan
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which approximately 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. We are one of
the world's largest producers of active pharmaceutical ingredients.
Every member of our more than 35,000-strong workforce is dedicated
to creating better health for a better world, one person at a time.
Learn more at Mylan.com. We routinely post information that
may be important to investors on our website
at investor.mylan.com.
About Biocon Limited
Biocon Limited, publicly listed in 2004, (BSE code:
532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led
global biopharmaceuticals company committed to enhance affordable
access to complex therapies for chronic conditions like diabetes,
cancer and autoimmune. It has developed and commercialized novel
biologics, biosimilars, and complex small molecule APIs in
India and several key global
markets as well as generic formulations in the US and Europe. It also has a pipeline of promising
novel assets in immunotherapy under development.
www.biocon.com Follow-us on Twitter: @bioconlimited
Biocon Biologics is a subsidiary of Biocon Ltd. It
is uniquely positioned as a fully integrated 'pure play'
biosimilars organization in the world and aspires to transform
patient lives through innovative and inclusive healthcare
solutions. The Company's portfolio of biosimilar molecules,
comprises a rich pipeline of approved and in-development
biosimilars which are an outcome of its high end R&D and global
scale manufacturing expertise. The Company has commercialized three
of its biosimilars in the developed markets like EU, U.S.,
Japan and Australia. It is a leading global insulins
player with over 15 years of experience in addressing the needs of
patients with diabetes, having provided over 2 billion doses of
human insulin worldwide, thus far. Follow-us on Twitter:
@BioconBiologics
Forward-Looking Statements: Mylan
This press release includes statements that constitute
"forward-looking statements," including with regard to that Mylan
and Biocon Biologics have sufficient manufacturing capacity to
fulfil demand in the U.S. and global markets for Ogivri and
Fulphila; that Mylan and Biocon look forward to continuing our work
with all stakeholders in the healthcare system to reduce costs,
improve access and advance care; that the product is brought to
market without legal risk; and that the introduction of biosimilars
in the U.S. could save the nation's healthcare system up to
$150 billion. Because
forward-looking statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such statements. Factors that
could cause or contribute to such differences include, but are not
limited to any changes in, interruptions to, or difficulties with
Mylan's or its partners' ability to develop, manufacture, and
commercialize products; the effect of any changes in Mylan's or its
partners' customer and supplier relationships and customer
purchasing patterns; other changes in third-party relationships;
the impact of competition; changes in the economic and financial
conditions of the businesses of Mylan or its partners; the scope,
timing, and outcome of any ongoing legal proceedings and the impact
of any such proceedings on Mylan's or its partners' business; any
regulatory, legal, or other impediments to Mylan's or its partners'
ability to bring products to market; actions and decisions of
healthcare and pharmaceutical regulators, and changes in healthcare
and pharmaceutical laws and regulations, in the United States and abroad; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; risks associated with international
operations; other uncertainties and matters beyond the control of
management; and the other risks detailed in Mylan's filings with
the Securities and Exchange Commission. Mylan undertakes no
obligation to update these statements for revisions or changes
after the date of this release.
Forward-Looking Statements: Biocon
This press release may include statements of future expectations
and other forward-looking statements based on management's current
expectations and beliefs concerning future developments and their
potential effects upon Biocon and its subsidiaries/ associates.
These forward-looking statements involve known or unknown risks and
uncertainties that could cause actual results, performance or
events to differ materially from those expressed or implied in such
statements. Important factors that could cause actual results to
differ materially from our expectations include, amongst other:
general economic and business conditions in India and overseas, our ability to
successfully implement our strategy, our research and development
efforts, our growth and expansion plans and technological changes,
changes in the value of the Rupee and other currency changes,
changes in the Indian and international interest rates, change in
laws and regulations that apply to the Indian and global
biotechnology and pharmaceuticals industries, increasing
competition in and the conditions of the Indian and global
biotechnology and pharmaceuticals industries, changes in political
conditions in India and changes in
the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or
any of our subsidiaries/associates assume any obligation to update
any particular forward-looking statement contained in this
release.
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SOURCE Mylan N.V.