EQS-News: Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis®

Press Release // December 07, 2023

Health Canada approves FYB201/Ranopto^® (Ranibizumab), a biosimilar to Lucentis^®

Munich, Amsterdam, Zug, Toronto – Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the “Notice of Compliance” (NOC) for Ranopto^®1 (Ranibizumab), a biosimilar to Lucentis^®2, for the treatment of several serious retinal diseases in Canada.

Ranopto^® is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).

FYB201/Ranopto^® was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and selected other countries. Commercial launch by Teva Canada Ltd. is expected to start in the first quarter of 2024.

AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina. In developed countries AMD is the most common cause of severe visual impairment or blindness. The risk of being affected increases with age. In Canada, approximately 2.5 million people are affected by AMD with nearly 180,000 experiencing vision loss [i].

“After successful launches in the U.S., Europe and countries of the MENA region, we are very pleased that – together with our partner Teva – we are now able to provide a highly effective and affordable treatment option to patients in Canada with severe retinal diseases. With the second highest per capita sales and third highest per capita consumption in the OECD, anti-VEGF therapies in Canada have been a significant burden on public drug plans in the past. With our biosimilar, we can contribute to more competition and cost efficiency in this important therapeutic area", says Dr. Stefan Glombitza, CEO of Formycon AG.

“The approval in Canada underlines the excellent work we have done together with our partners in the development of FYB201/Ranopto^®. It brings us a big step closer to our goal of improving therapy access for people with nAMD and other prevalent eye diseases worldwide, and thereby contributing to a better quality of life for millions of people affected", says Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group.

“Teva Canada is very pleased along with our partners to launch Ranopto^®. This marks an important milestone for our growing biosimilar portfolio and a new treatment option for Canadian patients with severe retinal disease as well as healthcare professionals”, says Michael Sine, General Manager Teva Canada.
 

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¹ Ranopto® is a registered trademark of Bioeq AG.
²Lucentis® is a registered trademark of Genentech, Inc.

About Formycon:
Formycon (ISIN: DE000A1EWVY8 / WKN: A1EWVY) is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development.

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch

About Polpharma Biologics:
Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. The company pipeline contains more than seven biosimilars in different stages of development, including PB006 (biosimilar natalizumab) recently approved by the EMA and FDA. www.polpharmabiologics.com

About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Currently, global sales of biosimilars are estimated at more than $15 billion. By 2030, analysts estimate that this figure could rise to over $74 billion.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

^[i] Larissa Moniz, Chad Andrews, Jennifer Pereira: „Canadian patient experience with age-related macular degeneration“ in ARVO Annual Meeting Abstract, June 2022 https://iovs.arvojournals.org/article.aspx?articleid=2781783