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 The leading web portal for pharmacy resources, news, education and careers April 24, 2017
Pharmacy Choice - Pharmaceutical News - U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Pegfilgrastim for Review - April 24, 2017

Pharmacy News Article

 2/16/17 - U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Pegfilgrastim for Review

HERTFORDSHIRE, England, PITTSBURGH andBENGALURU, India, Feb. 16, 2017 /PRNewswire/ Mylan N.V. (NASDAQ, TASE: 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-1401H, a proposed biosimilar to Neulasta(pegfilgrastim), for filing through the 351(k) pathway.

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9, 2017.

Mylan President Rajiv Malik commented: "We're proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim. This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months. The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia, and Canada and reinforces our dedication and commitment to establishing a global platform for this product. Once approved, proposed biosimilar pegfilgrastim will complement Mylan's broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer."

Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: "We are extremely pleased with the regulatory progress of our biosimilars in the U.S. The FDA's acceptance for review of our second BLA for a proposed biosimilar developed by Biocon and Mylan is an outcome of our strong R&D and manufacturing capabilities. Once approved, our proposed biosimilar pegfilgrastim will provide a high quality alternative to branded pegfilgrastim (Neulasta) for cancer patients during cytotoxic chemotherapy. It will expand our oncology portfolio and further enable us to fulfil our promise of making cancer-care affordable and accessible for patients across the globe."

About the Biocon and Mylan Partnership
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed biosimilar pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar pegfilgrastim 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 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS worldwide depend. We market our products in more than 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and 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

About Biocon
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India's largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 100 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from 'Lab to Market'. Some of its key brands are INSUGEN (rh-insulin), BASALOG (Glargine), CANMAb? (Trastuzumab), BIOMAb-EGFR? (Nimotuzumab) and ALZUMAb? (Itolizumab), a 'first in class' anti-CD6 monoclonal antibody. It has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oralinsulin.

Forward-Looking Statements: Mylan
This press release includes statements that constitute "forward-looking statements," including with regard to the FDA goal date; that the FDA acceptance builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Canada, Europe and Australia and reinforces Mylan's dedication and commitment to establishing a global platform for the product; that once approved, proposed biosimilar pegfilgrastim will complement Mylan's broad oncology portfolio focused on expanding access to more affordable treatments for all stages of cancer; and that proposed biosimilar pegfilgrastim, once approved, will provide a high quality alternative to branded pegfilgrastim for cancer patients during cytotoxic chemotherapy. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any changes in or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights; 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; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; 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
Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those contemplated in such forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, 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 biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither our company, our directors, nor any of our affiliates, have any obligation to update or otherwise revise any statements reflecting circumstances arising after this date or to reflect the occurrence of underlying events, even if the underlying assumptions do not come to fruition.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/us-fda-accepts-biologics-license-application-bla-for-mylan-and-biocons-proposed-biosimilar-pegfilgrastim-for-review-300408246.html

SOURCE Mylan N.V.




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