European Commission Approves FYB201/Ranivisio®(1) (Ranivisio - Ranibizumab), a Biosimilar to Lucentis®(2)
AMSTERDAM, the Netherlands, MUNICH, Germany and ZUG, Switzerland, August 29, 2022 / B3C newswire / -- Polpharma Biologics Group BV (“Polpharma Biologics”), Formycon AG (“Formycon”) and Bioeq AG (“Bioeq”) jointly announce that the European Commission (“EC”) has granted marketing authorization (“MA”) to Ranivisio® (Ranivisio - Ranibizumab), a biosimilar to Lucentis® (ranibizumab-injection), for the treatment for several serious retinal diseases in the European Union (“EU”).i
EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.
Ranivisio® 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), the treatment of proliferative diabetic retinopathy (PDR), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).i
FYB201/Ranivisio® was developed by Bioeq, a Joint Venture between Polpharma Biologics and Formycon. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Europe and selected other countries. Commercial launches across Europe are planned over the coming year, and the treatment is already available in the UK under the tradename Ongavia®ii3, following its approval by the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
The EU-approval is based on the totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio® is highly similar to the reference product Lucentis® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration.i
AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits 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 and it is estimated that up to 77 million Europeans will be affected by 2050.iii The consequences of AMD carry a significant burden for healthcare systems and societies as the increasing incidence of the condition is expected to absorb considerable amounts of healthcare resources and funds across the EU.
“We are immensely pleased with this recognition by the European regulatory authorities of biosimilar ranibizumab. The production of biosimilars is a process with high levels of scientific rigor and the approval of Ranivisio® is the culmination of years of dedication by Polpharma Biologics, and our partners, to successfully engineer this medical advancement for those with severe retinal impairments,” says Michael Soldan, CEO of Polpharma Biologics. “We look forward to working with our strategic partners to rapidly get this very important treatment to the people across Europe who need it most.”
“Due to the demographic development more and more people in Europe are affected by age-related macular degeneration and other severe retinal diseases. This is very often accompanied by significant impairment of quality of life. We are therefore particularly pleased that FYB201/Ranivisio® - that we have developed together with Polpharma Biologics and Bioeq - can contribute to the treatment options of ophthalmologists and best possible care for these patients,” says Dr. Stefan Glombitza, CEO of Formycon AG.
1) Ranivisio® is a registered trademark of Bioeq AG.
2) Lucentis® is a registered trademark of Genentech Inc.
3) Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
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 six biosimilars in different stages of development, including PB006 (biosimilar natalizumab) recently accepted for review by the EMA and FDA.
Formycon 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. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars.
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.
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 2020, 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 the EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.
This press release is issued from Polpharma Biologics Group BV. Although Polpharma Biologics Group BV is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995) relating to the potential benefits, safety and efficacy of Ranivisio®; the timing and status of regulatory filings; risks and uncertainties associated with development and commercialization of drug products; plans, strategies and benefits related to cooperation between the entities named herein; projected increase in the incidence of certain diseases and associated potential costs for healthcare, as well as anticipated global sales of biosimilars. Recipients are cautioned that all forward-looking statements involve risks and uncertainties, including, but not limited to, the statements made in this press release.
Director, Ruder Finn
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i Ranivisio® (Ranivisio - Ranibizumab). EU Summary of Product Characteristics, August 2021. Available at: https://www.ema.europa.eu/en. Last accessed August 2022.
ii Ongavia® (ranibizumab). UK Summary of Product Characteristics, August 2021. Available at: https://www.medicines.org.uk/emc/product/13885/smpc/print. Last accessed August 2022.
iii Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084. Available at: https://bjo.bmj.com/content/104/8/1077. Last accessed August 2022.
Keywords: Humans; Ranibizumab; Macular Edema; Biosimilar Pharmaceuticals; Retinal Vein Occlusion; Diabetic Retinopathy; Choroidal Neovascularization; Wet Macular Degeneration; Vascular Endothelial Growth Factor; Retina; Diabetes Mellitus; European Medicines Agency; Blindness; Vision Disorders; Iceland; Liechtenstein; Norway; United Kingdom; European Union
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