HERTFORDSHIRE, England and
PITTSBURGH and BENGALURU,
India, March 9, 2020 /PRNewswire/ -- Mylan
N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code:
532523, NSE: BIOCON) today announced that the U.S. Food and Drug
Administration (FDA) has accepted Mylan's Biologics License
Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin®
(bevacizumab), for review under the 351(k) pathway.
The BLA seeks approval of bevacizumab for first-line and
second-line treatment of patients with metastatic colorectal cancer
in combination with fluorouracil-based chemotherapy; first-line use
for patients with non-squamous non-small cell lung cancer;
recurrent glioblastoma; metastatic renal cell carcinoma in
combination with interferon alfa; and persistent, recurrent or
metastatic cervical cancer.
The FDA goal date set under the Biosimilar User Fee Act (BsUFA)
is Dec. 27, 2020.
Mylan and Biocon's proposed biosimilar bevacizumab is expected
to be the third biosimilar from the partnered portfolio for cancer
patients in the U.S. It is currently available in India and other developing markets.
Mylan President Rajiv Malik commented: "As we
continue toward our goal of expanding access to cancer treatments
for oncology patients, the FDA acceptance of our application for
proposed biosimilar bevacizumab is another important step forward
to increase competition, drive health system savings and expand our
growing oncology portfolio to provide a broad range of offerings.
We're encouraged by the results of our scientific program to date
and look forward to advancing the review of our
application."
Dr Christiane Hamacher, CEO,
Biocon Biologics, said: "The US FDA's acceptance of our BLA
for a proposed biosimilar bevacizumab co-developed by Biocon
Biologics and Mylan is an important milepost in our journey of
enabling access to affordable cancer therapies for patients. Once
approved, our proposed biosimilar bevacizumab will provide an
affordable alternative to the branded biologic for the approved
indications. Biocon Biologics' strong R&D and manufacturing
capabilities have enabled us to offer two key biosimilars to cancer
patients in the U.S. and bevacizumab will further expand our
oncology portfolio."
The BLA is supported by a global randomized, controlled phase 3
clinical trial to evaluate the efficacy, safety and immunogenicity
of proposed biosimilar bevacizumab versus Avastin. The study
included patients diagnosed with stage 4 non-squamous non-small
cell lung cancer. Eligible patients were randomised to receive
either the proposed biosimilar bevacizumab or Avastin along with
carboplatin and paclitaxel for up to six cycles (18 weeks). After
which the patients continued to receive monotherapy until week
42. Additionally, patients benefitting from the treatment
continued on bevacizumab monotherapy. The primary endpoint was
overall response at week 18, using RECIST 1.1. Secondary endpoints
included safety, progression free survival and overall survival at
week 18 and 42.
A total of 671 patients were randomized. At week 18, the study
met the primary endpoint and the 90% confidence interval for
the best ORR (objective response rate) ratio was within the
pre-specified equivalence margin. The safety which included
immunogenicity was found to be similar to Avastin.
About the Biocon and Mylan Partnership
Mylan and
Biocon Biologics are exclusive partners on a broad portfolio of
biosimilar and insulin products. Our proposed biosimilar
bevacizumab 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 the timing and outcome of clinical trials
and regulatory review; the statement that the FDA acceptance of our
application for proposed biosimilar bevacizumab is another
important step forward to increase competition, drive health system
savings and expand our growing oncology portfolio to provide a
broad range of offerings; we are encouraged by the results of our
scientific program to date and look forward to advancing the review
of application; and once approved, our proposed biosimilar
bevacizumab will provide an affordable alternative to branded
bevacizumab (Avastin) for cancer patients for the approved
indications. 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.
