Bengaluru, India and Toronto, Canada, May 19, 2022
Biocon Biologics Ltd., a subsidiary of Biocon Ltd., and Viatris Inc. (NASDAQ: VTRS) announced today that Abevmy® (bBevacizumab) is now available in Canada. Abevmy, co-developed by Biocon Biologics and Viatris, is a biosimilar to Roche’s Avastin® (Bevacizumab) and has been approved by Health Canada across four oncology indications.
Matthew Erick, Chief Commercial Officer, Advanced Markets, Biocon Biologics, said: “With the launch of Abevmy, (bBevacizumab), 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.”
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.”
Abevmy follows the launch of our two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020. In addition to the therapeutic area of oncology, Viatris Canada launched Hulio (bAdalimumab) in February 2021 for chronic inflammatory conditions.
The Viatris AdvocateTM 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:
- Metastatic Colorectal Cancer (mCRC)
- Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
- Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
- Malignant Glioma (WHO Grade IV) – Glioblastoma
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 (bBevacizumab), inhibits the formation of tumor vasculature, thereby inhibiting tumor growth.
About the Biocon Biologics and Viatris Collaboration
Biocon Biologics and Viatris 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.
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 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 a global workforce of approximately 37,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Pennsylvania, Shanghai, China, and Hyderabad, India.