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TORONTO and BENGALURU, India, May 19, 2022 /PRNewswire/ -- Viatris Inc. and Biocon Biologics Ltd., a subsidiary of Biocon Ltd., announced today that Abevmy® (bevacizumab) is now available in Canada. Abevmy, co-developed by Viatris and Biocon Biologics, is a biosimilar to Roche's Avastin® (bevacizumab) and has been approved by Health Canada across four oncology indications.
Viatris Canada Country Manager David Simpson commented: "With patients at the heart of what we do, we are proud to bring Abevmy to market to provide increased access and affordability in oncology. Abevmy is the fourth biosimilar to be offered by Viatris in Canada and our third to support patients living with cancer. Our vast experience in biosimilars has resulted in a substantial oncology portfolio which expands choices for patients across the nation."
Matthew Erick, Chief Commercial Officer, Advanced Markets, Biocon Biologics, said: "With the launch of Abevmy, we are adding another world-class biosimilar to our oncology portfolio in Canada, which includes Ogivri (trastuzumab) and Fulphila (pegfilgrastim). Abevmy will be an important addition to our existing portfolio and will enable us to expand patient access to another affordable biologic for cancer care."
Abevmy follows the launch of our two oncology biosimilars in Canada, Ogivri (trastuzumab) in 2019 – the first trastuzumab approved in the country – and Fulphila (pegfilgrastim), which was launched in 2020. In addition to the therapeutic area of oncology, Viatris Canada launched Hulio (adalimumab) in February 2021 for chronic inflammatory conditions.
The Viatris Advocate™ program is also now available for Abevmy. The program offers support and resources for patients, their caregivers and their healthcare providers.
The approval of Abevmy was based on a comprehensive analytical, pre-clinical and clinical program. Abevmy is authorized for use in the following indications:
The two formats approved and now available in Canada are: 100 mg/4 mL single-use vial and 400 mg/16 mL single-use vial.
Abevmy is a recombinant humanized monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Abevmy inhibits the formation of tumor vasculature, thereby inhibiting tumor growth.
About the Viatris and Biocon Biologics Collaboration
Viatris and Biocon Biologics have an exclusive collaboration for the development, manufacturing and commercialization of a broad portfolio of biosimilars and insulin analogs. Viatris has exclusive commercialization rights in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon Biologics has exclusive commercialization rights for certain emerging markets and co-exclusive commercialization rights with Viatris in the rest of the world.
In February 2022, the two Companies reached a definitive agreement wherein Biocon Biologics will acquire substantially all of Viatris' biosimilars portfolio globally, including Abevmy. The transaction will create a uniquely positioned, vertically integrated company that is expected to be a global biosimilars leader. Upon closing, Viatris will continue to participate in the global biosimilars market through an equity stake of at least 12.9% on a fully diluted basis in Biocon Biologics. The close of the transaction is currently expected to occur in the second half of 2022 subject to satisfaction of closing conditions, including certain regulatory approvals.
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars and a variety of over-the-counter consumer products. With approximately 37,000 colleagues globally, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube.
About Biocon Biologics Limited
Biocon Biologics Ltd., a subsidiary of Biocon Ltd., is a unique, fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower costs of biologics therapies while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology and other non-communicable diseases. Seven molecules from Biocon Biologics' portfolio have been commercialized in key emerging markets and developed markets like U.S., EU, Australia, Canada, Japan. It has many firsts to its credit including the most recent U.S. FDA approval of the world's first interchangeable biosimilar, awarded to its Insulin Glargine, which has been commercialized in the U.S. in 2021. Biocon Biologics has signed a strategic alliance with Serum Institute Life Sciences (subject to certain closing conditions) to address the inequitable access to life saving vaccines and biologics globally. With a team of ~5,000 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients' worldwide. Website: www.bioconbiologics.com; Follow us on Twitter: @BioconBiologics for company updates.
Viatris - Forward-looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements about the launch of Abevmy® (bevacizumab) in Canada, the Viatris Advocate program, and the Biocon Biologics Transaction (as defined below); that in February 2022, the two companies reached a definitive agreement wherein Biocon Biologics will acquire substantially all of Viatris' biosimilars portfolio globally, including Abevmy; the transaction will create a uniquely positioned, vertically integrated company that is expected to be a global biosimilars leader; that upon closing, Viatris will continue to participate in the global biosimilars market through an equity stake of at least 12.9% on a fully diluted basis in Biocon Biologics; and that the close of the Biocon Biologics Transaction is currently expected to occur in the second half of 2022 subject to satisfaction of closing conditions, including certain regulatory approvals. 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: the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by the COVID-19 pandemic; that the pending transaction between Viatris and Biocon Biologics Limited, pursuant to which Viatris will contribute its biosimilar products and programs to Biocon Biologics in exchange for cash consideration and a convertible preferred equity interest in Biocon Biologics (the "Biocon Biologics Transaction"), may not achieve its intended benefits; the integration of Mylan N.V. and Pfizer Inc.'s Upjohn business (the "Upjohn Business"), which combined to form Viatris (the "Combination") and the implementation of our global restructuring initiatives being more difficult, time consuming or costly than expected, or being unsuccessful; the ability to achieve expected benefits, synergies, and operating efficiencies in connection with the Combination or its restructuring initiatives within the expected timeframe or at all; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this release other than as required by law.
Biocon - Forward-Looking Statements:
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.